PARAGON™ ANTERIOR APPROACH SURGICAL …...broaching periodically withdraw the broach to help clear the broach teeth of bone fragments. Advance the cutting teeth of the selected broach

PARAGON™ ANTERIOR APPROACH SURGICAL TECHNIQUE

1 Table of Contents

2 Indications & Contraindications

3 Surgical Technique at a Glance

4 Pre-operative Planning

5 Surgical Technique

6 Preparation of the Femur

10 Femoral Component Insertion

11 Femoral Head

12 Implant Dimensions

13 Implant Catalog

15 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 | PAR AGON ANTERIOR APPROACH S U R G I C A L T EC H N I Q U E

PARAGON ANTERIOR APPROACH

INDICATIONS & CONTRAINDICATIONS

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.

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SURGICAL TECHNIQUE AT-A-GLANCE

Femoral neck resection. Femoral canal preparation. Femoral canal opening-starter rasp

Broaching. Trial reduction. Femoral component insertion.

Femoral head assembly.



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5

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6

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 (frog leg lateral). It is recommended to use a radiographic marker or scale.

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

Determine the 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 will be determined intra-operatively. Templating is for planning purposes only.

PREOPERATIVE PLANNING

Figure 1



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

This technique is specifically for implanting the Paragon™ Hip Stem using an Anterior or Direct Anterior approach. Position the patient supine on a fluoroscopy-capable table. The O.R. table must be able to extend at the hip and the hip must be positioned to permit fluoroscopic viewing. There are a number of options available to the surgeon to assist with exposure including traction table attachments and table mounted retractors.

Surgical ExposureSurgical exposure will depend on which surgical method is selected. Retractors are provided with the Paragon system specifically for Anterior and Direct Anterior approach (reference page 19); however, their selection, placement, and use is based on surgeon preference as to which exposure method they select. Additional surgical tools not specific to the Paragon system may also be used by the surgeon to assist with exposure. These tools, such as table-mounted retractors, may be supplied by the hospital or another third party.

SURGICAL TECHNIQUE

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Femoral Neck ResectionOnce exposure through the joint capsule is achieved via the chosen Anterior approach, insert the Corkscrew Head Remover into the femoral head (fig. 5). Using this and distraction forces (either manual or mechanically-assisted), dislocate the femoral head.

Then, using preoperative radiographs as a guide, resect the femur in the desired location and orientation. Note that the angle of the osteotomy cut is 45 degrees to the long axis of the femur.

Locate the inferior lesser trochanter, and determine the correct length for the neck resection.

Note: The Anterior approach makes it difficult to perform a second or finishing resection so take care to make the first resection correctly.

During femoral head removal, use retractors to protect the tensor from sharp fragments on the resected femoral neck.

Acetabulum PreparationAfter the femoral neck osteotomy is complete, prepare and implant the acetabular components.

PREPARATION OF THE FEMUR

Figure 5


PARAGON ANTERIOR APPROACH 1

Femoral Canal PreparationPalpate the vastus tubercle and place the bone hook distal to the vastus tubercle on the posterior side of the femur. Externally rotate the femur, and apply force to the bone hook to elevate the proximal femur and allow visualization.

Take care when applying force during external rotation, especially on osteoporotic patients, since forces can result in fractures.

Release the lateral capsule anterior to posterior from inside the greater trochanter towards the piriformis fossa. Performing releases to the capsule to the medial trochanter tip will further increase exposure.

Use a Long Rongeur to remove lateral neck material from the resection.

Open the proximal femur to the piriform fossa by using the offset osteotome (fig. 6).

Figure 6


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Femoral Canal OpeningEmploy the starter rasp to identify the intramedullary canal of the proximal femur working laterally and posteriorly (fig. 7). Ensure that the Starter Reamer is aligned axially within the femoral canal, using femoral landmarks and the knee as guides.

Use Rongeur to remove any overhanging bone fragments from the greater trochanter, since these may interfere with broaching and send the broaches varus, or through the lateral wall of the femoral canal.

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.


Figure 7

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BroachingStart with the smallest broach, attaching it to the Anterior Broach handle (fig. 8). During broaching periodically withdraw the broach to help clear the broach teeth of bone fragments.

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 ensure 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.


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Figure 8

FEMORAL COMPONENT INSERTION

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

The modular trial necks slide onto the post on the proximal end of the broach. Select the trial neck based on preoperative 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. 9).

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.

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. 10).

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

Figure 9

Figure 10

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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. 11).

FEMORAL HEAD

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Figure 11

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

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

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IMPLANT CATALOG


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













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














INSTRUMENT CATALOG

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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



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)

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INSTRUMENT CATALOG

instrument product code drawing alternate code alternate drawing qty per set diagram

Anterior Approach Hip Pan Common

InstrumentsHS-65002 2325-00 1

Fem Neck/Post Acet Retractor- A

HS-20011 21137 X693-00 X693-00 3

Blunt Retractor- C HS-20012 21141 KX-06720 X744-00 2

Acet Winged Retractor left- B

HS-65100 21139-01 1

Acet Winged Retractor right- B

HS-65101 21139-02 1

Corkscrew Head Remover

HS-65200 20890 1

MAMBO- Femoral Elevator- E

HS-20010 21136 HS-20009 2200-00 2



INSTRUMENT CATALOG

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instrument product code drawing alternate code alternate drawing qty per set diagram

Mueller- Medial Calcar Retractor- D HS-20013 3261-00 HS-20007 X687-00 1

Canal Finder HS-65003 2326-00 1

Tapered Reamer HS-65004 2327-00 1

Side-biting Reamer HS-65007 2340-00 HS-65005 2328-00 1

T-Handle HS-10067 2431-00 621005HS-10060

800-0001635-00 1

Adapter Female Zim-mer to Male Hudson

HS-10065 2425-00 HS-10059611002

09-058-0002943

778-001

Reorder No. HL-040 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™ ANTERIOR APPROACH SURGICAL …...broaching periodically withdraw the broach to help clear the broach teeth of bone fragments. Advance the cutting teeth of the selected broach

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