paragon™ surgical technique · the paragon™ hip stem can be inserted with equal ease using a...

PARAGON™ SURGICAL TECHNIQUE

1 Table of Contents

2 Indications & Contraindications

3 Surgical Technique at a Glance

4 Pre-operative Planning

6 Preparation of the Femur

7 Broaching

9 Implant Insertion

10 Implant Dimensions

11 Implant Catalog

13 Instrument Catalog

TABLE OF CONTENTS

Note: Please refer to the Product Insert (Instructions for Use) for important information pertaining to the product description and handling, indications for use, warnings and precautions, possible adverse effects, and contraindications.

1 | PA R AG O N S U R G I C A L T EC H N I Q U E

PARAGON SURGICAL TECHNIQUE

Indications for UseThe Paragon™ Hip System is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

1. Degenerative osteoarthritis of the hip.

2. Inflammatory arthritis of the hip.

3. Secondary arthritis of the hip, such as may follow trauma (e.g. fracture of the femoral neck, or fracture and/or dislocation of the hip or acetabulum), or congenital conditions (e.g. developmental dysplasia of the hip).

4. Displaced intracapsular femoral neck fractures where there is a high risk of non-union or avascular necrosis and bone collapse.

5. Avascular Necrosis of the femoral head.

ContraindicationsAbsolute contraindications include:

1. Infection or sepsis or osteomyelitis.

2. Insufficient bone structure or quality which may affect the stability of the implant.

3. Rapid joint destruction or bone absorption.

4. Skeletal immaturity.

5. Muscular, ligamentous, neurological, vascular deficiencies or poor skin coverage, which may compromise the affected extremity.

6. Alcoholism or the other addictions.

7. Sensitivity to the implant materials.

8. High levels of physical activity e.g. competitive sports, heavy physical labour.

9. Obesity that can produce loads on the prosthesis, which can lead to failure of the fixation of the device or the device itself.

Relative contraindications include:

1. Uncooperative patient or a patient with neurological disorders and incapable of following instruction.

2. Metabolic disorders which may impair bone formation or bone quality.

3. Distant foci of infections.

INDICATIONS & CONTRAINDICATIONS

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SURGICAL TECHNIQUE AT-A-GLANCE

Femoral canal prep/ box osteotome.

Femoral canal opening starter reamer.

Broaching.

Trial reduction. Femoral component insertion. Femoral head assembly.



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Suggested Templating MethodWork from accurate radiographs. Ensure that the pelvis is centered over the pubic symphysis for the A/P pelvis radiograph. For the lateral radiograph use a Lauenstein technique (from leg lateral). It is recommended to use a radiographic marker or scale.

Measure the diameter of the intramedullary canal. Using the templates provided, check at the isthmus on both the A/P and lateral radiographs. Select a stem size between the two readings as the target for stem broaching. The templates are provided at 100% and 120% magnification for compatibility with standard radiographs.

Determine the hip’s center of rotation. Size the acetabular component using the appropriate templates. If medialising the acetabular shell the native center of rotation may be slightly different from the center of rotation for the templated interface porous shell. Place a

PREOPERATIVE PLANNING

small mark on the radiograph at the center of rotation of the selected porous shell.

Determine preoperative leg length correction. Using the A/P pelvis radiograph, determine the leg length discrepancy from the contralateral hip or other clinical methods. Select a stem size that fits the intramedullary canal and fills the proximal metaphysis. Position the selected templated size on the A/P pelvis radiograph and select a neck angle and offset that places the “0” neutral femoral head at a position to correct the leg length discrepancy.

Determine neck resection. Note the distance from the shoulder of the selected femoral stem to the lesser trochanter. Templates are printed with graduated markings for reference.

Note: The final component size is to be determined intra-operatively. Templating is for planning purposes only.

Figure 1

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Surgical ExposureThe approach to the hip is the surgeon’s choice; it varies and is influenced to a degree by the pathology present.

The Paragon™ Hip Stem can be inserted with equal ease using a posterior, posterolateral, anterolateral, straight lateral or transtrochanteric approach. The direct anterior approach (DAA) can also be achieved utilizing the Paragon™ DAA instrumentation. Please refer to the seperate DAA Surgical Technique if this is the approach of choice (HL-040).

Femoral Neck ResectionThe resection level may be determined in a number of ways, including the following:

1. Place a finger above the lesser trochanter, approximating 2cm.

2. Use the resection guide provided with the Paragon™ Hip System. If you choose to use the resection guide, please note that one guide is provided for all stem sizes. Superimpose the guide on the proximal femur. The longitudinal axis of the guide should be parallel to the longitudinal axis of the femur. The resection guide can also be positioned by using the scale on the medial edge of the guide to move the templated distance above the lesser trochanter, or by aligning the lateral ruler with the tip of the greater trochanter.

3. Determine the midpoint between the lesser trochanter and the femoral head in relatively normal anatomical situations. The level of the neck osteotomy may be marked with either a saw or methylene blue. Note that the angle of the osteotomy cut is 45 degrees to the long axis of the femur.

Femoral Neck ResectionAfter the femoral neck osteotomy is complete, prepare and implant the acetabular components.

PREOPERATIVE PLANNING

Figure 2



Femoral Canal PreparationExpose the proximal femur so there is unimpeded preparation of the canal and insertion of the stem. Use a femoral elevator and a trochanteric retractor that adequately retracts the gluteus medius and gluteus minimus muscles to assist with the exposure.

It is critical that the gluteus medius tendon is retracted laterally to expose the greater trochanter. This will assist with neutral placement of the broach and help to avoid varus stem placement.

Femoral Canal OpeningOpen the proximal femur to the piriform fossa by using the box chisel (fig. 3).

Employ the starter reamer to further identify the path of the intramedullary canal of the proximal femur working laterally and posteriorly (fig. 4).

Note: When x-ray templating shows a steeply tapering intramedullary canal, distal reaming may be performed prior to broaching to assist with insertion of the broaches and stem.

PREPARATION OF THE FEMUR

Figure 3

Figure 4

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BroachingStart with the smallest broach attaching it to the broach handle. During broaching periodically withdraw the broach to help clear the broach teeth of bone fragments (fig. 5).

Advance the cutting teeth of the selected broach to the depth of the neck resection or to depth established in pre-operative planning

Continue the broaching process increasing the broach size sequentially until the broach size matches the size of the required implant. Once the final broach has been used it should be seated into the final implant position. Assess the stability of the broach to assure that the correct size implant has been selected.

Note: To minimize the risk of varus positioning, clear out bone from the medial aspect of the greater trochanter using the broaches.

BROACHING

Figure 5

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Trial ReductionBury the teeth of the final broach to the resection level and disengage the broach handle.

Note: Due to the progressive neck lengths of the Paragon™, there will be gaps between trial necks and broaches of various sizes. A positive magnetic end-feel confirms the appropriate sitting of the trial neck on the broach.

Select the trial neck based on pre-operative planning and on your previous intra-operative assessments. Slide the appropriate trial neck onto the broach. Place a modular trial head onto the trial neck and reduce the hip (fig. 6).

Assess leg length, range of motion and stability. Adjust as necessary by choosing a different neck/head combination.

Leg length and offset may be fine-tuned by changing the neck and/or heads. Where possible select a 0 or -3.5mm femoral head with an offset stem instead of increasing offset with head length.

Remove the trial neck, reattach the broach handle and remove the broach.

Figure 6

PREPARATION OF THE FEMUR

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Femoral Component InsertionSelect the Paragon™ stem that correlates to the same size as the last used broach. Engage in the femoral canal by hand and finish its introduction with the impactor for the last few centimeters (fig. 7).

Note: The stem is 0.30mm thicker than the corresponding broach to allow 0.15mm press-fit either side of the implant.

Femoral Head AssemblyOnce the stem has been inserted, stability should be assessed one final time using the appropriate head trial. The selected femoral head implant is then inserted over the neck trunnion and impacted using the supplied head impactor before final reduction (fig. 8).

IMPLANT INSERTION

Figure 7

Figure 8

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IMPLANT DIMENSIONS- PARAGON AND COLLARED PARAGON

stem size

a/p width

(a)

m/l width

(b)

stem length

(c)

standard offset 130°

offset (d) neck height (e)-3.5 +0 +3.5 +7 -3.5 +0 +3.5 +7

1 9 22 100 29 32 35 37 24 26 28 31

2 9 23 102 31 34 37 39 25 27 29 32

3 9 25 104 33 36 39 41 25 27 29 32

4 9 26 106 33 36 39 41 26 28 30 33

5 9 27 108 35 38 41 43 27 29 31 34

6 9 29 110 35 38 41 43 28 30 32 35

7 9 30 112 37 40 43 45 29 31 33 36

8 9 32 114 37 40 43 45 30 32 34 37

9 9 33 116 39 42 45 47 31 33 35 38

10 9 34 120 41 44 47 49 32 34 36 39

11 9 36 124 41 44 47 49 33 35 37 40

12 9 37 128 43 46 49 51 34 36 38 41

stem size

a/p width

(a)

m/l width

(b)

stem length

(c)

high offset 130°

offset (d) neck height (e)-3.5 +0 +3.5 +7 -3.5 +0 +3.5 +7

1 9 22 100 35 38 41 43 24 26 28 31

2 9 23 102 37 40 43 45 25 27 29 32

3 9 25 104 39 42 45 47 25 27 29 32

4 9 26 106 39 42 45 47 26 28 30 33

5 9 27 108 41 44 47 49 27 29 31 34

6 9 29 110 41 44 47 49 28 30 32 35

7 9 30 112 45 48 51 53 29 31 33 36

8 9 32 114 45 48 51 53 30 32 34 37

9 9 33 116 47 50 53 55 31 33 35 38

10 9 34 120 49 52 55 57 32 34 36 39

11 9 36 124 49 52 55 57 33 35 37 40

12 9 37 128 51 54 57 59 34 36 38 41

Paragon™ Stem Standard Offset Dimensions

Paragon™ Stem High Offset Dimensions

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IMPLANT CATALOG

product code description

GM-80012-06-01 Paragon Stem- Standard HA- SZ 1













GM-80012-08-01 Paragon Stem- Offset HA- SZ 1











GM-80012-08-12 Paragon Stem-Offset HA- SZ 12



IMPLANT CATALOG


GM-80012-07-01 Paragon Stem Collared Size 1













GM-80012-09-01 Paragon Stem Collared Offset Size 1












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INSTRUMENT CATALOG

instrument product code diagram

OMNI Paragon Instrument Pan Tray 1 HS-99056

Paragon Trial Neck Std 1-3 GM-80013-22-00




Paragon Trial Neck High Offset 1-3 GM-80013-22-04




K1 Starting Rasp HS-65006

Paragon Broach Size 1 GM-80013-21-01












Paragon Stem Inserter GM-80013-11-00

Paragon Resection Guide GM-80013-01-00



INSTRUMENT CATALOG


OMNI Paragon Instrument Pan Tray 2 HS-99057

Calcar Planar Small XH-61113

Calcar Planar Large XH-61115

K1 Dual Offset 30° Left Broach Handle HS-65112

K1 Dual Offset 30° Right Broach Handle HS-65113

K1 Slap Hammer Weight HS-10024

Paragon Slap Hammer Adapter GM-80013-23-00

K1 Osteotome HS-10041

K1 Slap Hammer HS-10025

Starter Drill HS-62050

K1 Broach Handle HS-10054

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INSTRUMENT CATALOG


Sterilization Tray Open Pan 990003

Stem Offset Inserter HS-60030

Canal Opener- Lateralizer HS-60010

Paragon Stem Extractor HS-60015

Starter Reamer Small HS-10052 (ALTERNATE)

Starter Reamer Large HS-10051 (ALTERNATE)



Reorder No. HL-035 Rev 11/18 Copyright 2018. OMNIlife science, Inc. All rights reserved. Patents Pending.

OMNI, OMNIHIP, and OMNI K2 are trademarks of OMNIlife science, Inc.

480 Paramount DriveRaynham, MA 02767800-448-6664www.omnils.com

paragon™ surgical technique · the paragon™ hip stem can be inserted with equal ease using a...

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