Robotics

Neil Badlani MD, MBAThe Orthopedic Sports Clinic

Nobilis Health Corp.Houston, TX

The Orthopedic Sports Clinic

Disclosure

• Consulting/Speaking

– Medtronic

– Amendia

– Nutech

– Mazor *

– MIS Device

Outline

• Background/Applications

• Advantages/Disadvantages

• Robotic technique

• Clinical evidence

• Cases

My Experience

• 3 years

• 100+ cases

• Initial Motivation

– Less radiation

– Optimize comfort with anatomy and screw placement

• Started with larger cases and open cases

• Now I use it for every instrumented case

The Robot fits naturally into MISS

Surgical methods devised to achieve objectives of traditional surgery with minimized damage to peripheral tissues.

Mazor Robotics Renaissance

• Only FDA-approved robotic guidance system for spinal surgery

• Tens of thousands of screws placed • Available about 55 sites in the US, 95 internationally• The next step in the evolution of spine surgery

7www.MazorRobotics.com

CT-based

3D Planning Software

• CT-based 3D planning

• Guided instrumentation

• 1 mm accuracy

RBT UnitWorkstation

System components:

Computer Navigation- Intraop Robot

Renaissance Applications Spine Surgery

Posterior Surgical Approaches:

• Open

• MIS

• Percutaneous

Thoracic, Lumbar, Sacrum:

Spinal Fixation

Pedicle screws

Transfacet, translaminar-facet screws

Sacroiliac screws

SI fusion

Spinal Deformities

Scoliosis PSF, osteotomies

Cement Augmentations

Kyphoplasty and vertebroplasty

Oncological Applications

Biopsies, Tumor resections

Revisions

Advantages• Surgeon

– Less Radiation!! (34s vs 77s per screw)– Increased confidence, improved accuracy– Decreased time per screw– Marketing

• Patient/Clinical– Increased precision, accuracy, safety– Some studies show 10% misplaced screws, 1-2%

nerve injury

• Hospital– Increased volume, marketing

References

1. Kantelhardt et al. Eur Spine J 20102. Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine. 2007;32(3):E111-20.3. Gertzbein SB, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine. 1990;15(1): 11-4.

Radiation Risks

• Ortho Hospital in Italy,

1976-2000

• Ortho – 29%

incidence

• Ortho Surgeons 5x

increased cancer risk

• In Vitro study

• Open bilateral pedscrews T11-S1 on 6 cadavers

• 10-12 X greater than non-spinal MIS procedures

References1. Singer, Occupational radiation exposure to the surgeon, Am Acad Ortho Surg. 2005;13:69-76.2. Mastrangelo G, Fedeli U, Fadda E, Giovanazzi A, Scoizzato L, Saia B. Increased cancer risk

among surgeons in an orthopaedic hospital. Occup Med. 2005;55(6):498-500.

Disadvantages

• Surgeon– Learning Curve- Minimal

• First 30 cases-> more conversion

to manual but equal accuracy

– Setup Time- Minimal

• Patient/Clinical– Difficult to prove true clinical benefit

• Hospital• COST!- Capital cost 750K

• No increase in revenue per case

References

1. Hu, Lieberman CORR 2013

How it works: step 1

1414

Step 1:

Preoperative

Plan

Step 4:

Operate

Step 2:

Mount

Step 3:

3D Sync

A CT using the Mazor protocol is obtained pre-op.

Plan screw placement to fit anatomy.

Pre-op planning• Time spent and the exercise is beneficial for

every case

• Increases understanding of variability in anatomy

• Notice asymptomatic misplaced screws in revisions

• Intra-Operative plan differs

between open, MIS, revisions.

How it works: step 2

16

16

Step 1:

Preoperative

plan

Step 4:

Operate

Step 2:

Mount

Step 3:

3D Sync

Multiple mounting options fit your intraoperative needs.

Mounting

PSIS and spinous process pins placed

Robot bridge attached to pins

Mounting

PSIS and spinous process pins placed

Mounting

Robot bridge attached to pins

HOW IT WORKS – STEP 3

2020

Step 4:

Operate

Step 2:

Mount

Step 3:

3D Sync

-Two fluoroscopy images taken intraop-Synchronized with the CT-based surgical blueprint (independent of anatomy). -Registers each vertebral body independently for unparalleled accuracy.

Step 1:

Preoperative

plan

Registration

AP and Oblique xrays taken with registration markers

Registration

AP and Oblique xrays taken with registration markers

How it works: step 4

2323

Step 4:

Operate

Step 2:

Mount

Step 3:

3D Sync

Step 1:

Preoperative

plan

Operate

Operate

Operate

Clinical Evidence Mazor Robotics

98.3% Accuracy of 3,271 implants in 635 cases in 14 medical centers

with 49% of implants placed percutaneously

(typically 10%-20% of spine surgeries are MIS)

Devito DP, Kaplan L, Dietl R, et al. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine J. 2010;35(24):2109-2115.

28www.MazorRobotics.com

Clinical Evidence Mazor Robotics

Compared to freehand surgery, in 112 cases Mazor Robotics-guided surgery significantly:

• Screw Accuracy

94.5% Mazor vs 91.4% Conventional (p<0.05)

• Reduced X-ray dosage by 56%

• Reduced complication rates and LOS

• OR time equivalent

Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, GieseA, Rohde V. Perioperative course and accuracy of screwpositioning in conventional, open robotic-guided andpercutaneous robotic-guided, pedicle screw placement.Eur Spine J. 2011;20(6):860-868.

Clinical Evidence Mazor Robotics

99.7% Clinical Acceptance of 1,815 implants in 120 scoliotic adolescentsDevito DP, Gaskill T, Erikson M, Fernandez M. Robotic based guidance for pedicle screw instrumentation of the scoliotic spine. Presented at Pediatric Society of North America (POSNA); May 2011; Montreal, Canada.

Clinical Evidence Mazor Robotics

98.9% “successful and accurate” screw placement in 960 screws in 95 patients (deformity and revision surgeries)

Hu, X, Ohnmeiss D. Lieberman,I. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J (2013) 22:661-666.

CasesL4-S1 open posterior with high grade spondylolisthesis

CasesL5-S1 percutaneous posterior after ALIF

CasesMulti-level percutaneous instrumentation after LLIF

Why Robotic Spinal Surgery?

• Less radiation

• Safety is improved

• Better outcomes with MIS

• Allows safer treatment of complex deformity

• No additional cost to the patient

Thank You