vectorvision osteotomy...brainlab accessories comment mira (diam. 5mm, y and t design) reference...

VECTORVISIONOSTEOTOMYVersion 1.0

Clinical User GuideRevision 1.2Copyright 2011, Brainlab AG Germany. All rights reserved.

Clinical User Guide Rev 1.2 VectorVision osteotomy Ver 1.0 i

TABLE OF CONTENTS

TABLE OF CONTENTSPREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Warnings and Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Important . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Using the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Compatibility with Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Brainlab Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Non-Brainlab Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Other Software Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Additional Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Platform Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

About Wireless Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

About the Osteotomy Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Background Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Overview of the Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Factors in Leg Alignment Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

WORKFLOW FOR OSTEOTOMY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

SYSTEM STARTUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

System Setup in the Operating Room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Preparation for Registration and Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Turning on the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Initial Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Identifying the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Defining the Treatment Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

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Planning the Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

SOFTWARE OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Menu Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Camera Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Status Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

System Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Toolbox Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

View Management Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Navigation Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Tracking Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Information Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

REGISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Registration Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Plausibility Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Registration Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Registration Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Hip Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Medial and Lateral Malleolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Tibial Contours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Tibial A-P Direction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Femoral Epicondyles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Additional Registration Steps With Arthroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Tibial Tuberositas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Accuracy Check Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

NAVIGATION OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Intraoperative Tracking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Available Workflows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Navigation Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

NAVIGATION: OPENING WEDGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Navigation Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Defining the Initial Leg Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

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Planning the Resection Plane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Attaching the Reference Array to the Tibia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Navigating the Tibia Resection Plane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Opening Wedge Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Attaching the Reference Array to the Femur . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Motion Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

NAVIGATION: CLOSING WEDGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Navigation Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Defining the Initial Leg Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Planning the Resection Plane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

Navigation of the Proximal Tibia Resection Plane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Navigation of the Distal Tibia Resection Plane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Closing Wedge Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Motion Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

ADDITIONAL NAVIGATION FUNCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Motion Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Navigation Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

Accuracy Checkpoints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Alignment Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Digitize Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

SYSTEM SHUTDOWN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Closing the Software and Shutting Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Restoring Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

INSTRUMENTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Using Fixation Pins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Brainlab Pointer, Sharp Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Pointer Angled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Minimally Invasive Reference Array (Diam. 5mm, Y-Design) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

Attaching the MIRA (Y-Design) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Minimally Invasive Reference Array (Diam. 5mm,

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T-Design) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

MI Reference Array Kit Osteotomy, X-Press . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Bone Fixator “1-Pin”, X-Press . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Bone Fixator “2-Pin”, X-Press . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Bone Fixators, X-Press: Attachment Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Reference Array, X-Press . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Drill Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Assembling the Drill Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

Drill Guide Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Drill Guide Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Femoral and Tibial Cutting Block Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Attaching the Femoral and Tibial Cutting Block Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Femoral and Tibial Cutting Block Adapter “Universal” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Assembling the Femoral and Tibial Cutting Block Adapter “Universal” . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Attaching the Femoral and Tibial Cutting Block Adapter “Universal” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Disposable Reflective Marker Spheres . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I

Clinical User Guide Rev 1.2 VectorVision osteotomy Ver 1.0 1

1 PREFACE1.0.1 Overview

This guide provides an introduction and reference for the effective and correct use of Brainlab’s VectorVision osteotomy software. This guide is written for all members of the clinical team who use or handle the VectorVision osteotomy system or parts of it. You should read this guide care-fully and acquaint yourself sufficiently with the system before use.

Support If you cannot find the information you need in this guide, please contact Brainlab customer support:

Copyright This guide contains proprietary information protected by copyright. No part of this book may be re-produced or translated without the express written permission of Brainlab.

Liability The information in this guide is subject to change without notice and does not represent a commit-ment on the part of Brainlab. For further information on the subject of liability, please refer to the Lim-itations of Liability section in Brainlab’s Standard Terms and Conditions of Sale.

Feedback Despite careful review, errors may appear. We look forward to your comments and suggestions, and can be contacted at [email protected], or via telephone at +49-89-991568-44 or (800) 597-5911.

Trademarks • VectorVision® is a registered trademark of Brainlab in Germany and/or the US.

• VectorVision osteotomyTM is a trademark of Brainlab, registration pending.

• Microsoft® and Windows® are registered trademarks of Microsoft Corporation

CE Label The CE mark shows that Brainlab’s VectorVision osteotomy complies with the essential requirements of the Medical Device Directive. According to the MDD (Council Directive 93/42/EEC), VectorVision osteotomy is a Class IIa product.

Manufacturer Brainlab AG - Ammerthalstr. 8 - D-85551 Heimstetten - Germany

United States and Canada (800) 597-5911 (708) 409-1619 (fax)

Africa, Asia, Australia, Europe, Latin America, South America

+49-89-991568-44 +49-89-991568-33 (fax)

Internet, worldwide [email protected] www.brainlab.com

2 Clinical User Guide Rev 1.2 VectorVision osteotomy Ver 1.0

Symbols The following symbols may be found on the system:

Class I, Type B equipment according to IEC 601-1

Attention! Please consult accompanying documents

Potential equalization point

S/N

Serial number of instruments: XXXX-YY-XX-XXXX-X

Serial number of navigation stations: YY-XXX-XXXXX

YY specifies the manufacturing year of the device


1.1 Warnings and Caution

This guide uses the following cues to alert you to safety-critical information.

Warnings are used to alert the user to possible injury, death or other serious conse-quences associated with the use or misuse of the equipment.

Cautions are used to alert the user to the possibility of a problem with the device as-sociated with its use or misuse. Such problems include device malfunctions, device failure, damage to the device or damage to property.


1.1.1 Important

All information input to the VectorVision osteotomy system and all information re-ceived from the VectorVision osteotomy system as output must be reviewed regarding its plausibility before patient treatment.

The VectorVision osteotomy system components and accessory instrumentation comprise precise mechanical parts which must be handled with care.

VectorVision osteotomy system components and accessory instrumentation may only be operated by trained medical personnel.

U.S. federal law restricts the sale of this product by or on the order of a physician.


1.2 Indications for Use

1.2.1 Using the System

Brainlab VectorVision is intended to be an intraoperative image-guided localization system to eable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient’s bone, which is generated through acquiring multiple landmarks on the bone surface.

The system is indicated to assist a surgeon to perform one (open wedge) or two (closed wedge) cuts to achieve a leg angle correction.

Example orthopedic surgical procedures include but are not limited to:

• Open wedge osteotomy for the lower limb

• Closed wedge osteotomy for the lower limb


1.3 Compatibility with Medical Devices

1.3.1 Brainlab Accessories

VectorVision osteotomy is compatible with the following medical devices manufactured by Brain-lab AG:

Only accessories and spare parts specified by Brainlab may be used with this medical device. Using unauthorized accessories/spare parts may adversely affect the safety and/or the effectiveness of the medical device and endanger the safety of the patient, user and/or environment.

Brainlab Accessories Comment

MIRA (Diam. 5mm, Y and T design)

Reference Array, X-Press (Y-Geometry and T-Geometry)

Bone Fixator “1-Pin”, X-Press Size M

Bone Fixator “2-Pin”, X-Press

Brainlab Pointer, Sharp Tip and Pointer Angled

Drill Guide

Femoral and Tibial Cutting Block Adapter

Femoral and Tibial Cutting Block Adapter “Universal”


1.3.2 Non-Brainlab Medical Devices

VectorVision osteotomy is compatible with the following non-Brainlab medical devices:

VectorVision osteotomy also supports universal implant settings, which allow implants from vari-ous manufacturers to be integrated.

Only those non-Brainlab medical devices specified above may be used with this med-ical device. Using medical device combinations which have not been authorized by Brainlab may adversely affect the safety and/or the effectiveness of the medical device and endanger the safety of the patient, user and/or environment.

Product Comment

Threaded K-wires Up to diameter 3.0mm


1.3.3 Other Software Providers

• Portions of this software are based in part on the CyberVrmI97 package written by Satoshi Konno.

• This software is based in part on the work of the Independent JPEG Group.

• This software uses the “SOLID Interface Detection Library Version 2.0” written by Gino van de Bergen.


2 INTRODUCTION2.1 About this Manual

This guide is written for all members of the clinical team who use or handle the VectorVision osteotomy system or parts of it. Access should be provided to the relevant VectorVision osteotomy user manuals at all times.

As well as an introduction to wireless navigation, it provides detailed information on how to use the VectorVision osteotomy software and accessory instrumentation to correctly plan and carry out knee navigation.

System setup in the operating theater prior to surgery is also described, and flowcharts illustrating the most important steps involved in performing knee treatments with VectorVision osteotomy are also provided.


2.2 Additional Documentation

The following user manuals are also available for VectorVision osteotomy:

• VectorVision System User Guide: Provides detailed technical information on the VectorVision navigation station, and compre-hensive information on system setup.

• VectorVision Cleaning, Disinfection & Sterilization Guide: Provides detailed information on cleaning, disinfecting and sterilizing instrumentation.


2.3 Overview

2.3.1 Platform Information

VectorVision osteotomy is available on the following Brainlab navigation stations:

• VectorVision2

• VectorVision compact

• VectorVision sky

Figure 1VectorVision compact and VectorVision2

Figure 2VectorVision sky

All three navigation stations facilitate intra-operative image-guided planning and navigation. More information is provided in the VectorVision System User Guide.


2.3.2 About Wireless Navigation

VectorVision osteotomy is a touchscreen-based planning and navigation software, designed for use in orthopedic surgery. It is a wireless navigation system, which means that unlike traditional nav-igation systems, no cables, batteries, or foot switches are required.

Instead, the system uses passive marker spheres, and two infrared cameras which emit infrared flashes.

The passive marker spheres are mounted to the surgical instrument, and to one or more reference arrays which are securely attached to the patient’s bone structure. Each passive marker sphere re-flects the infrared flashes from the cameras, creating an individual infrared reflection image.

These images are digitized by both cameras, each of which “sees” the marker spheres from a dif-ferent angle. The software then uses this information to calculate the three-dimensional position of the instrument marker spheres relative to the position of the reference array marker spheres. Once patient registration has been completed, the position of the surgical instrument relative to the patient can then be accurately determined.

Figure 3Wireless Navigation

The surgical instruments can now be tracked throughout the operation using a connected touch-screen monitor. All the features of the VectorVision osteotomy software are also accessed via this touchscreen monitor.

So that the VectorVision osteotomy wireless navigation system can operate effectively, the cam-eras must have an unobstructed view of the marker spheres at all times during the surgical proce-dure. This requires careful procedural planning and site preparation. It is important, therefore, that this manual is read carefully before beginning a procedure.

In order to ensure safe and appropriate use of the system, Brainlab also recommends that before using the system for the first time, all users should participate in an extensive training program held by a Brainlab representative. After a sufficient number of complete procedures has been success-fully simulated on sawbones and/or cadavers, the system can be used in selected operations where computer-aided navigation may be desirable but not essential. A Brainlab representative must be present at such operations to provide the surgeon with guidance where necessary. Once the user has gained sufficient experience with the system, and fulfilled all training requirements, the system may then be implemented for surgical procedures where computer-aided navigation is considered essential.

This system solely provides additional assistance to the surgeon and does not by any means substitute or replace the surgeon’s experience and/or responsibility during its use.


2.3.3 About the Osteotomy Software

VectorVision osteotomy is a touchscreen-based intra-operative planning and navigation software, designed for use in orthopedic surgery. It can be installed on Brainlab’s VectorVision², VectorVision compact or VectorVision sky navigation station.

VectorVision osteotomy has an integrated CT database of healthy and arthritic knees. For this rea-son, scan images of the patient do not need to be acquired before the operation. Registration is also performed intra-operatively. Standard workflows are provided for the selected procedure together with integrated navigation functions and image views.

The patient is positioned as usual in the supine position, and draped in the usual manner. The cam-eras must be positioned so they have an unobstructed view of the surgical area at all times.

Before commencing treatment, the surgeon should always check that:

• the correct patient name is shown on the screen

• the specified orientation (left-right, and medial-lateral), corresponds exactly with the patient position on the operating table

To enable registration, a reference array must attached to the bone to be operated upon. Patient registration is now completed by sliding the pointer tool across the required surface area or by piv-oting the pointer at the required location. The software uses this information to register the initial leg geometry. The surgeon can then record the initial leg alignment in extension.

To ensure that the registration accuracy is maintained, VectorVision osteotomy regularly prompts the surgeon to perform accuracy checks during the surgical procedure. An additional accuracy check continuously monitors the alignment of the mechanical axis and displays a warning message if the position of the mechanical axis is shifted from the recorded position.

The osteotomy site is planned by using the pointer to define the resection plane on the tibia. The software uses this information, along with the mechanical axis acquired during registration, to cal-culate the amount of correction required to achieve the desired postoperative leg alignment.

The software displays the planned resection plane on the screen as well as the depth of the planned cut. A cutting block or K-wires are navigated to the planned resection plane, and the tibia can be resected according to standard surgical procedure.

The VectorVision osteotomy software may only be used for knee treatments. Do not use the software for any other treatments.


2.4 Background Information

2.4.1 Overview of the Procedure

The goal of high tibial osteotomy surgery is to realign the mechanical axis in a knee joint that has a unicompartmental defect so that weight bearing is shifted from the diseased side to the healthier side of the joint.

In order to realign the leg, the amount of correction is first determined. The tibia is then resected, and the resulting wedge is aligned in order to shift the mechanical axis to achieve the desired post-operative leg alignment.

VectorVision osteotomy supports navigation of the opening wedge and closing wedge procedures.

Opening Wedge • If you are performing the opening wedge procedure, you must first record the initial leg align-ment in order to provide the system with information about the preoperative leg defect.

• The resection plane on the tibia is then defined by acquiring the start point and end point of the cutting plane using the pointer. The software uses the end point you define as the reference for the initial center of rotation, and calculates the resection plane between the center of rotation and the cutting plane start point. You can also choose to skip definition of the resection plane end point and start point. In this case, additional adjustment functions will be available allowing you to manually determine the center of rotation and resection plane on the tibia.

• The software displays a virtually resected tibia showing the amount of correction required, based on the initial leg alignment.

Figure 4Opening Wedge Alignment

• If required, you can adjust the planned wedge in order to adjust the desired post-operative leg alignment.

• Once planning is complete, you can navigate either a cutting block or K-wires to the planned resection plane.

• After the tibia has been resected, you can adjust the wedge opening in order to align the leg to the planned alignment displayed by the software.


Closing Wedge • If you are performing the closing wedge procedure, you must first record the initial leg alignment in order to provide the system with information about the preoperative leg alignment.

• The proximal resection plane on the tibia is then defined by acquiring the start point and end point of the cutting plane using the pointer. The software uses the end point you define as the reference for the initial center of rotation and calculates the resection plane between the center of rotation and the cutting plane start point. You can also choose to skip definition of the resec-tion plane end point. In this case, additional adjustment functions will be available allowing you to manually determine the center of rotation and resection plane on the tibia.

• In the case of the closing-wedge procedure, the software calculates the position of the distal resection plane so that it intersects with the proximal resection plane at the center of rotation. The software displays both resection planes on the bone and shows a virtually resected tibia with the amount of correction required based on the initial leg alignment.

Figure 5Closing Wedge Alignment

• You can then rotate the distal plane relative to the proximal plane in order to plan the desired post-operative leg alignment.

• Once planning is complete, you can navigate either a cutting block or K-wires to the planned position of the proximal and distal resection planes, and resect the tibia according to standard surgical procedure.

• In final leg alignment, you can close the wedge and compare the achieved leg alignment to the planned alignment.

Navigating Leg Alignment Only

• VectorVision osteotomy also allows you to navigate leg alignment when performing opening wedge osteotomy (see Page 14) without navigating the resection plane on the tibia. In this case you can simply skip definition of the tibia resection plane during the planning steps.

• With this option, additional adjustment steps are required in the planning steps to manually position the center of rotation and resection plane as accurately as possible to where the actual cut will be placed. The additional adjustments provide the software with information about the resection plane so that the virtually resected bone and leg movement can be displayed as accu-rately as possible in the subsequent steps.

• Once the leg alignment is planned, you can proceed directly to final cut alignment once the tibia has been resected without navigation. The software will display the actual leg alignment relative to the planned alignment.

The navigation steps are described in detail in the relevant navigation chapter (opening wedge pro-cedure from Page 71, closing wedge procedure from Page 93). The table on Page 68 provides an overview of the required steps for the available procedures.


2.4.2 Factors in Leg Alignment Planning

The system uses various angles and axes as references when planning the post-operative leg align-ment. These values are calculated during initial leg alignment based on points acquired on the tibia and femur during registration (see Page 45).

During planning, the software displays important values, which can then be adjusted if required.

Figure 6Leg Alignment Values: Example

• The following important values are shown:

- Mechanical leg axis (hip-ankle line, 1)

- Tibial joint-line axis (2)

- Intersection point (3)

- Varus/valgus angle

- Medial proximal tibial angle (MPTA)

- Hip-ankle line length and deviation

Mechanical Axis • Tibia

- The mechanical axis acts as a reference for varus/valgus alignment, and as a reference for the posterior slope.

- The mechanical axis end point is defined by acquiring one point on the medial malleolus and one point on the lateral malleolus (see Page 55). After the calculation of the mid-point of the malleolus axis, the system defines this point at a distance of 46% from the medial and 54% from the lateral malleolus.

- If you are performing registration using arthroscopy (see Page 53), a third point is acquired on the tibia plateau (see Page 61). This serves as the start point of the tibial mechanical axis.

- If you are registering without arthroscopy, the start point of the tibial mechanical axis is calcu-lated as the mid point of the medial and lateral tibial contours (see Page 56).

• Femur

- The mechanical axis acts as a reference for varus/valgus alignment, and as a reference for alignment in flexion/extension.

- Registering the rotational center of the femoral head (see Page 54) defines the proximal point of the femoral mechanical axis and the start point of the weight bearing axis (Mikulicz line).

- If you are performing registration using arthroscopy (see Page 53), a point is acquired on the distal end of the femoral mechanical axis (see Page 60). This serves as the end point of the femoral mechanical axis.

- If you are performing registration without arthroscopy, the end point of the femoral mechani-cal axis is calculated as the mid point of the medial and lateral epicondyles (see Page 58).

- The mechanical axis of the entire leg (hip-ankle line) is determined from the definition of the femoral head and the mid-point of the malleolus axis.


Hip/Ankle Line • The system calculates the leg length according to the hip-ankle line, and will track the leg length based on adjustments made during planning. The software will display the actual leg length rel-ative to the initially defined length during the planning and final wedge alignment steps.

Tibial Joint-Line Axis

• The tibial joint-line axis is calculated by acquiring a point on both the medial and lateral tibial contours (see Page 56).

Intersection Point • The intersection point of the mechanical leg axis and the tibial joint line axis is used as a refer-ence for determining the amount of correction required. The software calculates the intersection point and automatically shifts the mechanical axis to achieve the following values.

- With a medial defect, the software aligns the leg so that the mechanical axis intersects the tib-ial plateau at 62% of the total medial-lateral tibial diameter (measured from the lateral side), in order to achieve a valgisation.

- With a lateral defect, the software aligns the leg so that the mechanical axis intersects the tib-ial plateau at 38% of the total medial-lateral tibial diameter (measured from the lateral side), in order to achieve a varisation.

- The position of the intersection point can then be adjusted in the planning steps.

Varus/Valgus • The varus/valgus angle of the leg is calculated from registration of the mechanical axis, and provides an important reference when determining the required amount of correction.

• The varus/valgus angle will be recalculated with adjustments made to the intersection point. The varus/valgus angle can also be adjusted in the planning steps.

Medial Proximal Tibial Angle

• The medial proximal tibial angle (MPTA) provides another reference for determining the required correction. A malrotation of the tibial plateau can be measured and taken into account during planning.

• The MPTA is calculated by the definition of the tibial joint-line axis and the tibial mechanical axis.

Tibial Slope • If you are performing registration with arthroscopy, the tibial slope is registered by acquiring points on the medial and lateral tibial plateaus (see Page 61).

• If you selected registration with arthroscopy, the tibial slope is defined perpendicular to the tibial mechanical axis (see Page 61).

• The software uses the registered tibial slope to align the anterior-posterior position of the resec-tion plane parallel to the slope to ensure that the tibial plateaus will not be resected. The tibial slope can then be adjusted, if required, in the planning steps.

• In the final wedge alignment step, the software displays the achieved tibial slope relative to the slope acquired during registration.

• If you are performing the closing wedge procedure, the tibial slope can be adjusted during the final wedge alignment step and the corresponding rotation of the tibial plateau can then be esti-mated.

Drape Patient

Turn on System and Drape Touch-screen

Perform Incision and Prepare Leg

Select Initial Settings ()

Perform Registration (Page 54)

Attach Reference Arrays (Page 46)

(Page 46)

Clinical User Guide Rev 1.2 VectorVision Osteotomy Ver 1.0 19

3 WORKFLOW FOR OSTEOTOMY

Perform Selected Navigation Procedure (Page 68) (Page 68)

Perform Additional Registration Steps (Page 59) (Page 54)

Set up Arthroscopy Equipment (Optional) (Page 54)

Perform Motion Analysis (Optional) (Page 115) (Page 54)

20 Clinical User Guide Rev 1.2 VectorVision Osteotomy Ver 1.0


4 SYSTEM STARTUP4.1 System Setup in the Operating Room

• Move the system into the desired position.

The VectorVision system can be positioned either at the side or at the end of the operating table. The surgeon should be positioned on the opposite side of the VectorVision system.

Figure 7Patient and System Setup in the OR

• If MRI equipment is located in the OR, ensure that the monitor is outside the 5 Gauss limit when positioning the system.

Do not use equipment which is not MRI-compatible near an MRI scanning system.

• Adjust the cameras to the required position. In order to provide an optimum view, the cameras should be at a distance of approximately 2m (approx. 6.5 feet). If an arthroscope is being used, make sure that the marker spheres attached to tracking arrays will not be obscured by the opti-cal arthroscopy unit during arthroscopy and registration.

• To allow for intra-operative camera positioning, slide the sterilizable camera handle sleeve over the handle of the camera joint.

• Adjust the monitor to a position most convenient for and accessible by the surgeon.

• To allow for intra-operative use by the surgeon, drape the monitor with a clear custom drape available from Brainlab.

• Plug in and turn on the system using the power switch.

The camera and monitor should not restrict the field of movement of the OR team. The marker spheres should not be obstructed from the view of the infrared cameras, and should be clearly visible at all times.

Detailed information on system transport and setup is provided in the VV System User Guide.

The measurement precision in a plane perpendicular to the viewing direction of the cameras is higher than the precision along the direction of the camera view. To enable maximum precision, this should be taken into account when attaching the reference array to the patient.


The cameras must be positioned so that they have an unobstructed view of all refer-ence arrays in the surgical field.

The navigation station may create interference which could affect the operation of oth-er equipment. In particular, the infrared light of the tracking system may cause inter-ference which could affect IR-based OR equipment.


4.2 Preparation for Registration and Navigation

Before beginning the procedure, make sure you are familiar with the correct handling of the required Brainlab instruments and accessories.

The following steps are required before the registration and navigation procedure can begin:

• Turn on the system (see Page 24).

• Drape the touchscreen.

• Drape the patient, perform the incision, and prepare the leg in the usual manner.

• Enter the patient name and ID (see Page 25).

• Define the treatment side (see Page 26).

• Define the osteotomy options (see Page 27).

• Attach the selected reference arrays to the patient.

• Check the visibility of the reference arrays and the surgical instruments tools (see Page 31).

Once these steps have been completed, you can begin patient registration as described fromPage 45.


4.3 Turning on the System

If only the VectorVision osteotomy application is installed on the system, the software starts auto-matically once the system is turned on. If several Brainlab applications are installed on the system, select VectorVision osteotomy from the dialog which appears.

When turning the system on, you must wait at least 10 seconds before turning it off again. Otherwise, configuration files and other data on the hard drive may be dam-aged.

Figure 8VectorVision osteotomy Icon

Only authorized Brainlab employees may install software on the navigation station. The user may not install or remove any software.

The selected storage medium (e.g. Zip disk or external USB drive) can be inserted at this point in order to save the patient data, or at the end of the surgery before closing the software. Planning in-formation and screenshots will be saved automatically to the available storage medium on system shutdown.

As software performance can be slowed down when a zip disk is inserted, we recommended insert-ing the Zip disk at the end of the operating procedure, shortly before closing the software program.

Figure 9Storage Medium

Make sure that the Zip disk/external USB drive is correctly labelled (patient name, patient ID, etc.) and not write-protected.

Always store Zip disks and external USB drives in their protective cases when they are not in use.


4.4 Initial Settings

4.4.1 Identifying the Patient

To activate the procedure, the patient’s name and ID are entered using the touchscreen keyboard. All screenshots saved during registration, planning and navigation will be saved to the selected stor-age medium (e.g. Zip disk or external USB drive) using the name defined in this step.

The name of the relevant patient appears on each screenshot. To maintain patient con-fidentiality, ensure that access to screenshots is restricted to the relevant medical per-sonnel.

Figure 10Identification: Patient Name and ID

• Once you have entered the patient’s Name using the keyboard, press the right arrow button next to the space bar to jump to the Id field.

• If required, you can move the cursor back to the Name field using the left arrow button.

• Press Proceed to continue to the next dialog.

• Cancel closes the initial setup procedure.


4.4.2 Defining the Treatment Side

Once the patient’s name and ID is entered, the side to be treated must be now be defined.

Figure 11Treatment Side

• To enter the treatment side simply select Left Knee or Right Knee in the Treatment Side win-dow.

• Press Cancel to exit the initial setup procedure.

• Press Proceed to continue to the next dialog.


4.4.3 Planning the Procedure

In order to plan the procedure, you must define various settings.

Figure 12Osteotomy Options

• In the Osteotomy Options dialog, you are required to select the type of procedure, treatment side, registration method and navigation method. You must select one option for each setting.

• Once you have chosen the required settings, press Proceed to confirm your selection. You will be prompted to begin patient registration as described from Page 45.

• Press Cancel to exit the dialog without saving your selections.

Type of Procedure • You can select the required surgical procedure, Opening Wedge or Closing Wedge.

- The opening wedge procedure allows you to plan the resection plane on the tibia in order to achieve the desired postoperative leg alignment. You can then navigate a cutting block or K-wires to the planned resection plane on the tibia. Finally, the software allows you to adjust the opening of the wedge in order to achieve the planned leg alignment.

- The closing wedge procedure allows you to plan the resection planes for the proximal and distal tibia cuts in order to achieve the desired postoperative leg alignment. You can then nav-igate a cutting block or K-wires to the planned resection plane on the tibia. The software then allows you to close the wedge in order to achieve the planned leg alignment.

• Navigation is described in detail from Page 71 for the opening-wedge procedure and from Page 93 for the closing-wedge procedure.

Treatment Side • You can choose the treatment side, depending on whether there is a varus or a valgus defect:

- If there is a medial defect due to a varus deformity, select Valgisation.

- If there is a lateral defect due a valgus deformity, select Varisation.

Registration Type • You can also decide whether to perform registration with or without arthroscopy.

- By selecting With Arthroscopy, the software allows you to define areas on the bone that are within the knee joint. In this way, the system is able to very accurately calculate the leg geom-etry. Additional steps are required with this registration method.

- If you select Without Arthroscopy, the registered points are acquired directly on the skin over the knee joint. Fewer registration steps are required, compared to registration with arthroscopy, however the leg geometry will not be calculated as accurately.

- Registration is described in detail from Page 45.


Navigation Method • VectorVision osteotomy supports two methods to navigate the resection planes on the tibia.

- By selecting Cutting Block, you can navigate a cutting block to the planned resection plane using a cutting block adapter.

- If you select K-Wires, you can navigate a drill guide to the planned resection plane on the tibia in order to place two K-wires. The K-wires are then used to guide the saw when resect-ing the tibia.

- This setting can also be adjusted at any time during the procedure from the Tools tab in the Toolbox (see Page 38).

Make sure to select the correct treatment side (varisation or valgisation) during initial setup. If you select the incorrect treatment side, all subsequent calculations will be in-accurate.


5 SOFTWARE OVERVIEW5.1 Main Screen

The main screen is automatically opened once initial setup is complete and the patient has been registered (see from Page 45). In the case of VectorVision osteotomy, the Leg Geometry Overview screen will be displayed.

The main screen offers access to all the software functions available in the VectorVision osteotomy software.

• A menu bar is provided on the left side of the main screen and a Close button on the right.

• This default setting can be changed in the Display Setup tab which can be accessed using the System button (see Page 34).

• The rest of the screen shows the selected image display.

Figure 13Main Screen

• You can check navigation accuracy in the Leg Geometry Overview screen at any point during the procedure. Simply touch the pointer to known anatomical landmarks on the bone to make sure the position of the pointer shown on the screen matches the actual location on the bone.

• Pressing the magnifying glass button in each view will display an enlarged version of the selected image. Pressing the magnifying glass will again restore the main screen configuration.


5.2 Menu Bar

The menu bar contains the functions necessary for planning, registration, navigation and system ad-justment. The available functions will vary depending on the selected procedure.

Figure 14Menu Bar (Left: Opening Wedge, Right: Closing Wedge)

• The function that is currently active will be framed in yellow. All other functions are framed in blue.


5.2.1 Camera Displays

Two camera display windows (1) are located at the top of the menu bar. These enable you to check whether the marker spheres on the selected reference array and on the navigated instruments are visible to the cameras.

Figure 15Camera Display

Pressing the camera displays will open the Camera field of view dialog.

Figure 16Camera Field of View

• The boxes top right and left of this dialog show the arrays as detected by the cameras.

• The camera field of view is indicated by the blue cone.

• The position of the reference array and navigated instruments within the camera field of view is indicated by colored spheres within the cone. If these spheres disappear from view, the instru-ment or reference array in question can no longer be tracked.

• The distance of the reference array and navigated instruments from the cameras is shown by rings.

• Press Proceed to exit the camera view and return to the main screen.


Conventions

Tracking Priority Up to five instruments can be simultaneously displayed. The largest array visible takes precedence during navigation.

The software detects instruments based on predefined tool geometries provided by reflective marker arrays. Ambiguous marker sphere constellations may cause the sys-tem to detect a geometry incorrectly.

Red dotsThe marker sphere geometry of the active reference array (if the patient has been registered).

Green dots The marker sphere geometry of the pointer.

Yellow dots The marker sphere geometry of additional reference arrays.

Orange dots The geometrical arrangement of Pointer Angled.

Gray dotsThe marker sphere geometry is visible to both cameras, but cannot be assigned to a tool.

Gray circlesThe marker sphere geometry is only visible to one camera and cannot be interpreted.


5.2.2 Status Fields

The two status fields (2) located at the top of the menu bar beneath the camera displays also indicate whether the selected reference array and the navigated instruments are visible to the cameras.

Figure 17Status Fields

Conventions

Artifacts caused by reflections can cause inaccuracy. Make sure that light sources or items which are highly reflective do not affect the camera’s field of view.

GreenNormal tracking mode. The reference array and navigated instrument must both be visible to the cameras to enable normal tracking mode.

Yellow

If a reference array or instrument is not fully visible to one of the camer-as, the status field will turn yellow and remain so for 5 seconds unless normal tracking resumes. If visibility has still not been reestablished after 5 seconds, the status field will turn red.

RedNo tracking possible. The reference marker spheres are not visible to the cameras.

Black

Camera communication error during startup. If camera communication fails during use, a warning message will appear instead.

If this happens, you may either restart the system or contact Brainlab support.


5.2.3 System Functions

Figure 18System Button

• The System button provides access to a range of system functions.

• You can exit the system functions at any time by pressing Close

Info Press the Info tab to view the Brainlab service numbers and the system version.

Figure 19Info Tab


Settings The Settings tab contains the Sound configuration icon.

Figure 20Settings Tab

This icon opens the Sound dialog where you can adjust the system volume.

Figure 21Sound Configuration

• Sound Output is used to activate or deactivate system sounds, such as error beeps, and other confirmation tones, e.g. when a dialog is opened or closed.

• The volume of system sounds can also be adjusted using the slider bar for approximate adjust-ments, or, for more exact adjustments, using the arrows.

• Button Sound is used to activate or deactivate sound when a button is pressed.

• To apply your settings and exit this dialog, press Close.


Display Setup The Display Setup tab allows the menu bar to be set to the left or right side of the screen.

Figure 22Display Setup Tab

• Select the side on which the menu bar should be displayed.

• The menu bar will now appear on the side of the screen you have chosen.

Patient The Patient tab allows you to transfer patient data from the hard disk to the selected storage medi-um (e.g. Zip disk or external USB drive), and also to delete data that is no longer required.

Figure 23Patient Administration

• To edit a patient file, press the required file in the list.

• To copy a file from the harddrive to the selected storage medium, press Copy.

• To move a file permanently from the harddrive to the selected storage medium, press Move.

• To delete a patient file, press Remove.

• In order to move or remove a patient directory, the corresponding button must be pressed for approximately 2 seconds.


Saved Screenshots The Saved Screenshots tab allows you view all stored screenshots that you have generated during the procedure (see ).

Figure 24Saved Screenshots

• To view a screenshot as a full screen, press the desired image.

• To return to a thumbnail view of all images, press anywhere on the screen.

• The scrollbar on the right side of the page will allow you to scroll up or down through the stored images.


5.2.4 Toolbox Functions

Figure 25Toolbox Button

• The Toolbox button opens the Tools dialog where you can access various functions.

• You can exit the Toolbox at any time by pressing Close.

Tools The Tools dialog provides registration, system accuracy and navigation functions.

Figure 26Tools Tab

• Register Femur/Register Tibia allows you to repeat patient registration if required for the tibia and the femur. Details are provided from Page 54.

• The Add Digitized Points functions enable digitized points to be set on the femur and/or tibia to mark important positions or areas. Details are provided on Page 121.

• The Delete Digitized Points functions allows you to remove digitized points that have been set.

• Osteotomy Options allows you to select the navigation instrument - plane tool or K-wire (see Page 69). You are also prompted to select the required navigation instrument during initial setup (see Page 28).

• Accuracy Check allows you to check navigation accuracy at any point during the procedure. Details are provided on Page 117.


5.2.5 View Management Functions

3D Model

Figure 273D Model Button

The 3D Model button can be used to hide or display the bone model.

Figure 28Main Screen:(Left: with 3D Model, Right: without 3D model)

• Only the points acquired by the user and the calculated bone axes will be displayed.

• Press the 3D Model button to hide the 3D model from view.

• Pressing 3D Model again will show the 3D model again on the screen.

Zoom The Zoom function can be used to enlarge or reduce the size of the displayed image. All image views will be zoomed in or out using the same zoom factor.

Figure 29Zoom Function

• Press the + button to magnify all views to a maximum of 440%.

• Press the - button to reduce all views and reconstructions to a minimum of 8%.

• The percentage at the top of the zoom function will show the current zoom factor.

• Pressing Reset will set the zoom factor back to 200%.


5.2.6 Navigation Functions

The lower section of the menu bar contains the steps necessary for navigation. The available func-tions will depend on the selected procedure.

Figure 30Navigation Functions (Left: Opening Wedge, Right: Closing Wedge)

Set Initial Angle This step allows you to view the leg deformity in extension, and store the preoperative leg alignment. The Set Initial Angle function is described in detail from Page 73 for the opening wedge procedure and from Page 95 for the closing wedge procedure.

Planning You can activate the Planning function once you have stored the preoperative leg alignment. The planning steps allow you to plan the resection plane on the tibia in order to achieve the desired post-operative leg alignment. Planning is described in detail from Page 75 for the opening wedge proce-dure and from Page 98 for the closing wedge procedure.

Cut Navigation If you selected the opening wedge procedure, you can activate the Cut Navigation function once the planning steps have been completed. This step allows you to navigate a cutting block adapter or drill guide to the planned resection plane on the tibia. Cut Navigation is described in detail from Page 86.

Prox. Cut Navigation

This function is available if you selected the closing wedge procedure. You can activate the Prox. Cut Navigation function once the planning steps have been completed in order to navigate a cutting block adapter or drill guide to the planned proximal resection plane on the tibia. This step is de-scribed in detail from Page 106.

Dist. Cut Navigation This function is available if you selected the closing wedge procedure. This step allows you to nav-igate a cutting block adapter or drill guide to the planned distal resection plane on the tibia. The Distal Cutting Plane function is described in detail from Page 109.

Cut Alignment This step allows you to align the resected tibia in order to achieve the planned post-operative leg alignment situation. The Cut Alignment function is described in detail from Page 89 for the opening wedge procedure, and from Page 112 for the closing wedge procedure.


Motion Analysis This is an optional step that allows you to view the leg alignment situation in flexion and extension. Motion analysis can be performed before performing tibia resection and again once the wedge on the resected tibia has been aligned. Motion Analysis is described in detail on Page 115.


5.2.7 Tracking Functions

If you have selected the opening wedge procedure, the FemurArray on Femur and FemurArray on Tibia buttons allow you to switch the Reference Array Y-Geometry, X-Press from the femur to the tibia during the procedure.

Figure 31FemurArray on Femur Button

These buttons are only activated once the resection plane has been planned (see from Page 75).

Femur Array on Tibia

• When FemurArray on Tibia is activated, you can switch the Reference Array Y-Geometry, X-Press from the femur to the proximal part of the tibia. This allows you to track the proximal segment of the tibia relative to the distal segment, once the bone has been resected.

• This step can be performed once the planning steps have been completed, and before you begin navigation of the resection plane (see Page 84).

Femur Array on Femur

• When FemurArray on Femur is activated, you can switch the Reference Array, Y-Geometry, X-Press back to the femur once the tibia has been resected, and the final leg alignment has been achieved. In this way you can track the geometry of the entire leg to view the final leg alignment situation (see Page 91).

• The button that is highlighted yellow indicates the bone to which the reference array is currently attached.

• Pressing the button shown in blue will allow you to attach the reference array to the correspond-ing bone shown on the button.


5.2.8 Information Function

Screenshot

Figure 32Screenshot Button

Pressing the Screenshot button will create a screenshot of the current screen. The screenshot is then stored as an image file, and saved directly to the Screenshot folder on the selected storage medium (e.g. Zip disk or external USB drive).

Figure 33Screenshot Function

• You can view the stored screenshots in the Saved Screenshots tab page by pressing the System button (see Page 37).

The name of the relevant patient appears on each screenshot. To maintain patient con-fidentiality, ensure that access to screenshots is restricted to the relevant medical per-sonnel.


6 REGISTRATION 6.1 Overview

The registration procedure allows important anatomical landmarks to be defined in order to plan and navigate correction of the leg alignment. A 3D model of the patient’s bone is shown. This is created using a database of healthy and arthritic knees. You therefore do not need to scan the patient before beginning intra-operative registration and navigation.

It is important to acquire single landmarks (see Page 48) and directions (see Page 49) as accurately as possible. If these points are incorrectly acquired, the automatically-calculated plan, and as a re-sult, the calculated leg geometry, will be inaccurate. Make sure to remove all osteophytes prior to registration, as these will reduce accuracy.

So that points can be acquired correctly, remove all osteophytes prior to registration.

During registration and navigation, it is important that only the specified pointer is used. The Pointer Angled is used for all VectorVision osteotomy registration steps. The Brainlab Pointer, Sharp Tip is used to define the resection plane on the tibia dur-ing navigation.

To ensure correct registration, the acquired area should be as large as possible.

During the acquisition of landmarks, make sure the tip of the pointer actually touches the bone surface.

When defining points with a medial or lateral orientation, make sure to acquire the cor-rect side as prompted by the software. If a point is acquired incorrectly on the medial or lateral side, the software will display a warning message, and you will need to re-peat acquisition of the relevant points.


6.1.1 Before You Begin

Attaching the Reference Arrays

In order to perform registration and navigation, two reference arrays are attached to the leg to be operated upon:

• Reference array, “Y” geometry

• Reference array, “T” geometry

Details on the available reference arrays are provided from Page 132 for Minimally Invasive Reference Arrays (Y-Design and T-Design), and from Page 137 for Reference Arrays, X-Press(Y-Geometry and T-Geometry).

• The “Y” geometry reference array is attached to the femur and “T” geometry reference array to the tibia. This allows the system to track the location and movement of the two bone segments throughout the entire procedure.

Figure 34Attaching MIRA Reference Arrays

To perform registration, make sure to attach the “Y” geometry reference array to the femur and the “T” geometry reference array to the tibia. The movement of the leg dur-ing the procedure must be taken into consideration when attaching the reference ar-rays to the femur and tibia.

If you have selected the opening wedge procedure (see Page 27), you can detach the ReferenceArray Y-Geometry, X-Press from the femur and attach it to the tibia, proximal to the planned cut. This allows you to track the distal and proximal tibia segments relative to each other once the tibia has been resected. This step can be performed once the planning steps have been completed, and before performing the tibia cut (see Page 84).

In this case, it is useful to mount a third bone fixator to the proximal tibia before beginning the pro-cedure. Make sure to place the Bone Fixator “1-Pin” or “2-Pin”, X-press proximal to the planned tibial cut, and position it in such a way that it will not interfere with the final fixation of the bone.


Figure 35Attaching the Bone Fixator to the Proximal Tibia

You should also take the size of the cutting block into account when placing the reference arrays. Sufficient space should be available to enable incision and drilling without moving the reference ar-rays.

Following tibia resection and final leg alignment, the Reference Array Y-Geometry, X-Press can then be reattached to the femur in order to track the femur and tibia relative to each other (see Page 91).

For details regarding the proper attachment of the Reference Arrays, X-Press to the Bone Fixators, X-Press, see Page 150).

Ensuring Visibility The reference arrays should be positioned side by side, and should both be visible to the cameras at all times during the procedure. Positioning one in front of the other may hinder the camera in dis-tinguishing between the two arrays. You can check whether the reference array geometries overlap in the Camera field of view dialog (see Page 31). To ensure visibility, you can adjust the cameras as required. Make sure that the reference arrays are visible both in flexion and extension. If an ar-throscope is being used, make sure that the reference arrays are not obscured by the optical arthros-copy unit during arthroscopy and registration.

If you have selected the opening wedge procedure and wish to switch the Reference Array Y-Geometry, X-Press to the tibia during navigation, you should also check the visibility of the Reference Array Y-Geometry, X-Press on both the femur and proximal tibia (see Page 47) before beginning registration and navigation. Once the patient is registered, it is no longer possible to adjust the angle of the reference array on the bone fixator.

You must also check the reflectivity of the marker spheres. All instruments must be clearly visible to the system in order to ensure accurate registration. The reflective marker spheres must also be se-curely attached to the pointer during registration.

If you are switching the Reference Array Y-Geometry, X-Press from the tibia to the fe-mur (and vice versa) during the navigation procedure, it is important to not change the position or angle of the reference array using the flexible joints (see Page 150). Other-wise navigation accuracy will be reduced.

Make sure that the position of the reference arrays will not hinder the surgeon’s work, before attaching them to the femur and tibia.

The reflective marker spheres must be tightly secured to the reference arrays so that they will not loosen during surgery.


6.1.2 Registration Methods

Pivoting The first registration method is pivoting. Pivoting involves rotating the femur in a circular manner until a sufficient number of points has been acquired. The software uses pivoting to determine the rota-tional center of the femoral head, which then defines the starting point of the mechanical axis.

Figure 36Pivoting

Single Landmark Acquisition

Single landmarks are registered by holding the tip of the pointer to the relevant bone structure (or soft tissue area covering the bone structure). On the touchscreen, a single arrow indicates where the point should be acquired.

Figure 37Single Landmark Acquisition

• The following points must be acquired using single landmark acquisition:

- Talus (medial and lateral)

- Tibia mechanical axis

- Femur mechanical axis

- Tibia contour (medial and lateral)

- Epicondyles (medial and lateral)

• To confirm registration of the selected point, pivot the pointer.


Acquisition of a Direction

Certain axes and orientations can be registered by holding the pointer in the required alignment.

Figure 38Direction Registration

• The tibial AP direction must be acquired using acquisition of a direction:

• To confirm registration, hold the pointer absolutely still.

• Once the direction has been acquired, the system automatically proceeds to the next registra-tion step.

Multiple Landmark Acquisition

Multiple landmark acquisition is used to register bone areas. Points acquired in this way are used to calculate resection levels. The number of points to be acquired is shown in the center of an acqui-sition clock.

Figure 39Multiple Landmark Acquisition

• The following points must be acquired using multiple landmark acquisition:

- Tibial plateau (medial and lateral)

- Tibial tuberositas

• To begin multiple landmark acquisition, hold the tip of the pointer to the required structure and pivot it slightly.

• Acquire the remaining points by sliding the pointer tip along the defined structure.

• Only points which are at least 2mm from the last acquired point are taken into account.

• Each time a point is acquired, the number shown in the clock is decreased by one, and dots indicating the registered areas will appear on the screen.

• The circular frame inside the clock also indicates the progress of point acquisition. Once all points have been acquired, the clock will show the value zero.


If the tip of the pointer is moved away from the bone, these areas will be acquired as well, reducing registration accuracy. Make sure that the pointer tip is always on the bone during acquisition.


6.1.3 Plausibility Checks

The VectorVision osteotomy software offers integrated plausibility checks which verify:

• That the registration points have been correctly acquired.

• That the reference arrays have been correctly attached.

Medial/Lateral or Left/Right Conflict

If the registered points are incorrect, the following message is displayed:

Figure 40Plausibility Check Failed: Medial Lateral Conflict

• A medial-lateral conflict occurs if you acquire a point on the incorrect side while registering the malleolae (see Page 55), or the medial and lateral tibial contours (see Page 59).

- If you have incorrectly acquired one of these points, press Previous to return to the relevant registration step.

- Pressing Try Again allows the system to detect the reference arrays again.

• A left-right conflict occurs if you define the incorrect treatment side during initial system startup (see Page 26).

- If you have selected the incorrect treatment side, press Cancel and restart the system.


Reference Arrays Additional plausibility checks verify that the appropriate reference arrays for performing registration have been attached to the tibia and femur, and that the reference arrays are visible to the camera.

If the software is unable to properly detect the reference arrays on the tibia or femur, the following message is displayed:

Figure 41Plausibility Check Failed: Reference Arrays

• Make sure the reference arrays are visible to the camera, and that they are attached to the cor-responding bone.

• Pressing Try Again allows the system to detect the reference arrays again.

• Press Proceed to continue registration or press Previous to repeat the previous registration step.

• Press Cancel to restart the system.

If the “Y” or T” geometry reference arrays are not visible to the camera, the software displays a cor-responding warning message:

Figure 42Plausibility Check Failed: Reference Arrays

• Adjust the leg so that both reference arrays are visible to the camera.

• Pressing Try Again allows the system to detect the reference arrays again.

• Press Proceed to continue registration or press Previous to repeat the previous registration step.

• Press Cancel to restart the system.


6.1.4 Registration Type

VectorVision osteotomy allows you to register the patient with or without arthroscopy. You are prompted to select the preferred method of registration during initial setup (see Page 27).

• If you perform registration with arthroscopy, the software allows you to define areas on the intraarticular bone that would otherwise be difficult to reach. In this way, the system is able to very accurately calculate the leg geometry. Additional steps are required with this registration method.

• If you perform registration without arthroscopy, registered points are acquired directly on the skin over the knee joint. Compared to registration with arthroscopy, fewer registration steps are required, however the leg alignment will not be calculated as accurately.

If you are performing registration without arthroscopy, the tibial slope and mechanical axes of the tibia and femur are not calculated based on points acquired directly on the bone. The calculated leg alignment, therefore, will not be as accurate as registration with arthroscopy.

If you select registration with arthroscopy, but are then unable to perform arthrosco-py, you will need to shut the system down and restart the software in order to select registration without arthroscopy.

Standard Registration Steps

The following steps are required for both registration types:

• Hip center calculation (see Page 54)

• Medial and lateral malleolus (see Page 55)

• Medial and lateral tibial contours (see Page 56)

• Tibial AP direction (see Page 57)

• Medial and lateral femoral epicondyles (see Page 58)

• Define Tuberositas (optional, see Page 62)

Additional Registration Steps: with Arthroscopy

If you selected registration with arthroscopy, the following additional steps are performed:

• End point of femoral mechanical axis (see Page 60)

• Start point of tibial mechanical axis (see Page 61)

• Medial and lateral tibial plateaus (optional, see Page 61)

Following registration, the registered points will be indicated by colored dots the bone model.

The medial and lateral tibial plateaus and tuberositas are defined in order to provide the system with additional information about the surface of the bone. These steps, however, are not required to complete registration. If you wish to perform a shorter reg-istration, you can skip these steps by simply pressing Skip in the relevant dialog.


6.2 Registration Steps

6.2.1 Hip Center

The first step of the registration is the calculation of the rotational center of the femur. The rotational center defines the proximal point of the femoral mechanical axis and the start point of the weight bearing axis (Mikulicz line).

Figure 43Femoral Head Calculation

• To calculate the rotational center, rotate the femur in a circular manner. Vary the size of the cir-cular motions to include a combination of small, medium and large circles.

• Make sure that the femur reference array is visible to the camera as the leg is being rotated.

• The software indicates the status of the registration by displaying the percentage of points still to be acquired. 50 points are acquired in total.

• Once the rotational center has been registered, the accuracy is displayed on the screen.

• The following values are possible:

- <1.9mm: This is a very accurate pivoting result. The value is shown for about two seconds and the soft-ware will automatically proceed to the next step.

- 1.9-4.0mm: With an accuracy of up to 4.0mm, the resulting deviation of the femoral mechanical axis is minimal and you can proceed with caution. An accuracy of 4 mm corresponds to a deviation of about 0.6°. You can either press Proceed to continue, or Try Again to repeat hip center calculation.

- > 4.0 mm: The deviation is too great. The Proceed button is disabled and you must try again.

• Cancel will branch you to the Close Program dialog (see Page 123).

To ensure accurate measurement, avoid too much movement of the hip during pivot-ing, and do not change the camera position.


6.2.2 Medial and Lateral Malleolus

With the registration of the malleolae, the navigation system is able to calculate the mid-point of the talus as the distal end point of the tibial mechanical axis. At the same time, the end point of the weight-bearing axis is calculated.

A thicker soft tissue or draping layer around the ankle may vary the result!

Figure 44Defining the Malleolae

• Both the medial and lateral malleolus are defined.

• Simply hold the pointer tip to the prominent malleolar structure and pivot it. It is important to keep the tip of the pointer on the bone.

• Once the system has registered the medial malleolus, the lateral malleolus can be registered in the same way. The system defines the talus midpoint at a distance of 46% from the medial mal-leolus point, and a distance of 54% from the lateral malleolus point.

• The software continues automatically to the next step when the malleolae have been acquired.

• You can also return to the previous dialog using Previous.



6.2.3 Tibial Contours

Defining the contour of the tibia involves two steps. The medial and lateral contours must be identi-fied in order to provide the system with definition of the axis, that along with the mechanical axis, determines the medial proximal tibial angle (MPTA).

If you have selected registration without arthroscopy, the system calculates the midpoint of the tibial plateau as the start point of the tibial mechanical axis.

Figure 45Defining the Contour of the Tibia

• Again, the red arrows will indicate the points to be acquired.

• Simply acquire the most medial and lateral points on the tibia contour using the tip of the pointer. These points should be registered at the level estimated as the tibial resection level.

• The software continues automatically to the next step when the relevant point has been acquired.




6.2.4 Tibial A-P Direction

The A-P direction of the tibia is relevant for the determining the direction of the tibial slope. Definition of the tibial A-P direction also provides the system with information about the orientation of the bone so that the software can correctly calculate the leg geometry. Thus it is extremely important that this step is performed as accurately as possible.

Figure 46Tibial A-P Direction

• The A-P direction of the tibia should be defined exactly parallel to the anterior/posterior direc-tion.

• Hold the pointer to the tuberculum intercondylare, between the anterior and the posterior cruci-ate ligament.

- The medial-lateral pointer direction is relevant, not the proximal-distal direction.

- To define the A-P direction exactly, use the medial 1/3 of the tibial tubercle, the tibial mechan-ical axis point and the posterior cruciate ligament for orientation.

- Any internal or external rotation will lead to inaccurate planning and navigation.

- Make sure that the tip of the pointer is held perfectly still during acquisition.

• If the reference array or pointer are not visible to the camera when defining the tibial A-P direc-tion, a corresponding message will appear in the lower left corner of the dialog. The software will also display a message if the pointer is too far away from the bone.

• The system will automatically continue to the next step once the tibial rotation has been defined.

• Return to the previous dialog using Previous.


It is important to acquire the tibial AP direction as accurately as possible in order to provide the system with correct information about the orientation of the leg. Other-wise, the software will not be able to accurately calculate the required correction.

If it is not possible to hold the pointer directly on the bone (because a surgical approach to the knee joint is not available), hold the pointer to the side of the knee, parallel to the A-P direction. In this case, the software automatically shifts the A-P direction to the center of the knee, once the direction has been calibrated.


6.2.5 Femoral Epicondyles

The next step is the definition of the medial and lateral epicondylar points. These landmarks define the epicondylar axis, the reference for the femoral rotation.

Figure 47Epicondyles

• To register these points, hold the tip of the pointer to the most medial point of the medial epicon-dyle.

• The system will automatically proceed to the next step once the epicondyles have been defined.




6.2.6 Additional Registration Steps With Arthroscopy

If you have selected registration with arthroscopy, you are now prompted to perform three additional steps:

• Definition of the femoral mechanical axis

• Definition of the tibial mechanical axis

• Definition of the medial and lateral tibial contours

The following dialog appears prompting you to first prepare the arthroscopy equipment:

Figure 48Prepare Arthroscopy Equipment

• The software will automatically proceed to definition of the femoral mechanical axis (see Page 60) after 15 seconds.

• You can also press Proceed to resume registration.


Femoral Mechanical Axis

The definition of the femoral mechanical axis is necessary in order to determine the varus/valgus and the flexion/extension alignment of the femur. This in turn affects the overall leg alignment. Thus, it is important that the mechanical axis point is acquired as accurately as possible.

Figure 49Femoral Mechanical Axis

• Using the tip of the pointer, acquire the point indicated by the red arrow.

• This point defines the distal end of the femoral mechanical axis, i.e. the location where the intra-medullary drill or reamer is normally inserted during non-navigated total knee procedures.

• The system will automatically proceed to the next step once the femoral mechanical axis has been defined.




Tibial Mechanical Axis

The mechanical axis serves as the basis for all further calculations (varus/valgus, tibial posterior slope, etc.). In order to achieve a good planning result, the mechanical axis point must therefore be acquired as accurately as possible.

Figure 50Tibial Mechanical Axis

• Using the tip of the pointer, register the beginning of the anterior cruciate ligament at the ante-rior part of the eminentia intercondylaris (as shown by the red arrow). Make sure that you acquire the point which defines the mechanical axis and not the eminence.

• The system will automatically continue to the next step once the mechanical axis has been defined.



Tibial Plateau Both the medial and the lateral plateaus are defined for the tibia. The points acquired in this step are used to register the tibial slope. During planning, the software then aligns the cutting plane parallel to the tibial slope. In the final alignment step, the software allows you to compare the achieved tibial slope relative to the preoperatively defined slope.

Figure 51Definition of the Tibia Plateaus

• You must acquire 30 points on the medial and the lateral tibia plateau.

• The start point should be acquired by pivoting the pointer in the center of the medial and lateral plateaus, as indicated by the red arrow in the dialog.

• Dots will appear on the screen each time a point is acquired. The amount of points still to be acquired is shown on the screen.

• The system will automatically continue to the next step once the tibial plateau has been defined.

• If point acquisition is inaccurate, press Try Again.


• If you do not wish to perform this step (see Page 53), you can also press Skip.



6.2.7 Tibial Tuberositas

Definition of the tuberositas is the final registration step, and can be performed with or without ar-throscopy. This step provides the system with information about the location of the tuberositas. The surgeon can then avoid this area, when planning the tibial cut or when performing a biplanar oste-otomy. It is important to acquire the entire tuberositas in order to provide the system with accurate information about this area.

Figure 52Define Tuberositas

• You must acquire 50 points on the tibia tuberositas.

• The start point should be acquired by pivoting the pointer on the tuberositas as indicated by the green area on the bone model.

• Dots will appear on the screen each time a point is acquired. The amount of points still to be acquired is shown on the screen.

• The system will automatically continue to the next step once the tibia tuberositas has been defined.

• If point acquisition is inaccurate, press Try Again.


• If you do not wish to perform this step (see Page 53), you can also press Skip.



6.2.8 Accuracy Check Points

Once all required registration points have been acquired, you are prompted to acquire accuracy checkpoints. Accuracy check points allow you to verify navigation accuracy during the procedure.

One point is defined on the femur and one on the tibia. The software will calculate the points you define and display them on the bone model.

Make sure to define a point that is not going to be resected during surgery. It is recommended to mark the point on the bone before defining it, in order to easily find the landmark again.

• You will first be prompted to select a point on the tibia, distal to the estimated resection plane:

Figure 53Define Accuracy Checkpoint: Tibia

• The bone is displayed in three image views on the screen. The center view of the dialog allows you to track the movement of the pointer.

• Select the desired landmark on the tibia and pivot the pointer.

• Pressing Previous will return you to the previous registration step.


• You are now prompted to choose a point on the femur.


Figure 54Define Accuracy Checkpoint: Femur

• Pivot the pointer on the desired area on the femur.

• You can use the incision for the reference array “Y” geometry to define a point directly on the bone if a surgical approach to the femur is not available.

• Pressing Previous will return you to the Accuracy Check Point dialog for the tibia.


• When an accuracy check point for the tibia has been defined, you can begin navigation.

During navigation, the software will prompt you every 30 minutes to verify the check points. In this way, you can see whether there is any deviation from the registration accuracy (see Page 68).


7 NAVIGATION OVERVIEW7.1 Before You Begin

The navigation functions are activated once registration has been completed (see from Page 45). Depending on which procedure has been selected (see Page 27), corresponding navigation func-tions are available.


7.1.1 Intraoperative Tracking

Reference Arrays Before you begin, make sure that the “Y” geometry and “T” geometry reference arrays are attached to the correct bone.

• If you are performing closing wedge osteotomy, the “Y” geometry reference array is attached to the femur and the “T” geometry reference array is attached to the tibia throughout the proce-dure.

• If you are performing opening wedge osteotomy (see from Page 71), the Reference Array Y-Geometry, X-Press can be detached from the femur and attached to the tibia once planning has been completed (see Page 84). Once the tibia is resected, and final wedge alignment has been completed, the Reference Array Y-Geometry, X-Press can be reattached to the femur (see Page 91) to track femur relative to the tibia.

If the arrays move or become unstable, verify the accuracy and attach again if necessary. If the ac-curacy decreases or if a reference array must be attached again, you will have to repeat registration before proceeding to navigation.

Make sure to attach the reference arrays to the correct bone. The Reference Array T-Geometry, X-Press is attached to the tibia, and the Reference Array Y-Geometry, X-Press is attached to the femur. After registration and planning, the Reference Array Y-Geometry, X-Press can then be attached to the proximal tibia (opening wedge proce-dure only). The movement of the leg during the procedure must be taken into consid-eration when attaching the reference arrays to the femur and tibia.

Do not move the reference marker array relative to the patient’s anatomy during the procedure. Any movement may affect the entire measurement coordinate system, leading to incorrect instrument display and injury to the patient.


Instrument Adapters

During the procedure, navigated instruments equipped with reflective marker spheres are used to guide the instrument to the planned resection plane. The results are displayed on the VectorVisiontouchscreen. Details on the available adapters are provided from Page 167.

To ensure that the instruments are visible at all times, make sure that the camera is well positioned. If the geometry of the instrument cannot be identified, check the marker spheres to ensure they are clean and undamaged. Also check the reference arrays to ensure they are not bent.

During the navigation procedure, you should regularly check that the required accuracy level is maintained. To do so, hold the pointer to predefined checkpoints on the femur and tibia, and check the deviation to the originally acquired points (see Page 118).

To ensure accurate registration and navigation, the cameras must have an unob-structed view of the instrument marker spheres at all times.


7.1.2 Available Workflows

In order to perform tibial osteotomy, VectorVision osteotomy supports the opening and closing wedge procedures. You are prompted to select the required procedure during initial setup (see Page 27).

If you have selected opening wedge osteotomy, you can also decide whether to navigate the entire procedure, or whether you would like to navigate leg alignment only (see Page 15).

The table shown below displays the steps required for the available workflows:

Optional

Optional Optional

Optional Optional Optional

• If you are navigating leg alignment only, or if you do not wish to perform the optional steps, you can simply skip the corresponding step in the workflow.

• The navigation steps are described in detail from Page 71 for the opening-wedge procedure and from Page 93 for the closing-wedge procedure.

Navigation StepsOpen ing Wedge

C los ing Wedge

Standard Procedure

Navigating Leg Alignment Only

Define initial leg geometry

Define end point of resection plane

Define start point of resection plane

Adjust center of rotation

Fine-tune resection plane

Define leg alignment

Move “Y” geometry reference array to distal tibia

Navigate resection plane(Proximal and distal)

Cut alignment

Move “Y” geometry reference array to femur (optional)

Motion analysis


7.1.3 Navigation Tools

Depending on the navigation method you select, various Brainlab navigation instruments may be re-quired during surgery.

Standard Instruments

• Brainlab Pointer, Sharp Tip (see Page 130)

• Pointer Angled (see Page 131)

• Reference array, “Y” geometry

• Reference array, “T” geometry

Details on the available reference arrays are provided from Page 132 for Minimally Invasive Reference Arrays (Y-Design and T-Design), and from Page 137 for Reference Arrays, X-Press(Y-Geometry and T-Geometry).

Navigation Method Specific Instruments

• Drill Guide (see Page 152)

- The drill guide is used to navigate two K-wires to the planned resection plane in order to place K-Wires. The K-wires are then used to guide the saw when resecting the tibia.

• Femoral and Tibial Cutting Block Adapter (see Page 157)

You can select the instrument to be navigated from the Toolbox at any point during the procedure.

• To select the required instrument, select Osteotomy Options button in the Tools tab.

The Osteotomy Options dialog is displayed:

Figure 55Select Navigation Tool

• Simply select the tool to be navigated, Cutting Block or K-Wires, and press Proceed to apply your selection.

• You are also prompted to select the required tool during initial setup (see Page 28).


8 NAVIGATION: OPENING WEDGE

8.1 Method

The opening wedge procedure allows you to first plan the resection plane on the tibia, and then plan the wedge angle required to correct the leg alignment to the desired postoperative values. You can then navigate a cutting block or K-wires to the planned resection plane. Once the tibia has been re-sected, the software allows you to adjust the opening of the wedge in order to achieve the planned leg alignment.

VectorVision osteotomy also allows you to navigate leg alignment only, without navigating the tibia resection plane (see Page 15). In this case, you can skip the steps in the workflow that are not re-quired.


8.2 Navigation Steps

The navigation functions are provided in the lower section of the menu bar.

Figure 56Menu Bar: Opening Wedge

• The navigation steps for the opening wedge procedure are carried out in the following order:

- Define the initial leg alignment (see Page 73)

- Define the cutting plane end point (optional, see Page 77)

- Define the cutting plane start point (optional, see )

- Adjust the center of rotation (see Page 79)

- Fine-tune the tibia cutting plane (see Page 81)

- Plan leg alignment (see Page 83)

- Attach the Reference Array Y-Geometry, X-Press to the proximal tibia (optional, see Page 84)

- Navigate the tibia cutting plane (see Page 86)

- Adjust the wedge to achieve final leg alignment (see Page 89)

- Attach the Reference Array Y-Geometry, X-Press to the femur (optional, see Page 91)

- Perform motion analysis (optional, see Page 92)

• If you are performing the opening wedge procedure and navigating leg alignment only (see Page 15), navigation is carried out as follows:



- Fine-tune the tibia cutting plane (see Page 81)

- Plan leg alignment (see Page 83)

- Adjust the wedge to achieve final leg alignment (see Page 89)



8.2.1 Defining the Initial Leg Alignment

This function allows you view the leg deformity in extension and store the preoperative leg align-ment. The values you store here will be used in the subsequent planning steps to calculate the re-quired angle of the wedge opening in order to achieve the desired leg alignment.

• The Leg Geometry Overview screen is automatically opened once patient registration has been completed. You can also activate initial leg alignment by selecting Set Initial Angle from the menu bar.

Figure 57Set Initial Angle

Setting the Initial Angle

The Leg Geometry Overview screen shows the current leg alignment situation in extension.

Figure 58Initial Angle Definition Screen

• Hold the leg in extension to view the preoperative malalignment.

- In the left view, the software indicates whether the leg is in varus or valgus, and displays the angular value below the arrow.

- In the right view, the arrow indicates the current flexion/extension angle of the leg, and dis-plays the value below the arrow.

- The internal-external rotation of the tibia relative to the femur is shown at the bottom of the right view.

• To store the preoperative leg alignment, hold the leg in full extension and press the record but-ton at the bottom of the left view.

- In order to store the initial alignment, the flexion angle can be no greater than 20°. If the angle is greater than 20°, the record button will disappear.

• Once you have recorded the leg alignment, the software will display a warning message if:

- you have selected a Varisation correction during initial setup (see Page 27), and the recorded leg alignment shows the leg is already in varus,

- you have selected a Valgisation correction during initial setup (see also Page 27), and the recorded leg alignment shows the leg is already in valgus.


Figure 59Varisation/Valgisation Warning

• If the selected treatment side is correct, press Accept to proceed to the confirmation of the ini-tial leg alignment values.

• If you would like to change the treatment side, press Cancel and restart the system.

Confirming the Initial Angle

Once the leg alignment has been stored, the software displays the recorded values.

Figure 60Confirm Initial Alignment

• The following information is stored:


- Medial-proximal-tibia angle (MPTA)

- Extension/flexion angle

- Length of hip-ankle line (H/A Length)

- Internal/external rotation of the tibia relative to the femur

- The intersection point between the mechanical axis and the tibial joint-line axis is displayed at the bottom of the image view. The intersection point is displayed as a blue sphere on the tibia.

• Information on how these values are calculated is provided from Page 16.

• The Zoom function can be used to enlarge or reduce the size of the displayed image.

• Press Apply to confirm the initial leg alignment values, and return to the leg alignment screen.

• Cancel exits the procedure, without saving the values.


8.2.2 Planning the Resection Plane

Once the initial leg alignment has been recorded, you can plan the resection plane on the tibia.

• The planning steps are activated by selecting Planning from the menu bar.

• Planning the resection plane is comprised of the following steps:

- Defining the cutting plane end point (on the contralateral cortex, optional)

- Defining the cutting plane start point (optional)

- Adjusting the center of rotation

- Fine-tuning the resection plane

- Aligning the leg based on the planned resection

Planning Options The software also allows you to skip definition of the resection plane end point and start point if:

• you wish to navigate leg alignment only without navigating the resection plane,

• you would like to navigate the tibial resection plane, but prefer more manual adjustment options.

You can also choose to skip definition of the start point only. Depending on how you define the re-section plane, various adjustment functions are available to manually position the center of rotation (see Page 80) and fine-tune the resection plane (see Page 82).

The table below provides an overview of the available adjustment functions, depending on the meth-od used to define the resection plane

Table 1: Adjustment Possibilities

• Medial-lateral • Anterior-posterior rotation

• Medial-lateral

• Anterior-posterior

• Proximal-distal

• Anterior-posterior rotation

• Medial-lateral rotation

• Medial-lateral


• Proximal-distal



• Proximal-distal

.

• If you choose to skip definition of the cutting plane end point and/or start point, the system will not have information about the resection plane on the actual bone. The additional adjustment steps provide the system with information in order to more accurately display movement of the leg on the navigation screen. Make sure to position the center of rotation and resection plane as accurately as possible to match the anticipated location on the actual bone.

Definition of Resection Plane

Adjustment Options: Center of Rotation

Adjustment Options: Finetune Resection Plane

Define end point and start point

Define end point only

Skip definition of resection plane


If you decided to skip definition of the resection plane end point and/or start point, the system will not have as much information about the actual position of the center of rotation or the resection plane on the bone. Therefore, you should make sure to posi-tion the center of rotation as accurately as possible to match the estimated position on the actual bone when performing manual adjustments.

NOTE:

• If you inadvertently press the Planning button in the menu bar after planning has been com-pleted, simply press Cancel to return to the main screen. As long as you do not define another cutting plane end point, the previous planning information will be saved.

• If you define the cutting plane end point again and then press Cancel in this step, all previous planning information will be lost. In this case, all planning steps will need to be repeated.


Defining the Resection Plane

You are first required to define a point on the surface of the tibia, on the side where the cutting plane will end. The system will use the point you acquire here as the reference to determine the initial cen-ter of rotation point on the tibia.

Figure 61Define Tibial Cutting Plane End Point

• Using the Brainlab Pointer, Sharp Tip you must define a single point at the desired resection level on the medial or lateral tibia.

- If there is a medial defect, the end point of the cutting plane is defined on the lateral side of the tibia.

- If there is a lateral defect, the end point of the cutting plane is defined on the medial side of the tibia.

• Using the sharp tip of the pointer, penetrate the skin at the required location, and pivot the pointer on the bone.

• The software will calculate the point and automatically proceed to the next step.

• If you are navigating leg alignment only (see Page 15) or if you wish to manually define the cen-ter of rotation and resection plane, simply press Skip. You will be prompted directly to adjust the center of rotation (see Page 79).

• Cancel closes the planning procedure without saving your changes.


You are now prompted to acquire a second point on the surface of the tibia, on the side where your surgical approach will begin.

Figure 62Define Tibial Cutting Plane Start Point

• Using the Brainlab Pointer, Sharp Tip, define a single point at the desired resection level, on the medial or lateral tibia.

- If there is a medial defect, the start point of the cutting plane is defined on the medial side of the tibia.

- If there is a lateral defect, the start point of the cutting plane is defined on the lateral side of the tibia.

• Using the sharp tip of the pointer, penetrate the skin at the required location (if the initial incision has not already been made), and pivot the pointer on the bone.


• If you wish to manually define the center of rotation and resection plane, simply press Skip. You will be prompted directly to adjust the center of rotation (see Page 79).

• Pressing Previous returns you to the previous planning step.



Adjusting the Center of Rotation

The cutting plane end point is the reference for the initial position of the center of rotation (the “hinge” from which the wedge is opened and the point at which the distal tibia can be rotated relative to the proximal tibia). The software automatically places the center of rotation 5mm toward the center of the knee, from the point you defined as the cutting plane end point (see Page 77).

• In this step, you can adjust the center of rotation to the desired point on the tibial joint-line axis where the resection plane should end. This allows you to determine the depth of the cut, and at the same time, define how much bone will remain unresected.

Figure 63Adjust Center of Rotation

• The tibia is shown in coronal and sagittal views on the screen. The software displays the follow-ing information:

- In the left view, the end point and start point of the cutting plane are indicated by small red spheres.

- The center of rotation is indicated by a large red sphere.

- The software displays the distance between the center of rotation and the start point of the resection plane. This value indicates the depth of the planned cut.

• Using the medial-lateral function buttons at the bottom of the screen, you can adjust the center of rotation on the resection plane to the desired point on the bone where the resection plane should end. The amount of adjustment in millimeters is shown above the arrow buttons.

- The adjusted position center of rotation is shown on the tibia. The software will also recalcu-late and display the length of the cut, based on the adjusted position.

- The Default button sets the point back to the default position defined by the software.

• Press Apply to confirm the center of rotation.



The center of rotation point should be defined as accurately as possible. If there is a deviation of a few millimeters between the actual and planned point, the movement of the displayed bone model will not be as accurate.

Additional Adjustment Functions:

The system does not have as much information about the resection plane on the bone if you decided to skip definition of the cutting plane end point (see Page 77) and/or start point (see Page 78). Ad-ditional adjustment functions are then automatically displayed in the Adjust Center of Rotation di-alog.


These adjustments allow the system to more accurately display movement of the leg on the naviga-tion screen. Make sure to match the center of rotation as accurately as possible to the position on the bone where you anticipate actual center of rotation will be.

• In this case, the following adjustment functions are available:

Figure 64Additional Adjustment Functions

• Using the Prox/Dist buttons, you can adjust the proximal-distal position of the center of rotation to the level of the estimated resection. The amount of adjustment in millimeters is displayed above the buttons.

• Using the Ant/Post buttons, you can adjust the anterior-posterior position of the center of rota-tion.

• The Default buttons will set the point back to the originally defined position.

If you decided to skip definition of the resection plane end point and/or start point, the system will not have as much information about the actual position of the center of rotation or the resection plane on the bone. Therefore, you should make sure to posi-tion the center of rotation as accurately as possible to match the estimated position on the actual bone.

When adjusting the center of rotation, make sure to position the point inside the bone.


Finetuning the Tibia Cutting Plane

Once the center of rotation has been defined, the planned resection plane is displayed as a yellow plane on the tibia. The fine-tuning step allows you to adjust the anterior/posterior position of the cut-ting plane.

Figure 65Finetune Tibia Cutting Plane

• The software has positioned the resection plane according to the defined center of rotation and start point of the sawing plane.

- If you registered the patient using arthroscopy, the software places the planned resection plane parallel to the tibial plateau, based on the points you acquired on the plateaus during registration (see Page 61).

- If you registered the patient without arthroscopy, the software places the planned resection plane perpendicular to the mechanical axis.

• Using the anterior-posterior buttons at the bottom of the dialog, you can adjust anterior-poste-rior rotation of the cutting plane. The adjusted angle of rotation is then displayed above the but-tons.

- The Default button will set the rotation back to the original position (parallel to the tibial pla-teau, or perpendicular to the mechanical axis).

• Press Apply to accept the planned resection plane, and proceed to the next step.


• Cancel exits the planning procedure without saving your changes.



The system does not have as much information about the resection plane on the bone if you decided to skip definition of the cutting plane start point (see Page 78), or if you would like to navigate leg alignment only (see Page 15). Additional adjustment functions are then automatically displayed in the Finetune Tibia Cutting Plane dialog.

These adjustments allow the system to more accurately display movement of the leg on the naviga-tion screen. Make sure to position the resection plane as accurately as possible to the position on the bone where you anticipate actual cut will be.

• In this case, the varus/valgus adjustment function is shown:

Figure 66Additional Adjustment Functions: Varus Valgus

• Using the arrow buttons, you can rotate the varus/valgus position of the cutting plane around the defined center of rotation. The adjusted angle of rotation is then displayed above the but-tons.

• The Default button will set the rotation back to 0°.

If you are navigating leg alignment only, a height adjustment function is automatically displayed al-lowing you to adjust the resection level.

- The height adjustment function is shown in the Finetune Tibia Cutting Plane dialog if you skip definition of the cutting plane end point (see Page 77).

Figure 67Additional Adjustment Functions: Height

• The software positions the level of the resection according to the proximal-distal position of the center of rotation you defined (see Page 79).

• Using the arrow buttons, you should match the resection plane as accurately as possible to the position on the bone where you anticipate the actual cut will be placed.

• Each time you press the button, the resection level is adjusted by 1mm.

• The Default button will set the height back to the level originally defined by the center of rota-tion.

If you decided to skip definition of the resection plane end point and/or start point, the system will not have as much information about the actual position of the center of rotation or the resection plane on the bone. Therefore, you should make sure position the resection plane as accurately as possible to match the estimated position on the actual bone.


Leg Alignment This step allows you to adjust the distal tibial segment relative to the proximal tibial segment in order to achieve the desired leg alignment. The software displays important values that are updated in real time according to the adjustments you make to the planned wedge alignment.

Figure 68Leg Alignment

• On the right side of the screen, the software displays the preoperative leg alignment values you stored during initial leg alignment (see Page 73).

• In the image view on the left, the tibia is shown already resected. The software uses the initial leg alignment values you stored (see Page 74), and the planned resection plane to automati-cally align the wedge to achieve the following values:

- With a medial defect, the software aligns the leg so that the mechanical axis intersects the tib-ial plateau at 62% of the total medial-lateral tibial diameter (measured from the lateral side).

- With a lateral defect, the software aligns the leg so that the mechanical axis intersects the tib-ial plateau at 38% of the total medial-lateral tibial diameter (measured from the lateral side).

- The intersection point is indicated by the blue sphere on the bone.

• In the left view, the software also shows the varus/valgus and medial-proximal tibial (MPTA) angles based on the currently planned wedge alignment.

• The hip-ankle line length is displayed. The difference in millimeters between the current leg length and preoperative leg length is displayed below the total value.

• Using the arrow buttons on each side of the bone image, you can rotate the distal tibia, relative to the proximal tibia in order to adjust the wedge opening.

- Each time you press the buttons, the intersection of the tibial joint-line axis and mechanical axis is adjusted by 1%. The leg length, varus/valgus and medial-proximal-tibial angles will be adjusted accordingly, and displayed in the image view.

• You can also adjust the varus/valgus angle of the leg using the Var/Val function buttons. Each time you press this button, the varus/valgus position is adjusted by 1°. The adjusted angle is then displayed above the buttons.

- The Reset button will set the varus/valgus angle back to the originally planned position.

• Press Apply to accept the leg alignment values. This will update the plan, and all subsequent steps will be based on these values.


• Cancel exits the procedure without saving the adjustments.


8.2.3 Attaching the Reference Array to the Tibia

Once the planning steps have been completed, you now have the option of removing the Reference Array Y-Geometry, X-Press from the femur and attaching it to the tibia, proximal to the planned cut. This allows the software to track the proximal and distal tibia segments relative to each other after the bone has been resected.

Note: Although it is not required, we recommend performing this step in order to optimally track the alignment of the resected tibia. Otherwise the software will continue to track the femur relative to the tibia, and movement of the leg will not be displayed as accurately on the screen.

• To change the reference array, select FemurArray on Tibia from the menu bar.

Figure 69Femur Array on Femur button

Attaching the Reference Array

In the following dialog you are now prompted to switch the Reference Array, Y-Geometry, X-Pressfrom the femur to the tibia:

Figure 70Change Reference Array to Tibia

• You can now remove the reference array from the femur and attach it to the proximal segment of the tibia.

- For details regarding the proper attachment of the Reference Arrays, X-Press to the Bone Fixators, X-Press, see Page 150.

• If the software is unable to track the “Y” or T” geometry reference arrays, a corresponding mes-sage is displayed. Adjust the leg so that both reference arrays are visible to the camera.

• Once the Reference Array, Y-Geometry, X-Press is correctly attached to the tibia, press Pro-ceed. The software will now track the reference array on the tibia, and the femur will be dis-played in blue, indicating that it is no longer being tracked.

• To exit the dialog without changing the reference array, press Cancel.

Note: In the menu bar, the Planning and Motion Analysis buttons are no longer displayed, as these functions can only be performed by taking into account the geometry of the entire leg.


Defining an Accuracy Checkpoint

Once you have attached the Reference Array, Y-Geometry, X-Press to the tibia, the software prompts you to acquire an accuracy checkpoint on the proximal tibia.

Figure 71Define Accuracy Checkpoint: Proximal Tibia

• Pivot the pointer on the desired area on the tibia, proximal to the planned cut.

• When an accuracy check point for the tibia has been defined, you can begin navigation.

While the Reference Array Y-Geometry, X-Press is attached to the tibia, the software will prompt you every 30 minutes to verify the check point on the proximal tibia (see Page 119). In this way, you can see whether there is any deviation from the registration accuracy.

It is important to switch the Reference Array Y-Geometry, X-Press to the proximal tibia in order to track the proximal tibial relative to the distal tibia when aligning the leg. Otherwise, movement of the leg will not be accurately displayed on the screen. By switching the Reference Array Y-Geometry, X-Press to the proximal tibia, the software can more accurately display movement of the bone model.


8.2.4 Navigating the Tibia Resection Plane

Once the planning of the tibial resection plane has been completed, you can navigate the resection plane using either a cutting block adapter or a drill guide.

NOTE: If you are navigating leg alignment only (see Page 15), this step is not required. In this case, you can resect the tibia without navigation according to standard surgical procedure, and pro-ceed directly to Cut Alignment (see Page 89).

• You are prompted to select the required navigation method when completing your initial settings (see from Page 27). This setting can also be adjusted at any time from the Osteotomy Options button in the Toolbox.

• Navigation of the resection plane is activated by selecting Cut Navigation from the menu bar.

Figure 72Cut Navigation Button

Navigation with the Cutting Block Adapter

If you are navigating with a cutting block adapter, the system will detect the instrument and display it as a blue plane indicating the current position of the cutting block.

Figure 73Navigation with the Cutting Block Adapter

• The arrows indicate the direction in which you should move the cutting block to achieve the planned position. The values under the arrows will be zero when the actual plane is aligned with the planned plane.

• The proximal/distal position and varus/valgus angle of the cutting block relative to the planned resection plane is shown in the left image view. In the right view, the software also shows the tibial slope relative to the planned resection plane.

• If you defined a cutting plane start point (see Page 78), the depth of the planned cut, (the dis-tance between the start point and the center of rotation) is displayed in the right view.

• Match the current position (blue plane) as accurately as possible to the planned position (yellow plane) and secure the cutting block.

You can now perform the tibial resection according to standard surgical procedure.


Navigation with K-Wires

If you are navigating K-wires, the system will detect the drill guide and display a blue plane indicating the current position of the K-wire. The K-wire is indicated as a red line extending from the navigated tool.

Figure 74Navigation with K-Wires

• The arrows indicate the direction in which you should move the drill guide to achieve the planned position. The values under the arrows will be zero when the actual plane is aligned with the planned plane.

- The proximal/distal position and varus/valgus angle of the navigated tool relative to the planned resection plane is shown in the left image view. In the lower right view, the software also shows the tibial slope relative to the planned resection plane.

- In the upper right view, an axial view of the tibia is displayed. This view shows the anterior-posterior position of the K-wire on the tibia.

- If you defined a cutting plane start point (see Page 78), the depth of the planned cut, (the dis-tance between the start point and the center of rotation) is displayed in the right view.

• Match the current position (blue plane) as accurately as possible to the planned position (yellow plane) and drill the first K-wire according to standard surgical procedure.

• Once the first K-wire has been drilled, press the record button. This allows you to record the position of the first K-wire according to the position of the drill guide.


Figure 75Calibrate Drill Guide Direction

• The system will automatically recognize the reference array and the geometry of the drill guide.

• Cancel closes the update procedure without changing the plan.

• To enable calibration, hold the drill guide still over the K-wire and wait two seconds. The system will calculate the position of the k wire and update the plan accordingly.

• The software now displays the navigation screen with the drilled K-wire indicated by a blue line on the tibia.

Figure 76Navigation Screen: Navigate Second K-Wire

• Using the drill guide, you can now navigate the second K-wire to the correct position. The upper right view allows you to align the second K-wire parallel to the first K-wire, without intersecting the two wires.

• Once the second K-wire is drilled, tibial resection can be performed according to standard surgi-cal procedure.


8.2.5 Opening Wedge Alignment

Once the tibia has been resected, you can align the resected tibia to achieve the planned leg align-ment.

• This function is activated by selecting Cut Alignment from the menu bar.

Figure 77Cut Alignment Button

The Open Wedge Alignment screen is displayed.

Figure 78Opening Wedge Alignment


• In the left view, the software displays the following information based on the current leg align-ment:

- the varus/valgus angle

- the intersection point of the mechanical axis and the tibial joint-line axis

- the actual length of the hip-ankle line. The difference in millimeters between the current leg length and preoperative leg length is displayed below the total value.

- the medial-proximal tibial angle (MPTA)

• The upper right view displays the internal/external rotation of the tibia relative to the femur.

- The yellow dotted line indicates the A/P direction of the femur.

- The red dotted line indicates the A/P direction of the tibia.

- The arrow indicates the direction in which to adjust the leg to match the planned internal-external rotation. The value under the arrow will be 0° when the planned rotation has been achieved.

• The lower right view displays the current flexion/extension position of the proximal tibia relative to the distal tibia. The arrow indicates the direction in which to adjust the wedge to match the actual tibial slope to the to the preoperatively defined slope (based on the registered points). The value under the arrow will be 0° when the current slope matches the preoperative angle.

• Open the wedge by adjusting the distal tibial segment. Match the actual position of the mechan-ical axis (indicated by the blue sphere) to the planned position of the mechanical axis (indicated by the yellow sphere).

• Once the final leg alignment has been determined, you can now fix the leg with e.g. a plate, according to standard surgical procedure.


8.2.6 Attaching the Reference Array to the Femur

Once final leg alignment has been completed, you can now reattach the Reference Array Y-Geometry, X-Press to the femur. This allows you to track the geometry of the entire leg to ensure the desired post-operative leg alignment has been achieved, based on the current wedge opening.

• To change the reference array, select FemurArray on Femur from the menu bar.

Figure 79Femur Array on Femur button

In the following dialog you are now prompted to switch the Reference Array, Y-Geometry, X-Pressfrom the tibia to the femur:

Figure 80Change Reference Array to Femur

• You can now remove the reference array from the tibia and attach it to the femur.

- For details regarding the proper attachment of the Reference Arrays, X-Press to the Bone Fixators, X-Press, see Page 150.

• Once the Reference Array, Y-Geometry, X-Press is correctly attached to the femur, pressProceed. The software will now track the reference array on the femur, and the femur will be displayed in white, indicating that it is being tracked by the software.

• Pressing Previous returns you to the previous step.

• To exit the dialog without changing the reference array, press Cancel.


8.2.7 Motion Analysis

Motion Analysis is an optional function that allows you to check the final leg alignment once the resected tibia has been aligned and the bone secured.

Note: The Reference Array, Y-Geometry, X-Press must be attached to the femur (see Page 91) before performing motion analysis.

• This function is activated by selecting Motion Analysis from the menu bar.

Figure 81Motion Analysis Button

Motion Analysis is described in detail from Page 115.


9 NAVIGATION: CLOSING WEDGE

9.1 Method

The closing wedge procedure allows you to plan the proximal and distal resection planes on the tibia. The required wedge angle is planned in order to correct the leg alignment to the desired postoper-ative values. You can then navigate a cutting block or K-wires to the planned resection planes. Once the tibia has been resected, you can close the wedge in order to achieve the planned leg alignment.


9.2 Navigation Steps

The navigation functions are provided in the lower section of the menu bar.

Figure 82Menu Bar: Closing Wedge

• The navigation steps are carried out in the following order:


- Define the end point of the proximal cutting plane (see Page 99)

- Define the start point of the proximal cutting plane (optional, see )


- Fine-tune the proximal tibial cutting plane (see Page 103)

- Plan leg alignment by adjusting the distal tibia resection plane (see Page 104

- Navigate the proximal tibia cutting plane (see from Page 104)

- Navigate the distal tibia resection plane (see from Page 109)

- Close the wedge to align the resected tibia (see Page 112)



9.2.1 Defining the Initial Leg Alignment

This function allows you view the leg deformity in extension and store the preoperative leg align-ment. The values you store here will be used in the subsequent planning steps to calculate the amount of correction required in order to achieve the desired leg alignment.

• The Leg Geometry Overview screen is automatically opened once patient registration has been completed. You can also activate initial leg alignment by selecting the Set Initial Anglebutton from the menu bar.

Figure 83Set Initial Angle

Setting the Initial Angle

The Leg Geometry Overview screen shows the current leg alignment situation in extension.

Figure 84Initial Angle Definition Screen

• Hold the leg in extension to view the preoperative malalignment.

- In the left view, the software indicates whether the leg is in varus or valgus, and displays the angular value below the arrow.

- In the right view, the arrow indicates the current flexion/extension angle of the leg, and dis-plays the value below the arrow.

- The internal-external rotation of the tibia relative to the femur is shown at the bottom of the right view.

• To store the preoperative leg alignment, hold the leg in full extension and press the record but-ton at the bottom of the left view.

- In order to store the initial alignment, the flexion angle can be no greater than 20°. If the angle is greater than 20°, the record button will disappear.

• Once you have recorded the leg alignment, the software will display a warning message if:

- you have selected a Varisation correction during initial setup (see Page 27), and the recorded leg alignment shows the leg is already in varus,

- you have selected a Valgisation correction during initial setup (see also Page 27), and the recorded leg alignment shows the leg is already in valgus.


Figure 85Varisation/Valgisation Warning

• If the selected treatment side is correct, press Accept to proceed to the confirmation of the ini-tial leg alignment values.

• If you would like to change the treatment side, press Cancel and restart the system.


Confirming the Initial Angle

Once the leg alignment has been stored, the software displays the recorded values.

Figure 86Confirm Initial Alignment

• The following information is stored:


- Medial-proximal-tibia angle (MPTA)

- Extension/flexion angle

- Length of hip-ankle line (H/A Length)

- Internal/external rotation of the tibia relative to the femur

- The intersection point of the mechanical axis and the medial-lateral width of the tibial joint-line axis is displayed at the bottom of the image view. The intersection point is displayed as a blue sphere on the tibia.

• Information on how these values are calculated is provided from Page 16.

• The Zoom function can be used to enlarge or reduce the size of the displayed image.

• Press Apply to confirm the initial leg alignment values, and return to the leg alignment screen.

• Cancel exits the procedure, without saving the values.


9.2.2 Planning the Resection Plane

Once the initial leg alignment has been recorded, you can plan the proximal and distal resection planes on the tibia.

• The planning steps are activated by selecting Planning from the menu bar.

• Planning the resection planes is comprised of the following steps:

- Defining the cutting plane end point (on the contralateral cortex)

- Defining the cutting plane start point (optional)

- Adjusting the center of rotation

- Fine-tuning the resection plane

- Adjusting the distal cutting plane to determine post-operative leg alignment

Planning Options If you prefer more manual adjustment options when defining the proximal resection plane, you can choose to define the cutting plane end point, but skip definition of the start point. Depending on how you define the resection plane, various adjustment functions are available to manually position the center of rotation and fine-tune the resection plane.

The table below provides an overview of the available adjustment functions, depending on the meth-od used to define the resection plane.

Table 2: Adjustment Possibilities

• Medial-lateral • Anterior-posterior rotation

• Medial-lateral


• Proximal-distal



• If you choose to skip definition of the cutting plane start point, the system will not have as much information about the resection plane on the actual bone. The additional adjustment steps pro-vide the system with information in order to more accurately display movement of the leg on the navigation screen. Make sure to position the center of rotation and resection plane as accu-rately as possible to match the anticipated location on the actual bone.

If you decided to skip definition of the resection plane start point, the system will not have as much information about the actual position of the center of rotation or the re-section plane on the bone. Therefore, you should make sure to position the center of rotation as accurately as possible to match the estimated position on the actual bone when performing manual adjustments.

NOTE:

• If you inadvertently press the Planning button in the menu bar after planning has been com-pleted, simply press Cancel to return to the main screen. As long as you do not define another cutting plane end point, the previous planning information will be saved.

• If you define the cutting plane end point again (see Page 99), and then press Cancel in this step, all previous planning information will be lost. In this case, all planning steps will need to be repeated.

Definition of Resection Plane

Adjustment Options: Center of Rotation

Adjustment Options: Finetune Resection Plane

Define end point and start point

Define end point only


Defining the Proximal Resection Plane

You are first required to define a point on the surface of the tibia, on the side where the cutting plane will end. The system will use the point you acquire here as the reference to determine the initial cen-ter of rotation on the tibia.

Figure 87Define Tibial Cutting Plane End Point

• Using the Brainlab Pointer, Sharp Tip, you must define a single point at the desired resection level on the medial or lateral tibia.

- If there is a medial defect, the end point of the cutting plane is defined on the medial side of the tibia.

- If there is a lateral defect, the end point of the cutting plane is defined on the lateral side of the tibia.

• Using the sharp tip of the pointer, penetrate the skin at the required location, and pivot the pointer on the bone.




You are now prompted to acquire a second point on the on the surface of the tibia, on the side where your surgical approach will begin.

Figure 88Define Tibial Cutting Plane Start Point

• Using the Brainlab Pointer, Sharp Tip, define a single point at the desired resection level, on the medial or lateral tibia.

- If there is a medial defect, the start point of the cutting plane is defined on the lateral side of the tibia.

- If there is a lateral defect, the start point of the cutting plane is defined on the medial side of the tibia.

• Using the sharp tip of the pointer, penetrate the skin at the required location (if the initial incision has not already been made), and pivot the pointer on the bone.



• You can also skip this step by pressing Skip. Additional adjustment steps will then be available to so that you can manually adjust the center or rotation point (see Page 102) and fine-tune the tibial cutting plane (see Page 103).



Adjusting the Center of Rotation

The cutting plane end point is the reference for the initial position of the center of rotation (the inter-section point of the proximal and distal cutting planes and the point at which the distal plane can be rotated relative to the proximal plane). The software automatically places the center of rotation 5mm toward the center of the knee, from the point you defined as the cutting plane end point (see Page 99).

• In this step, you can adjust the center of rotation to the desired point on the tibial joint-line axis where the proximal resection plane should end. This allows you to determine the depth of the cut, and at the same time, define how much bone will remain unresected.

Figure 89Adjust Center of Rotation

• The tibia is shown in coronal and sagittal views on the screen. The software displays the follow-ing information:

- In the left view, the end point and start point of the cutting plane are indicated by small red spheres.

- The center of rotation is indicated by a large red sphere.

- The software displays the distance between the center of rotation and the start point of the resection plane. This value indicates the depth of the planned cut.

• Using the medial-lateral function buttons at the bottom of the screen, you can adjust the center of rotation on the resection plane to the desired point on the bone where the resection plane should end. The amount of adjustment in millimeters is shown above the arrow buttons.

- The software will recalculate and display the length of the cut, based on the adjusted position of the center of rotation.

- The Default button sets the point back to the default position defined by the software.

• Press Apply to confirm the center of rotation.



The center of rotation point should be defined as accurately as possible. If there is a deviation of a few millimeters between the actual and planned point, the movement of the displayed bone model will not be as accurate.



The system does not have as much information about the resection plane on the bone if you decided to skip definition of the cutting plane start point (see Page 100). Additional adjustment functions are then automatically displayed in the Adjust Center of Rotation dialog.

These adjustments allow the system to more accurately display movement of the leg on the naviga-tion screen. Make sure to match the center of rotation as accurately as possible to the position on the bone where you anticipate actual center of rotation will be.

In this case, the following adjustment functions are available:


• Using the Prox/Dist buttons, you can adjust the proximal-distal position of the center of rotation to the level of the estimated resection. The amount of adjustment in millimeters is displayed above the buttons.

• Using the Ant/Post buttons, you can adjust the anterior-posterior position of the center of rota-tion.

• The Default buttons will set the point back to the originally defined position.

When adjusting the center of rotation, make sure to position the point inside the bone.

If you decided to skip definition of the resection plane start point, the system will not have as much information about the actual position of the center of rotation or the re-section plane on the bone. Therefore, you should make sure to position the center of rotation as accurately as possible to match the estimated position on the actual bone.


Finetuning the Tibia Cutting Plane

Once the center of rotation has been defined, the planned resection plane for the proximal cut is dis-played as a yellow plane on the tibia. The fine-tuning step allows you to adjust the anterior/posterior position of the cutting plane.

Figure 91Finetune Tibia Cutting Plane

• The software has positioned the resection plane according to the defined center of rotation and start point of the sawing plane.

- If you registered the patient using arthroscopy, the software places the planned resection plane parallel to the tibial plateau, based on the points you acquired on the plateaus during registration (see Page 61).

- If you registered the patient without arthroscopy, the software places the planned resection plane perpendicular to the mechanical axis.

• Using the anterior-posterior buttons at the bottom of the dialog, you can adjust anterior-poste-rior rotation of the cutting plane. The adjusted angle of rotation is then displayed above the but-tons.

- The Default button will set the rotation back to the original position (parallel to the tibial pla-teau, or perpendicular to the mechanical axis).

• Press Apply to accept the planned resection plane, and proceed to the next step.


• Cancel exits the planning procedure without saving your changes.

Additional Adjustment Function:

The system does not have as much information about the resection plane on the bone if you decided to skip definition of the cutting plane start point (see Page 100). An additional adjustment function is then automatically displayed in the Finetune Tibia Cutting Plane dialog.


• In this case, the varus/valgus adjustment function is shown:


• Using the arrow buttons, you can rotate the varus/valgus position of the cutting plane around the defined center of rotation. The adjusted angle of rotation is then displayed above the but-tons.

• The Default button will set the rotation back to 0°.

If you decided to skip definition of the resection plane start point, the system will not have as much information about the actual position of the center of rotation or the re-section plane on the bone. Therefore, you should make sure position the resection plane as accurately as possible to match the estimated position on the actual bone.

Leg Alignment The position of the proximal resection plane has been determined based on the planning steps you already performed (see Page 98 to Page 103). In this step, you can rotate the angle of the distal re-section plane relative to the proximal resection plane. The angulation of the resected wedge can be planned and the correction defined in order to achieve the desired leg alignment.

Figure 93Leg Alignment


• The image view on the left displays the tibia according to the recorded leg alignment (see Page 95) and the planned proximal resection plane. The planned distal and proximal cuts are indicated by the yellow planes on the tibia.

- The proximal cutting plane is already positioned according to the position defined in the fine-tuning step (see Page 103).

- The distal plane is placed on the tibia so that it intersects the proximal plane at the center of rotation point you defined (see from Page 101).

- The current wedge angle is displayed top right of the view.

• In the right image view, the software displays the virtually corrected leg based on the current plan. The values indicate what the postoperative varus/valgus angle, MPTA and hip-ankle line will be according to the planned wedge angle.

• The software uses the initial leg alignment values you stored (see Page 97), and the planned resection plane to automatically plan the wedge angle to achieve the following values:

- With a medial defect, the software aligns the leg so that the mechanical axis intersects the tib-ial plateau at 62% of the total medial-lateral tibial diameter (measured from the lateral side).

- With a lateral defect, the software aligns the leg so that the mechanical axis intersects the tib-ial plateau at 38% of the total medial-lateral tibial diameter (measured from the lateral side).

- The planned wedge angle is displayed in the left view.

- The intersection value displayed in the right view and the intersection point is indicated by a blue sphere on the tibia.

• Using the arrow buttons on each side of the tibia, you can rotate the distal resection plane, rela-tive to the proximal resection plane.

- Each time you press the buttons, the wedge angle is adjusted by 1°. The adjusted value is displayed in the left view.

• You can also adjust the varus/valgus angle of the leg using the Var/Val° function buttons. Each time you press this button, the varus/valgus position is adjusted by 1°. The adjusted angle is then displayed above the buttons.

- The Reset button will set the varus/valgus angle back to the originally planned position.

• Using the ant/post° buttons, you can adjust anterior/posterior slope of the distal resection plane. The adjusted slope is then displayed above the buttons and in the left image view.

- The Default button will set the rotation angle back to the originally planned position.

• Press Apply to accept the planned resection planes. This will update the plan, and all subse-quent steps will be based on these values.

• Cancel exits the procedure without saving the adjustments.


9.2.3 Navigation of the Proximal Tibia Resection Plane

Once the resection planes on the tibia have been planned, you can first navigate the proximal re-section plane using either a cutting block adapter or a drill guide.

• You are prompted to select the required navigation method when completing your initial settings (see from Page 27). This setting can also be adjusted at any time from the Osteotomy Options button in the Toolbox.

• Navigation of the resection plane is activated by selecting Prox. Cut Navigation from the menu bar.

Figure 94Cut Navigation Button




• The arrows indicate the direction in which you should move the cutting block to achieve the planned position. The values under the arrows will be zero when the actual plane is aligned with the planned plane.

• The proximal/distal position and varus/valgus angle of the cutting block relative to the planned proximal resection plane is shown in the left image view. In the right view, the software also shows the tibial slope relative to the planned proximal resection.

• If you defined a cutting plane start point (see Page 99), the depth of the planned cut, (the dis-tance between the start point and the center of rotation) is displayed in the right view.


Depending on surgeon preference, proximal tibial resection can either be performed now, or you can proceed directly to navigation of the distal tibial resection plane (see Page 109).





• The arrows indicate the direction in which you should move the drill guide to achieve the planned position. The values under the arrows will be zero when the actual plane is aligned with the planned plane.

- The proximal/distal position and varus/valgus angle of the navigated tool relative to the planned proximal resection plane is shown in the left image view. In the lower right view, the software also shows the tibial slope relative to the planned proximal resection.

- In the upper right view, an axial view of the tibia is displayed. This view shows the anterior-posterior position of the K-wire on the tibia.

- If you defined a cutting plane start point (see Page 99), the depth of the planned cut, (the dis-tance between the start point and the center of rotation) is displayed in the right view.

• Match the current position (blue plane) as accurately as possible to the planned position (yellow plane) and drill the first K-wire according to standard surgical procedure.

• Once the first K-wire has been drilled, press the record button. This allows you to record the position of the first K-wire according to the position of the drill guide.






• The software now displays the navigation screen with the drilled K-wire indicated by a blue line on the tibia.

Figure 98Navigation Screen: Navigate Second K-Wire

• Using the drill guide, you can now navigate the second K-wire to the correct position. The upper right view allows you to align the second K-wire parallel to the first K-wire without intersecting the two wires.

• Once the second K-wire is drilled, the proximal tibial resection can either be performed now (depending on surgeon preference), or you can proceed directly to navigation of the distal tibial resection plane (see Page 109).


9.2.4 Navigation of the Distal Tibia Resection Plane

Once the proximal resection plane has been navigated, you can navigate the distal resection plane on the tibia.

• Navigation of the distal plane is activated by selecting Dist.Cut Navigation from the menu bar.

Figure 99Cutting Block Navigation Button




• The software displays the same information as described for navigation of the proximal resec-tion plane (see Page 106). In this case, however, the software indicates the position of the cut-ting block relative to the distal resection plane.


Resection of the tibia plane can now be performed according to standard surgical procedure.





• The software displays the same information as described for navigation of the proximal resec-tion plane (see Page 107). In this case, however, the software indicates the position of the drill guide relative to the distal resection plane.

• Match the current position (blue plane) as accurately as possible to the planned position (yellow plane) and drill the first K-wire for the distal cutting plane according to standard surgical proce-dure.

• Once the first K-wire has been drilled, press the record button. This allows you to record the position of the first K-wire on the distal plane according to the position of the drill guide.






• The software now displays the navigation screen with the first drilled K-wire for the distal resec-tion plane indicated by a blue line on the tibia.

Figure 103Navigation Screen: First K-Wire drilled

• Using the drill guide, you can now navigate the second K-wire to the correct position. The upper right view allows you to align the second K-wire parallel to the first K-wire without intersecting the wires.

Once the second K-wire is drilled, tibia resection can now be performed according to standard sur-gical procedure.


9.2.5 Closing Wedge Alignment

Once the tibia has been resected, you can close the wedge to achieve the planned leg alignment.

• This function is activated by selecting Cut Alignment from the menu bar.

Figure 104Cut Alignment Button

The Closing Wedge Alignment screen is displayed.

Figure 105Wedge Alignment


• In the left view, the software displays the following information based on the current leg align-ment:

- the varus/valgus angle

- the intersection point of the mechanical axis and the tibial joint-line axis

- the actual length of the hip-ankle line. The difference in millimeters between the current leg length and preoperative leg length is displayed below the total value.

- the medial-proximal tibial angle (MPTA)

• The upper right view displays the internal/external rotation of the tibia relative to the femur.

- The yellow dotted line indicates the A/P direction of the femur.

- The red dotted line indicates the A/P direction of the tibia.

• The arrow indicates the direction in which to adjust the leg to match the planned internal-exter-nal rotation. The value under the arrow will be 0° when the planned rotation has been achieved.

• The lower right view displays the current flexion/extension position of the proximal tibia relative to the distal tibia. The arrow indicates the direction in which to adjust the wedge to match the actual tibial slope to the to the preoperatively defined slope (based on the registered points). The value under the arrow will be 0° when the current slope matches preoperative angle.

• To achieve the planned post-operative leg alignment situation, match the actual position of the mechanical axis (indicated by the blue sphere) to the planned position of the mechanical axis (indicated by the yellow sphere).

• Once the final leg alignment has been determined, you can close and fix the wedge according to standard surgical procedure.


9.2.6 Motion Analysis

Motion Analysis is an optional function that allows you to check the final leg alignment once the resected tibia has been aligned and the bone secured.



Motion Analysis is described in detail from Page 115.


10 ADDITIONAL NAVIGATION FUNCTIONS

10.1 Motion Analysis

Motion Analysis is an optional function that allows you to check the collateral ligament situation of the leg. Motion analysis can be performed before tibia resection and again after the resected tibia has been aligned and the bone secured. In this way you can compare the movement of the leg be-fore and after the performed osteotomy

NOTE: If you are performing the opening wedge osteotomy, make sure the Reference Array, Y-Geometry, X-Press is to the femur (see Page 91) before performing motion analysis.




The Motion Analysis screen is displayed.

Figure 108Motion Analysis Screen

• The tibia and femur are shown indicating the current leg alignment. As you move the leg from extension to flexion and in varus/valgus, the corresponding angular values are displayed.

• The values of the medial and lateral opening of the knee joint are also displayed. These values show the angular difference between the tibia and femur.

• The current values are shown below the arrows. The minimum and maximum values are shown above the arrows, and will be reset after 20 seconds without joint movement.


10.2 Navigation Accuracy

The VectorVision osteotomy software offers integrated accuracy checks which allow you to verify navigation accuracy during surgery.


10.2.1 Accuracy Checkpoints

The checkpoints you defined following registration (see Page 63), are visible on the femur and tibia throughout the procedure. You can monitor accuracy using these points in any navigation screen.

You will be prompted to check navigation accuracy at 30 minute intervals in the Check Femur and Check Distal Tibia dialogs. If you selected the opening wedge procedure, and attach the Reference Array Y-Geometry, X-Press to the proximal tibia (see Page 84), you will be prompted to check ac-curacy in the Check Proximal Tibia dialog.

You can also activate system accuracy at any point during the procedure by selecting the Accuracy Check button from the Tools dialog in the Toolbox (see Page 38).

• You are first prompted to check the femur.

Figure 109Verify Femur

• The defined checkpoints are shown on the 3D bone model as large green spheres.

• Move the pointer to the accuracy checkpoint on the femur, and pivot the pointer.

- If the distance between the tip of the pointer and the checkpoint is less than 2.9mm, the soft-ware automatically proceeds to the next step.

- If accuracy is less than 2.9mm, the reference arrays may have moved. As navigation accu-racy can no longer be guaranteed, the femur should be reregistered (see Page 38).

• If you press Skip, you will be branched to the Check Distal Tibia dialog.

• When femur accuracy has been verified, you are also prompted to check the distal tibia (see Page 119).

• If you selected the opening wedge procedure, you will be prompted to check navigation accu-racy in the Check Proximal Tibia dialog (while the Reference Array Y-Geometry, X-Press is attached to the tibia).


Figure 110Verify Proximal Tibia

• You can verify proximal tibia accuracy using the same technique described for the femur.

• If you press Skip, you will be branched to the Check Distal Tibia dialog.

• Once the femur or proximal tibia has been verified, you are automatically prompted to check the distal tibia.

Figure 111Verify Distal Tibia.

• You can verify tibia accuracy using the same technique described for the femur.

• Press Skip to return to navigation without verifying the tibia checkpoint, or press Previous to return to the Check Femur dialog.


10.2.2 Alignment Check

The software also has an integrated alignment check which verifies that the femoral and tibial axes are correctly aligned. A warning message is automatically displayed indicating a reference array may be incorrectly positioned or that the leg may be out of alignment, if the following occurs:

• the leg is more than 20° in varus or valgus.

• the end point of the femoral mechanical axis has shifted more than 50mm away from the start point of the tibial mechanical axis.

Figure 112Alignment Check

• Press Check Accuracy to verify the accuracy checkpoints you defined (see Page 118).

• If the reference arrays are positioned correctly based on the accuracy check, and the leg is cor-rectly aligned, press Accept to continue the procedure.

Additional functions which allow you to check accuracy during navigation and select the required navigation method are available in the Tools tab in the Toolbox (see Page 38).


10.3 Digitize Points

The Digitized Points function allow the surgeon to mark points of interest and are also useful for verifying system accuracy. They can be set and removed separately for the femur and tibia.

• To set digitized points, simply select either Add Digitized Points Femur or Add Digitized Points Tibia available in the Tools tab in the Toolbox (see Page 38).

The corresponding Digitize Points dialog is displayed:

Figure 113Digitized Points (Left: Femur, Right: Tibia)

• Hold the pointer to the desired area on the femur or tibia to be marked.

• Rotate the tip of the pointer slightly until an acoustic beep is heard. This confirms that the digi-tized point has been acquired.

• The digitized point will be displayed in orange.

• As many digitized points as needed can be acquired.

• If the tip of the pointer is moved close to one of the digitized points, the system will show the distance from the tip of the pointer to the digitized point. If the digitized point is set on the bone, it is possible to verify certain distances, e.g. if the reference array has moved during surgery.

• The most recently acquired digitized point can be removed using the Undo button.

• To exit the digitized points function without setting any points, press Cancel.

• To confirm the digitized points you have set and return to the main screen, press Apply. The digitized points are now shown on the bone model in the main screen.

• To remove all digitized points, select either Delete Digitized Points Femur or Delete Digitized Points Tibia from the Tools tab in the Toolbox.

• This will irreversibly remove all digitized points.

So that all landmarks can be successfully located, all osteophytes must be removed before digitized points are set.


11 SYSTEM SHUTDOWN11.1 Closing the Software and Shutting Down the System

Once surgery has been completed, the system can be shut down.

Always close the software before shutting down the system. Never use the power switch to exit the software as data may be lost!

•The Close Program dialog will be displayed.

•To close the software, press Close.

Figure 114Close Program

• Here you have the option of closing the program, and of restarting the program if required.

• Cancel will branch you back to the previous dialog.

• The software saves your changes by pressing Close Program.

• Once the software has been closed, remove the selected storage medium (e.g. Zip disk or external USB drive) from the appropriate drive.

• Shut down the PC.

• Before switching off the PC and unplugging the power supply, wait until Windows prompts you to do so.

• If a storage medium has not been inserted, the software automatically saves the patient infor-mation to the hard disk.


Failure to follow the correct system shutdown procedure prior to disconnecting the power supply may result in an irreversible loss of data.

When turning the system off, you must wait at least 60 seconds before turning it on again. Otherwise, high input current may trip the circuit breaker.


11.2 Restoring Patient Data

If the system is inadvertently shut down, e.g in the event of a power failure, the following dialog is displayed when you restart the software:

Figure 115Restore Patient Dialog

• To restore the stored session, press Yes.

• To delete the stored session, press No.

• Cancel will open the Close Program dialog.


12 INSTRUMENTATION12.1 Overview

Figure 116Instrumentation for the VectorVision osteotomy Application

The instruments available for the VectorVision osteotomy application are pictured in Figure 116.

From left to right:

(1)

• VV MIRA (Diam. 5mm, Y design)

• VV MIRA (Diam. 5mm, T design)

• Reference Array T-Geometry, X-Press assembled with Bone Fixator “2-Pin”, X-Press

• Reference Array Y-Geometry, X-press assembled with Bone Fixator “1-Pin”, X-Press

(2)

• Pointer Angled

• Brainlab Pointer, Sharp Tip

• Reflective Marker Spheres


(3)

• Drill Guide

• Femoral and Tibial Cutting Block Adapter

• Femoral and Tibial Cutting Block Adapter “Universal”

Refer to the VV Cleaning, Disinfection & Sterilization Guide for all information regarding cleaning, disinfection, and sterilization procedures.

All instrumentation for the VectorVision osteotomy application must be sterilized us-ing a valid sterilization procedure prior to the operation. For cleaning, disinfection and sterilization instructions, please refer to the VV Cleaning, Disinfection & Sterilization Guide.

All instrumentation for the VectorVision osteotomy application must be sterilized after coming in contact with an unsterile environment. For cleaning, disinfection and ster-ilization instructions, please refer to the VV Cleaning, Disinfection & Sterilization Guide.

If the VV Steribox Knee is dropped, the box and all instruments contained within must immediately be sent back to Brainlab for repair.

The instruments for the VectorVision osteotomy application are not MRI compatible.


12.1.1 Using Fixation Pins

The placement of a fixation pin is a standard minimally-invasive and low-risk surgical procedure which is required in order to provide a stable basis for attaching certain reference arrays and per-forming navigation.

However, because an incision is required, please read the following cautions and warnings before continuing:

Because placement of a fixation pin requires an incision one or more of the following complications may occur: infection, local pain, bleeding, lesion of blood vessels or nerves, or the appearance of thrombosis. A bone fracture may also occur.

The fixation pins may be attached using an automatic drill, but the lowest drilling speed should be selected in order to maintain maximum control over the drilling depth.

Only the Schanz screw or K-wire with the specified diameter should be used as the fixation pin. Using a fixation pin with the incorrect diameter could result in unstable attachment. The specified Schanz screw or K-wire must be threaded and the length of the thread should be sufficient to allow bicortical fixation.

To ensure stable attachment, the fixation pin should be positioned bicortically where possible.


12.2 Brainlab Pointer, Sharp Tip

The Brainlab Pointer, Sharp Tip is used for defining the resection plane on the tibia.

Figure 117Brainlab Pointer, Sharp Tip

During registration and navigation, it is important that only the indicated pointer is used. The Brainlab Pointer, Sharp Tip is used for determining the cutting plane start point and end point. The Pointer Angled is used for performing all registration steps.

If the Brainlab Pointer, Sharp Tip is dropped, it must be immediately sent to Brainlab for repair.

Always store the pointer in the appropriate steri case and ensure that the tip matches the counter tip inside the steri case.

Check the accuracy of the pointer tool before use. The case tip must be contained in the steri case.


12.3 Pointer Angled

The Pointer Angled is specially designed for orthopedic applications.

Figure 118The Pointer Angled

As can be seen in the image above, the Pointer Angled has a curved tip. This allows better access in gaps and hard-to-reach areas. It also enables better acquisition of the condyles.

A ball is also found on the tip of the Pointer Angled. This allows smoother movement along the bone and prevents the tip from catching e.g. on bone or cell tissue.

During registration and navigation, it is important that only the indicated pointer is used. The Brainlab Pointer, Sharp Tip is used for determining the cutting plane start point and end point. The Pointer Angled is used for performing all registration steps.

The Pointer Angled should be handled with extreme care, especially during steriliza-tion procedures.

If the Pointer Angled is dropped, it must be immediately sent to Brainlab for repair.

Always store the pointer in the appropriate case of the sterilization tray. and ensure that the tip matches the counter tip inside the case.

Check the accuracy of the pointer tool before use. The tip must match the counter tip inside the case.


12.4 Minimally Invasive Reference Array (Diam. 5mm, Y-Design)

12.4.1 Overview

Figure 119VV MIRA (Y-Design)

The VV MIRA (Y-Design) consists of the following components:

• A reference marker array (1) with a flexible joint

• A screw connector (2) with 4 “teeth” for gripping

• A cap nut (3) for pushing the spikes of the screw connector down into the bone

• A fix knob (4) for securing the screw connector to the fixation pin


12.4.2 Attaching the MIRA (Y-Design)

The MIRA (Y-Design) may only be attached to the femur, never to the tibia.

The MIRA (Y-Design) is attached to the medial or lateral side of the bone, depending on the surgical approach. Please observe the relevant cautions and warnings when attaching the MIRA (Y-Design).

Figure 120Placement of Reference Array on the Femur

• To attach the MIRA (Y-Design), first insert a fixation pin by stitch incision. Carefully secure the fixation pin. This provides a stable basis for the screw connector.

• A Schanz screw with a diameter of 5mm should be used as the fixation pin.

• Once the fixation pin (1) has been secured, slide the screw connector (2) over the inserted fixa-tion pin and slide it down onto the surface of the bone.

Figure 121Placing the Screw Connector Over the Fixation Pin

• Make sure that no soft tissue is left between the jaws of the array and the surface of the bone.

• To secure the screw connector to the fixation pin, tighten the fix knob (1) using the wrench pro-vided (2).


Figure 122Tightening the Fix Knob

• To push the spikes of the screw connector down into the bone, tighten the cap nut (1) using the wrench (2) provided. This prevents the MIRA (Y-Design) from shifting.

Figure 123Tightening the Cap Nut

Handle the spikes with care. If they break while in the bone, this could cause serious injury to the patient.

When placing the Schanz screw for the reference array, you must take into account the placement of the implant components (e.g. plates). If the placement of the refer-ence arrays interferes with the implant components, the reference arrays must be re-moved, and you will not be able to continue with navigation.

• Position the reference array so that it is visible to the cameras at all times and does not interfere with the tracking of other instruments during the procedure.

• The array can be flexibly adjusted due to it’s double-jointed structure.

The screw connector must be attached to the fixation pin as described. Doing other-wise will result in unstable fixation.

Do not open any of the angular adjustment screws of the reference marker array once patient registration has been completed.


Prior to surgery, make sure that the screw connector is not missing any attachment spikes.

If the MIRA (Y-Design) has been damaged, or dropped on the floor, it should no longer be used. Return the device to Brainlab for accuracy testing.

Using a fixation pin smaller in diameter than the specified 5mm may result in an un-stable attachment.

The reference array may only be attached to bony structures, i.e. the femur, never to tissue, blood vessels, or parts of the nervous system. This will cause system innacu-racies as well as injury to the patient.

All screws of the MIRA (Y-Design) must be tightly secured before patient registration. Any movement of the reference array during patient registration will result in incorrect registration.

References to the MIRA (Y-Design) fixation pin signify Schanz screws with a diameter of 5mm. The selected Schanz screw must be threaded. The thread should be long enough to enable bicortical fixation.


12.5 Minimally Invasive Reference Array (Diam. 5mm, T-Design)

12.5.1 Overview

The MIRA (T-Design) is attached and handled in the same manner as the MIRA (Y-Design). How-ever, the MIRA (T-Design) is attached to the tibia for tibia referencing. Please observe the relevant cautions and warnings when attaching the MIRA (T-Design).

Figure 124MIRA (T-Design)

The MIRA (T-Design) may only be attached to the tibia.

The MIRA (T-Design) is attached in the same way as the MIRA (Y-Design). See Page 133 for de-tailed information and relevant cautions and warnings.


12.6 MI Reference Array Kit Osteotomy, X-Press

12.6.1 Overview

Brainlab’s MI Reference Array Kit Osteotomy is specially adapted for osteotomy surgery, and en-ables dynamic, minimally-invasive patient tracking. Fast and flexible reference array adjustment en-sures optimal positioning within the camera field of view. A unique quick fastener mechanism allows reproducible removal and reattachment of the Reference Array, X-Press to the bone fixator.

The MI Reference Array Kit Osteotomy also has a specially-adapted wireless and autoclavable de-sign that facilitates fast, efficient sterilization.

The components pictured below are available for the MI Reference Array Kit Osteotomy:

Figure 125Components of MI Reference Array Kit Osteotomy

• (1) Bone Fixator “2-Pin”, X-Press (2 are supplied in the kit)

• (2) Reference Array T-Geometry, X-Press

• (3) Reference Array Y-Geometry, X-Press

• (4) Bone Fixator “1-Pin”, X-Press (Size M)

The Reference Array T-Geometry and Y-Geometry, X-Press can be used in combination with the Bone Fixator “1-Pin”, X-Press or Bone Fixator “2-Pin”, X-Press.


Figure 126Assembled Reference Arrays, X-PressLeft: Reference Array Y-Geometry, X-Press attached to the Bone Fixator “1-Pin”, X-Press

Right: Reference Array T-Geometry, X-Press attached to the Bone Fixator “2-Pin”, X-Press

The Bone Fixator “1-Pin” and “2-Pin”, X-Press must be used with the corresponding Reference Array, X-Press.

Only attach the Bone Fixator “1-Pin” and “2-Pin”, X-Press to bone structures, never to tissue or parts of the nervous system.

The fixation pins may be attached using an automatic drill, but the lowest drilling speed should be selected in order to maintain maximum control over the drilling depth.

Although screwing standard pins such as Schanz screws into bony structure is a min-imally invasive procedure, one or more of the following complications may occur: infection, local pain, bleeding, lesion of blood vessels or nerves, or the appearance of thrombosis. A bone fracture may also occur.


12.6.2 Bone Fixator “1-Pin”, X-Press

The Bone Fixator “1-Pin”, X-Press provides an interface allowing attachment of the Reference Array, X-Press.

• The Bone Fixator “1-Pin”, X-Press can be mounted to a standard pin.

• The 1-pin solution fits pin diameters of 5 - 6mm.

• The Reference Array, X-Press can then be rotated around the pin, so that it can be adapted to the required approach before fixation.

Figure 127Bone Fixator, “1-Pin, X-Press”: Degrees of Freedom

Assembling the Bone Fixator “1-Pin”, X-Press

The Bone Fixator “1-Pin”, X-Press can only be used if all parts are available for assembly prior to use. Each part is engraved with a part number, making identification easier.

Figure 128Part Numbers on the Bone Fixator “1-Pin”, X-Press

Assemble the Bone Fixator “1-Pin”, X-Press as shown below.


Figure 129Bone Fixator “1-Pin”, X-Press Assembly

• Screw the fixation screw (1) into the inlay (2).

• Screw the traction nut (3) onto the inlay (2).

• Screw (1+2+3) into the tube (4).

Attaching the Bone Fixator “1-Pin”, X-Press

Figure 130Attaching the Bone Fixator “1-Pin”, X-Press to the Bone (Left: Tibia, Right: Femur)

• Once you have assembled the Bone Fixator “1-Pin”, X-Press, slide it over the fixation pin.


Figure 131Bone Fixator “1-Pin”, X-Press: Labeled Parts

• The required orientation of the Reference Array, X-Press should be adjusted prior to tightening the bone fixator to the pin.

• The first step is to tighten the fixation screw (1) with the wrench provided. This secures the bone fixator to the fixation pin. To avoid confusion regarding the order of steps to be performed, the fixation screw is labelled 1st.

• The second step is to fasten the traction nut (3) with the wrench provided to establish the nec-essary pin traction. To avoid confusion regarding the order of fixation, the traction nut is labeled 2nd.

• Make sure that the Bone Fixator “1-Pin”, X-Press fixation screw (1) and traction nut (3) are securely tightened before beginning patient registration.

Before tightening the Bone Fixator “1-Pin”, X-Press to the Schanz screw, you should attach the Reference Array, X-Press (see Page 149) and adjust it so that the camera has full view of the reference array at all times during the procedure.

When placing the pins for the Bone Fixator “1-Pin”, X-Press, you must take into ac-count the placement of the implant components (e.g. plates). If the placement of the pin interferes with the implant components, the pin must be removed, and you will not be able to continue with navigation.

If you are making a small incision to be used only for attaching the base of the refer-ence array, place the pin first into the incision. You can then slide the Bone Fixator “1-Pin”, X-Press over the pin down onto the surface of the bone. This prevents the spikes causing unnecessary injury to the surrounding tissue, e.g. muscles.


Because the Bone Fixator “1-Pin”, X-Press can be rotated around the pin axis, the spike tube must be placed directly on the surface of the bone without penetrating soft tissue. This has to be considered when making the incision, prior to pin fixation.

The Bone Fixator “1-Pin”, X-Press must be used with standard pins (e.g. Schanz screws or K wires) with a diameter of between 5mm and 6mm. The pins must be threaded and the length of the thread must be sufficient to allow bicortical fixation.

Unicortical fixation or using pins smaller in diameter than specified, may cause the pin to be inadvertently removed from the bone when the Bone Fixator “1-Pin”, X-Press is tightened.

Make sure that all screw connections of the Bone Fixator “1-Pin”, X-Press are securely tightened before beginning patient registration. Any movement of the Bone Fixator “1-Pin”, X-Press during or after patient registration will result in incorrect navigation.

Never unscrew the standard pin if the Bone Fixator “1-Pin”, X-Press is still attached, as this will cause extreme abrasion of the corticalis. This step should only be consid-ered if the device cannot be removed using standard procedure.


12.6.3 Bone Fixator “2-Pin”, X-Press

The Bone Fixator 2-Pin”, X-Press provides an interface allowing attachment of the Reference Array, X-Press.

• The Bone Fixator 2-Pin”, X-Press can be mounted to standard pins.

• The 2-pin solution fits pin diameters of 3 or 4mm. Different diameter pins can be combined if required.

Figure 132Bone Fixator “2-Pin”, X-Press,

• (1) Interface holes for attachment to fixation pins

• (2) Interface holes for attachment of the Reference Array, X-Press

• The Bone Fixator “2-Pin”, X-Press does not allow rotation around the pins once the pin is attached to the bone. Therefore, the desired orientation of the Bone Fixator “2-Pin”, X-Pressshould be considered before placing the pins.

Figure 133Bone Fixator, “2-Pin”, X-Press: Degrees of Freedom


The Bone Fixator “2-Pin”, X-Press does not support rotation around the pin axis. Therefore, in order to ensure visibility to the camera at all times, the orientation of the Bone Fixator “2-Pin”, X-Press and the Reference Array, X-Press must be considered prior to inserting the pins into the bone.

Attaching the Bone Fixator “2-Pin”, X-Press

Figure 134Pins inserted on Distal Tibia

Figure 135Pins inserted on Proximal Tibia

• Before the Bone Fixator “2-Pin”, X-Press can be attached, two fixation pins must be screwed into the bone almost parallel to each other.

• Before placing the fixation pins, the required orientation of the Bone Fixator “2-Pin”, X-Pressand the Reference Array, X-Press must be considered. The reflective marker spheres must be visible to the cameras at all times.

• To ensure that the two fixation pins are the correct distance apart, use the “2-Pin” Drill Tem-plate, X-Press provided.


Figure 136“2-Pin” Drill Template, X-Press

• Only use the holes of the drill template that are encircled as shown.

Figure 137“2-Pin” Drill Template, X-Press (Left: Fixation Pins, Right: Corresponding Holes)

Do not attach the Bone Fixator “2-Pin”, X-Press to bone areas covered by strong mus-cles. It is also important to avoid piercing muscle tissue when attaching the Bone Fix-ator “2-Pin”, X-Press. Extensive muscle movement, especially during knee flexion and extension, may cause the pin to bend. This can irreparably damage the pin, leading to reduced navigation accuracy.

When placing the pins for the Bone Fixator “2-Pin”, X-Press, you must take into ac-count the placement of the implant components (e.g. plates). If the placement of the pins interferes with the implant components, the pins must be removed, and you will not be able to continue with navigation.

The Bone Fixator “2-Pin”, X-Press must be used with standard pins (e.g. Schanz screws or K wires) with a diameter of between 3mm and 4mm. The pins should be threaded and the length of the thread should be sufficient to allow bicortical fixation.

If pins longer or thinner than specified are used, these pins could bend or warp, lead-ing to inaccurate navigation.


Unicortical fixation or fixation with pins smaller than specified may result in unstable attachment.

The pins should be drilled into the bone using the “2-Pin” Drill Template, X-Press. Drill-ing directly through the holes of the Bone Fixator “2-Pin”, X-Press may cause fixation pins to be inserted either too close or too far from each other. This may cause the pins to stretch, resulting in irreparable damage to the pins during the fixation procedure.

The Bone Fixator “2-Pin”, X-Press should be used primarily to attach pins to bony structures covered with thin tissue, such as the tibia or iliac crest. Only pins provided by Brainlab should be used. If the provided pins are too short, the covering tissue may be too thick to allow a stable fixation of the Bone Fixator “2-Pin”, X-Press.

The Bone Fixator “2-Pin”, X-Press should be attached as closely as possible to the bone or tissue surface to achieve optimal stability.

Figure 138Attaching the Bone Fixator “2-Pin”, X-Press,

• To attach the Bone Fixator “2-Pin”, X-Press to the bone, slide it over the fixation pins (2).

• Secure the Bone Fixator “2-Pin”, X-Press into position by tightening the screw fastener (1).

• The screw connection can be tightened by hand. A special tool is not required.

• Make sure that the Bone Fixator “2-Pin”, X-Press screw fastener (1) is securely tightened before beginning patient registration.


The Bone Fixator “2-Pin”, X-Press should only be attached to regions of the pins with circular cross section, as the use of other cross sections may cause irreparable dam-age to the Bone Fixator “2-Pin”, X-Press.

The adjustable joints can be sufficiently secured by fastening the screw connection by hand. No special tool is required.

The screw fastener must be tightly fastened before patient registration. Any move-ment of the Bone Fixator “2-Pin”, X-Press during and after patient registration will re-sult in incorrect navigation.

Do not use the interface for the Reference Array, X-Press attachment as a drill tem-plate. Otherwise, wear will lead to inaccurate navigation, resulting in severe patient in-jury.

If the Bone Fixator “2-Pin”, X-Press cannot be removed from the pins for any reason, the pins can be cut below the Bone Fixator “2-Pin”, X-Press and unscrewed separately.


12.6.4 Bone Fixators, X-Press: Attachment Options

If you have selected the opening wedge procedure (see Page 27), the Reference Array Y- Geometry, X-Press can be removed from the femur and attached to the proximal tibia, before performing tibia resection. This allows the system to track the distal and proximal tibia segments rel-ative to each other (see Page 84).

In this case, it is useful to mount a third bone fixator to the proximal tibia before beginning the pro-cedure.

Figure 139Top: Reference Array Y-Geometry, X-Press attached to Bone Fixator, “1-Pin”, X-Press (on Femur)Bottom: Reference Array Y-Geometry, X-Press attached to Bone Fixator “2-Pin”, X-Press (on Tibia)

• Following tibia resection and final leg alignment, the Reference Array Y-Geometry, X-Presscan be reattached to the femur in order to track the femur and tibia relative to each other (see Page 91).

If you are switching the Reference Array Y-Geometry, X-Press from the tibia to the fe-mur (and vice versa) during the navigation procedure, it is important to not change the position or angle of the reference array using the flexible joints. Otherwise navigation accuracy will be reduced.


12.6.5 Reference Array, X-Press

The Reference Array, X-Press is attached to the Bone Fixators, X-Press using a quick fastener. This allows the reference array to be detached and reattached if navigation is not required (e.g., when drilling or sawing).This is also useful if you switch the Reference Array Y-Geometry, X-Pressfrom the femur to the tibia (opening wedge procedure only, see Page 148). This can be performed intra-operatively without the loss of registration information.

• The setup of the operating room should be considered before beginning the procedure to ensure the reflective marker spheres are always visible to the camera.

• If you are switching the Reference Array Y-Geometry, X-Press from the femur to the proximal tibia during the procedure (opening wedge only), you should check the visibility of the reference array on both the femur and proximal tibia before beginning registration and navigation. Once the patient is registered, it is no longer possible to adjust the angle of the reference array on the bone fixator.

If you are switching the Reference Array Y-Geometry, X-Press from the tibia to the fe-mur (and vice versa) during the navigation procedure, it is important to not change the position or angle of the reference array using the flexible joints. Otherwise navigation accuracy will be reduced.

• The Reference Array, X-Press is available with a Y-Geometry and T-Geometry.

Figure 140Reference Array, X-Press(Left: Y-Geometry, Right: T-Geometry)

The Reference Array, X-Press is a measurement device, and if it has been damaged or dropped on the floor, it should no longer be used. Return the device to Brainlab for accuracy testing. Failure to do so could result in severe patient injuries.


Assembling the Reference Array, X-Press

• If all required parts are available you can assemble the Reference Array, X-Press as described below.

Figure 141Reference Array, X-Press Assembly

• Insert the star clamp screw (1) into the spring (2)

• Screw (1+2) into the washer (3)

• Insert the shaft of the reference array (4) into the star clamp (5)

• Screw (1+2+3) into (4+5)

• Screw (1+2+3+4+5) into the quick fastener (6)

Attaching the Reference Array, X-Press to the Bone Fixator

Attach the Reference Array T-Geometry or Y-Geometry, X-Press to the designated junction on the quick fastener. Make sure the fixation hooks (1) on the quick fastener (2) are resting on the slots (3) of the bone fixator (4).

Figure 142Attaching Reference Array to the Bone Fixator

• Two joints allow the adjustment of the reference array to different approaches.

Figure 143Flexible Joints


Figure 144Fastening the Screw Connection

Once the required orientation is set, secure the joints by fastening the screw connection.

• The screw connection should only be tightened by hand. A special tool is not required.

• You must now attach reflective marker spheres as described on Page 167.

Make regular checks to ensure that the marker spheres are properly attached to the pins.

The adjustable joints can be sufficiently secured by fastening the screw connection by hand. Do not use an additional tool as this may result in damage to the compo-nents.

If the interface of the Reference Array, X-Press cannot be completely inserted into the interface of the corresponding bone fixator, the device must be sent back to Brainlab for calibration or replacement. The use of damaged equipment could result in severe patient injury.

The screw for securing the adjustable joints must be tightly fastened before patient registration. Any movement of the Reference Array, X-Press during or after patient reg-istration will result in incorrect navigation.

Incorrect handling may result in bent pins and therefore lead to inaccurate navigation. Ensure that the Reference Array, X-Press is always stored safely to prevent damage to the device. Handle the device with care if it is temporarily detached from the Bone Fix-ator during surgery.


12.7 Drill Guide

12.7.1 Overview

The Drill Guide is a special guidance tool used for navigating drills and K-wires.

Figure 145Drill Guide

• The drill guide tube diameter (1) is available to support 3.0mm K-wires. The diameter is always engraved on the outer surface of the tube.

• The tubes are inserted into the precalibrated reference array (2), and then screwed into place.

• The Drill Guide is also equipped with a special adaptable handle (3). This handle can be rotated by the surgeon so that surgery is not obstructed, and the reference array is always clearly visible to the camera.

The Drill Guide is a highly accurate and sensitive medical instrument. To maintain cal-ibration precision, it must be handled with extreme care. If the Drill Guide is dropped or otherwise damaged, its calibration accuracy should be validated again, or it should be returned to Brainlab for testing.


12.7.2 Assembling the Drill Guide

The Drill Guide must be properly sterilized before use. Details are provided in the Cleaning, Disinfection & Sterilization Guide.

Figure 146Using the Drill Guide

• Select the appropriate tube for the intended application. For example, a 3mm tube must be used for standard 3mm K-wires.

The diameter of the drill guide tube must match that of the drill or K-wire to be used in the operation. Accurate navigation cannot otherwise be guaranteed, and severe injury could be caused to the patient.

• Insert the tube into the drill guide without canting, and screw the tube carefully into the drill guide (counter-clockwise) until it is secure.

The tube must be properly tightened, and should not, under any circumstances, be loosened during use. This will result in critical navigational inaccuracies.

Figure 147Drill Guide Tube Insertion

• Adjust the handle to the most suitable angle and secure it using the fixation nut. The teeth of the handle connection must lock correctly into place.


Once the handle has been adjusted to the required position, ensure that the fixation nut for the handle is properly secured.

Figure 148Drill Guide Handle Adjustment

• Reflective marker spheres must now be screwed securely onto the pins of the reference array.

Make sure that the K-wires are not bent.


12.7.3 Drill Guide Verification

• The drill guide is a precalibrated instrument. The accuracy of the drill guide should be verified before you begin navigation. This is done by pointing the drill guide to known landmarks on the bone and checking the deviation of the drill guide trajectory to the landmark.

• The accuracy check points you defined for the distal tibia (see Page 63), the femur (see Page 64) and for the proximal tibia (opening wedge only, see Page 85) are useful for verifying accuracy.

In case of critical inaccuracies of the drill guide or drill guide tube, do not use the de-vice. In this case, the drill guide should be returned immediately to Brainlab for accu-racy testing.


12.7.4 Drill Guide Navigation

• The trajectory of the drill guide will be displayed on the screen. The drill guide reference array must be clearly visible to the camera at all times.

• To ensure accurate navigation of the drill to the intended target, adjust the Drill Guide to the tra-jectory that is shown on the screen.

To ensure accurate navigation of the planned axis, the spikes of the Drill Guide tube should be placed directly on the bone surface.

• Select a drill or K-wire with the same diameter as that of the tube selected. If you wish to navi-gate a drill of a different diameter, the drill guide tube must be exchanged accordingly.

The Drill Guide should only be used in combination with specified drills and K-wires. Brainlab does not assume liability if other drills or K-wires are used.

The cameras must have an unobstructed view of the reflective marker spheres of the Drill Guide. Otherwise, navigation will not be possible and navigation inaccuracies may occur.

Drilling too deep could cause severe injury to the patient. In critical cases, the drill should be calibrated and the navigated drill depth verified.

Be careful not to change the orientation of the drill guide while drilling. This could cause the drill to fracture and break off in the bone.


12.8 Femoral and Tibial Cutting Block Adapter

12.8.1 Overview

The Femoral and Tibial Cutting Block Adapter is used to navigate the cutting block to the planned resection plane. The adapter allows the system to track the cutting blocks during placement.

Figure 149VectorVision Femoral and Tibial Cutting Block Adapter

The Femoral and Tibial Cutting Block Adapter is adapted to various toolsets, and can be used in combination with the corresponding cutting block.

If you are already using Brainlab instrumentation for knee surgery, you can use the Femoral and Tibial Cutting Block Adapter that is designated to your implant toolset (cutting block).

Otherwise, the Femoral and Tibial Cutting Block Adapter “Universal” should be used for VectorVision osteotomy surgery (see Page 161).


12.8.2 Attaching the Femoral and Tibial Cutting Block Adapter

The base plate is inserted into the cutting block, as shown below. The cutting block adapter must be inserted into the same slot as is used for sawing, otherwise navigation will not be correct.

Figure 150Insertion of the Plane into the Cutting Block

• Insert the Femoral and Tibial Cutting Block Adapter completely into the slot of the cutting block until it stops. Otherwise navigation accuracy may be reduced.

The Femoral and Tibial Cutting Block Adapter must be completely inserted into the slot of the cutting block until it stops. Otherwise navigation accuracy may be reduced.

• Make sure that the Femoral and Tibial Cutting Block Adapter is securely attached to the cut-ting block.

• To ensure a stable attachment of the Femoral and Tibial Cutting Block Adapter to the cutting block, do not insert the Femoral and Tibial Cutting Block Adapter into a sawblade guide that contains openings on its surface.

• You must attach reflective marker spheres as described on Page 167.

• Make sure that the cameras have an unobstructed view of the reference array of the cutting block adapter.

• Once the Femoral and Tibial Cutting Block Adapter has been attached, the cutting block can be matched to the planned location.

Remember to remove the cutting block adapter from the cutting block before sawing.

After extended use, the insertion slot of the cutting block may be enlarged due wear and tear. This may cause a loose fit of the Femoral and Tibia Cutting Block Adapter.

For this reason, the Femoral and Tibia Cutting Block Adapter is equipped with an insertion plate in two thicknesses. If the thinner side no longer fits securely into the cutting block slot usually used, the other side should be used instead.

However, if the adapter no longer fits securely, the cutting block itself should also be checked before proceeding, as it may no longer be accurate.

To ensure a stable attachment of the Femoral and Tibial Cutting Block Adapter to the cutting block, do not insert the Femoral and Tibial Cutting Block Adapter into a saw-blade guide that contains openings on its surface.


The reference array must be mounted to the correct base plate, e.g. after separate cleaning or sterilization.

The Femoral and Tibial Cutting Block Adapter must only be used with specified cutting blocks identified by the name of the implant or the slot thickness.

Make sure to use the Femoral and Tibial Cutting Block Adapter with the specified cut-ting block. The Femoral and Tibial Cutting Block Adapter is adapted specially for each manufacturer and it may not fit properly into an incorrect cutting block. This could cause wear, resulting in reduced navigation accuracy if the Femoral and Tibial CuttingBlock Adapter was subsequently used with the specified cutting block.

If the slot of the cutting block is visibly worn, it needs to be replaced. Accuracy strong-ly depends on the quality of the cutting slot.

Only use the Femoral and Tibia Cutting Block Adapter with cutting blocks specified by Brainlab. Otherwise undesired shifting can occur as the result of a loose fit.

The Femur and Tibia Cutting Block Adapter is a measurement device, and if it has been damaged or dropped on the floor, it should no longer be used. Return the device to Brainlab for accuracy testing. Failure to do so could lead to serious injury to the pa-tient.

Pinning the cutting block to the bone may change its position. Hence it is recommend-ed to check the position of the cutting block after it has been fixed to the bone. Use the cutting block adapter or the pointer to check the position.

While fixing the cutting block to the bone, continuously check the actual plane is matched with the planned plane.

Some manufacturers have cutting blocks with several cutting slots. The resection must be performed through the same slot that the cutting block adapter is inserted into during navigation.


Do not use the Femur and Tibia Cutting Block Adapter for manipulation of the position or orientation of the cutting block. This could cause the plate to bend resulting in nav-igation inaccuracies. Do not hold the Femur and Tibia Cutting Block Adapter with the cutting block still attached.

Make sure that the base plate of the Femoral and Tibial Cutting Block Adapter is com-pletely inserted into the cutting slot prior to placing the cutting block on the bone. Dur-ing the pinning of the cutting block to the bone, the Femoral and Tibial Cutting Block Adapter might move out of the slot. Therefore, regularly check and ensure that the Femoral and Tibial Cutting Block Adapter is completely inserted. Not doing so will lead to an unstable attachment and result in inaccurate navigation.


12.9 Femoral and Tibial Cutting Block Adapter “Universal”

12.9.1 Overview

The Femoral and Tibial Cutting Block Adapter “Universal” is used to navigate the cutting block to the planned resection plane. The adapter allows the system to track the cutting blocks during placement.

Figure 151Femoral and Tibial Cutting Block Adapter “Universal”

The Femoral and Tibial Cutting Block Adapter “Universal” is self-adapting to cutting blocks with a slot thickness of 1.0mm - 1.8mm.


12.9.2 Assembling the Femoral and Tibial Cutting Block Adapter “Universal”

Prior to use, the Femoral and Tibial Cutting Block Adapter “Universal” must be assembled as shown below.

• The reference array (1) is attached to the base plate (2) by pulling the handles of the reference array up and fitting the reference array onto the circular opening on the base plate.

• The reference array can be removed from the base plate by pulling the handles up and moving the baseplate away from the reference array.

Figure 152Assembling the Device

• To attach the reference array to the base plate, first, pull the handles (H) of the reference array upwards as shown below.

Figure 153Pull the Handles Upwards

• While continuing to hold the handles, attach the reference array (A) to the base plate (B).


Figure 154Attaching the Reference Array to the Base Plate

• The assembled Femoral and Tibial Cutting Block Adapter “Universal” is pictured below:

Figure 155Assembled Cutting Block Adapter


12.9.3 Attaching the Femoral and Tibial Cutting Block Adapter “Universal”

Attach the Femoral and Tibial Cutting Block Adapter “Universal” to the cutting block by inserting the base plate fully into the slot as shown in Figure 156 and Figure 157.

To prevent damage to the thin base plate, the interface between the adapter array and the base plate is flexible.

Figure 156Femoral and Tibial Cutting Block Adapter “Universal” Insertion

Figure 157Femoral and Tibial Cutting Block Adapter “Universal” Inserted


During positioning and drilling, the unit (Femoral and Tibial Cutting Block Adapter “Universal” and cutting block) must be held on the cutting block as shown below:

Figure 158Positioning

Do not attach the Femoral and Tibial Cutting Block Adapter “Universal” to cutting blocks with a slot thickness larger than the specified 1.8mm as this will result in un-stable attachment and lead to inaccurate navigation.

Make sure that the base plate of the Femoral and Tibial Cutting Block Adapter “Univer-sal” is completely inserted into the cutting slot prior to placing the cutting block on the bone. During the pinning of the cutting block to the bone, the Femoral and Tibial Cutting Block Adapter “Universal” might move out of the slot. Therefore, regularly check and ensure that the Femoral and Tibial Cutting Block Adapter “Universal” is completely inserted. Not doing so will lead to an unstable attachment and result in in-accurate navigation.

If the base plate cannot be fully inserted into the cutting slot, the cutting slot might not be compatible with the base plate or the base plate might be damaged. In the latter case, the device must be sent back to Brainlab for calibration/replacement as the use of damaged equipment could result in severe patient injury!

To ensure stable attachment to the cutting block, the Femoral and Tibial Cutting Block Adapter “Universal” should not be inserted into a cutting block containing openings on its surface.

Make sure that the Femoral and Tibial Cutting Block Adapter “Universal” adapter array does not touch other instruments, reference arrays, the patient’s body or the sur-geon’s hand during positioning and attachment the cutting block to the bone as this will lead to inaccurate navigation of the resection plane.


Some instrument sets might have cutting blocks with slots too narrow to enable a sta-ble attachment of the Femoral and Tibial Cutting Block Adapter “Universal”. Therefore, check prior to the surgery whether the Femoral and Tibial Cutting Block Adapter “Uni-versal” can be completely inserted into the cutting slot of the cutting blocks to be used.


12.10 Disposable Reflective Marker Spheres

12.10.1 Overview

Reflective marker spheres serve as a communication interface between the surgical field and the navigation station.

All instrument adapters and reference arrays to be navigated or tracked must be equipped with re-flective marker spheres.

The cameras detect the spheres and calculate the geometrical position of the corresponding instru-ment.

The set up of the operating room should be planned prior to the operation, keeping in mind reflective marker spheres must always be visible to the camera.

Figure 159Disposable Reflective Marker Spheres

The reflective marker spheres are delivered sterile. They are disposable and must be disposed of after each use.

Do not re-sterilize disposable reflective marker spheres as this may reduce accuracy, posing a risk to the patient.

Verify that the surface of all reflective marker spheres is in good condition prior to use. In order to provide maximum precision, make sure that the reflective surface does not peel.


12.10.2 Use

• To attach a reflective marker sphere put the sphere’s drill hole to the thread of the reference array respectively pointer.

• Tightly screw the reflective marker sphere by hand onto the reference array or pointer tool.

Figure 160Attaching Reflective Marker Spheres

Make sure the reflective marker spheres are properly fixed to the clamp feet.

Ensure that the reflective marker spheres can be screwed onto the pin until there is no gap between the sphere and the base of the pin. Do not use a reflective markers sphere if it is not securely attached in this position.

If it is necessary to apply excessive force in order to screw a marker sphere onto the pin, the marker sphere should be disposed of, and a new marker sphere used.

The reflective marker spheres must not be totally or partly contaminated with blood, tissue or other substances or liquids as this may decrease the marker spheres' reflec-tivity. The decrease in reflectivity may lead to inaccurate tracking. If a reflective marker sphere is soiled, clean and dry it before use, or replace with a new marker sphere.

Only use a soft cloth moistened with sterile water to clean the surface of soiled marker spheres. Ensure that the cleaned marker sphere is absolutely dry before use.

Do not use defective or deformed reflective marker spheres.

If a marker sphere has been cleaned or replaced, the accuracy of the navigation sys-tem must be verified before navigation can continue.

Disposable reflective marker spheres are highly sensitive medical devices. They should be handled with care and not dropped.


Observe the relevant storage guidelines.

If you use reflective marker spheres on oscillating instruments or under harsh condi-tions, you must check the marker spheres on a regular basis to make sure that they are properly secured.

Make sure that the cameras have an unobstructed view of the reflective marker spheres at all times, otherwise navigation will not be possible.

Clinical User Guide Rev 1.2 VectorVision osteotomy Ver 1.0 I

INDEX

INDEXA

Additional Adjustment FunctionsCenter of Rotation ......................................... 79, 102Finetune Tibia Cutting Plane ............................. 82, 103

Additional Documentation ........................................ 10Additional Navigation Functions ................................ 115Adjust Center of Rotation......................................... 79

Closing Wedge.................................................. 101Opening Wedge ................................................. 79

Alignment Check ................................................. 120Alignment Settings ................................................ 65Application Overview.............................................. 13Available Procedures

Closing Wedge.............................................. 15, 93Opening Wedge ............................................ 14, 71

Available Workflows............................................... 68

BBackground Information .......................................... 14Bone Fixator

"1-Pin", X-Press................................................. 139"2-Pin", X-Press................................................. 143

Bone Model ........................................................ 39Brainlab Accessories................................................ 6Brainlab Pointer, Sharp Tip........... 69, 77, 78, 99, 100, 130Brainlab Service Numbers........................................ 34

CCamera Displays .................................................. 31

Conventions ...................................................... 32Camera Field of View ............................................. 31Cautions .............................................................. 3Check Tibia........................................................ 118Closing Wedge........................................... 15, 68, 93Closing Wedge Procedure .................................. 27, 93Compatibility Information ........................................... 6Confirm Initial Angle

Closing Wedge................................................... 97Opening Wedge ................................................. 74

Creating a Screenshot ............................................ 43Cut Alignment


DDefine Accuracy Checkpoint

Distal Tibia........................................................ 63Proximal Tibia .................................................... 85

Define Proximal Resection PlaneClosing Wedge................................................... 99

Define Resection PlaneOpening Wedge ................................................. 77

Define Tibial Cutting Plane End PointClosing Wedge................................................... 99Opening Wedge ................................................. 77

Define Tibial Cutting Plane Start PointClosing Wedge.................................................. 100Opening Wedge ................................................. 78

Define Tuberositas ................................................ 62Defining Accuracy Checkpoints.................................. 63Digitized Points

Add .......................................................... 38, 121Delete ....................................................... 38, 121

DisposableReflective Marker Spheres .................................... 167

Draping ............................................................. 21

FFemoral and Tibial Cutting Block Adapter “Universal” ....... 161

Assembling ...................................................... 162Attachment ...................................................... 164

Femoral EpicondylesRegistration ...................................................... 58

FemurMechanical Axis ................................................. 60

Finetune Tibia Cutting Plane ............................... 81, 103Closing Wedge.................................................. 103Opening Wedge ................................................. 81

Fixation Pins ...................................................... 129

GGauss limit ......................................................... 21General Manual Information ....................................... 9General Platform Information .................................... 11General Workflow ................................................. 19

HHandling the Pointer ............................................. 131Hip Center.......................................................... 54

Accuracy.......................................................... 54Hip Joint

Registration ...................................................... 54Hip-Ankle Line ..................................................... 17

IImplant

Planning .......................................................... 65Implant Settings

DePuy............................................................. 65Indications for Use .................................................. 5Info tab.............................................................. 34Information Functions ............................................. 43

II Clinical User Guide Rev 1.2 VectorVision osteotomy Ver 1.0

INDEX

Initial Angle DefinitionClosing Wedge................................................... 95Opening Wedge ................................................. 73

Initial Settings ...................................................... 25Initial Setup......................................................... 21Instrument Adapters............................................... 67Instruments........................................................ 127Intersection Point .................................................. 17Intraoperative Tracking ........................................... 66

KK-Wires ............................................................ 152

LLandmark Acquisition

Direction .......................................................... 49Multiple............................................................ 49Single ............................................................. 48

Left-Right Conflict ................................................. 51Leg Alignment................................................ 83, 104


MMain Screen........................................................ 29Malleolus

Medial and Lateral............................................... 55Manual Information.................................................. 9Marker Spheres................................................... 167Measurement Precision........................................... 21Mechanical Axis

Femur ........................................................ 16, 60Tibia .......................................................... 16, 61

Mechanical Leg Axis .............................................. 16Medial Proximal Tibial Angle ..................................... 17medial proximal tibial angle ...................................... 56Medial-Lateral Conflict ............................................ 51Menu Bar ........................................................... 30MI Reference Array Kit Knee, X-Press......................... 137

Attaching Reference Arrays ................................... 149MI Reference Array Kit Osteotomy ............................. 137MI Reference Arrays, X-Press

Y and T Geometry ............................................... 69Mikulicz line ........................................................ 54MIRA

Attachment ...................................................... 133Fixation Pins .................................................... 135Placement on Femur ........................................... 133Placement on Tibia ............................................. 136Y and T-Design ............................................. 46, 69

MIRA (5mm, T-Design) .......................................... 136MIRA (5mm, Y-Design) .......................................... 132Monitor Setup ...................................................... 21Motion Analysis .............................................. 92, 114MPTA ............................................................... 56

NNavigating Leg Alignment ........................................ 68Navigation .......................................................... 65

Cutting Block ..................................................... 28Cutting Block Adapter ........................................... 69

Cutting Block Adaptor .......................................... 106Drill Guide ........................................................ 69K-Wires ........................................................... 28Overview.......................................................... 65Preparation ....................................................... 23Tools .............................................................. 69

Navigation Functions.............................................. 40Cut Alignment .................................................... 40Cut Navigation ................................................... 40Distal Cutting Plane ............................................. 40Motion Analysis .................................................. 41Planning .......................................................... 40Prox. Cut Navigation ............................................ 40Set Initial Angle .................................................. 40

Navigation MethodSelect ............................................................. 28

Navigation StepsClosing Wedge................................................... 94Opening Wedge ................................................. 72

Navigation With Cutting Block AdapterClosing Wedge........................................... 106, 109Opening Wedge ................................................. 86

Navigation With K-WiresClosing Wedge........................................... 107, 110Opening Wedge ................................................. 87

Non-Brainlab Devices............................................... 7

OOpening Wedge .............................................. 68, 71opening wedge procedure................................... 27, 71Osteophytes........................................................ 45Osteotomy Options........................................... 27, 69

PPatient Identification .............................................. 25Patient tab.......................................................... 36Pivoting ............................................................. 48Plan Resection Plane


Planning OptionsClosing Wedge................................................... 98Opening Wedge ................................................. 75

Planning Overview ................................................ 65Plateaus

Tibia ............................................................... 61Platform Information .............................................. 11Plausibility Check.................................................. 51

Detect Reference Arrays ....................................... 52Left Right Conflict................................................ 51Medial Lateral Conflict .......................................... 51Reference Array Confusion .................................... 52

Pointer Angled ............................................... 69, 131Power Switch ...................................................... 21Prepare Arthroscopy Equipment................................. 59

RReference Array Y-Geometry, X-Press

On Femur.................................................... 42, 91On Tibia........................................... 42, 47, 84, 148

Reference Arrays.................................................. 66Visibility ........................................................... 47

Reference Arrays, X-Press

Clinical User Guide Rev 1.2 VectorVision osteotomy Ver 1.0 III

INDEX

Y and T Geometry ............................................... 46Reflective Marker Spheres ...................................... 167Registration ........................................................ 45

Calculation and Adaption ....................................... 63Hip Center ........................................................ 54Hip Joint .......................................................... 54Methods .......................................................... 48Preparation ....................................................... 23Tibia ............................................................... 55With Arthroscopy ................................................ 27Without Arthroscopy............................................. 27

Registration Accuracy............................................. 54Registration Steps ................................................. 54

Standard .......................................................... 53Registration Type............................................. 50, 53

Model Creation................................................... 50No Model Creation .............................................. 50Select ............................................................. 27

ReregistrationFemur/Tibia ...................................................... 38

Resection........................................................... 75Restoring Patient Data........................................... 125

SScreenshot ......................................................... 37Set Initial Angle


Settings tab......................................................... 35Software

Overview.......................................................... 29Software Functions

Menu Bar ......................................................... 30Sound Configuration .............................................. 35Spheres............................................................ 167Standard Registration ............................................. 53Startup .............................................................. 21Startup Settings.................................................... 21Status Fields ....................................................... 33

Conventions ...................................................... 33System

Functions ......................................................... 34Setup.............................................................. 21

System FunctionSettings Tab...................................................... 35

System FunctionsDisplay Setup tab ................................................ 36Info tab............................................................ 34Patient Tab ....................................................... 36Saved Screenshots Tab ........................................ 37Settings ........................................................... 35

System SetupPosition ........................................................... 21

System Shutdown ................................................ 123System Version .................................................... 34

TTarget ............................................................... 39Tibia

Contour ........................................................... 59Mechanical Axis ................................................. 59Plateaus .......................................................... 61

Tibia A-P DirectionRegistration ...................................................... 59

Tibia Registration .................................................. 55Tibial AP Alignment ............................................... 43

Tibial Contours..................................................... 59Tibial Joint-Line Axis .............................................. 17Tibial Slope......................................................... 17Toolbox

Accuracy Check ................................................. 38Osteotomy Options.............................................. 38

Toolbox FunctionDigitized Points ................................................. 121

Toolbox Functions................................................. 38Tools .............................................................. 38

Tools ................................................................ 38Tracking Functions ................................................ 42Treatment Side .................................................... 26

Select ............................................................. 27Tuberositas

Tibia ............................................................... 62Turning on the System............................................ 24Type of Procedure

Select ............................................................. 27

VValgisation ......................................................... 27Varisation........................................................... 27Varus/Valgus Angle ............................................... 17VectorVision Cleaning, Disinfection & Sterilization Guide .... 10VectorVision compact............................................. 11VectorVision sky ................................................... 11VectorVision System User Guide................................ 10VectorVision²....................................................... 11Verify Accuracy

Alignment Check ............................................... 120Distal Tibia ...................................................... 119Proximal Tibia................................................... 119

View Management ................................................ 39

WWarnings ............................................................. 3Wedge Alignment ........................................... 89, 112Workflow

General ........................................................... 19

XX-Press Bone Fixator "1-Pin"

Assembly ........................................................ 139Attachment to Bone ............................................ 140

X-Press Bone Fixator "2-Pin"Attachment to Bone ............................................ 144

X-Press Reference Array ........................................ 138Assembly ........................................................ 150

ZZoom................................................................ 39

IV Clinical User Guide Rev 1.2 VectorVision osteotomy Ver 1.0

INDEX

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