enhanced stability constrained linerssynthes.vo.llnwd.net/o16/llnwmb8/int mobile/synthes...surg....

12
References 1. Sanchez-Sotelo J, Haidukewych GJ, Boberg CJ. Hospital Cost of Dislocation After Primary Total Hip Arthroplasty. J Bone Joint Surg. 2006;88A:290-294. 2. Brodner W, Grübl A, Jankovsky R, Meisinger V, Lehr S, Gottsauner-Wolf FJ. Cup inclination and serum concentration of cobalt and chromium after metal-on-metal total hip arthroplasty. J Arthroplasty. 2004;19(8 Suppl 3):66-70. 3. Williams S, Leslie I, Isaac G, Jin Z, Ingham E, Fisher J. Tribology and wear of metal-on-metal hip prostheses: influence of cup angle and head position. J Bone Joint Surg. 2008;90A Suppl 3:111-7. 4. Udomkiat P, Dorr LD, Wan Z. Cementless hemispheric porous-coated sockets implanted with press-fit technique without screws: average ten-year follow-up. J Bone Joint Surg. 2002;84A:1195-200. 5. Schmalzried TP, Guttmann D, Grecula M, Amstutz H. The relationship between the design, position, and articular wear of acetabular components inserted without cement and the development of pelvic osteolysis. J Bone Joint Surg. 1994;76A:677-688. 6. Kennedy JG, Rogers WB, Soffee KE, et al. Effect of acetabular component orientation on recurrent dislocation, pelvic osteolysis, polyethylene wear and component migration. J Arthroplasty 1998;13:530-534. 7. Prudhommeaux F, Hamadouche M, Nevelos J, et al. Wear of alumina-on-alumina total hip arthroplasty at a mean 11-year followup. Clin Orthop. 2000; 397:113. 8. Walter WL, O’Toole GC, Walter WK, Ellis A, Zicat BA. Squeaking in ceramic-on-ceramic hips: the importance of acetabular component orientation. J Arthroplasty. 2007;22:496-503. 9. Tower SS, Currier JH, Currier BH, Lyford KA, Van Citters DW, Mayor MB. Rim cracking of the cross-linked longevity polyethylene acetabular liner after total hip arthroplasty. J Bone Joint Surg Am. 2007 Oct;89(10):2212-7. 10. Pinnacle Constrained Liner Design History File (Project No. 452-407-013) 2006. 9068-84-052 version 3 Issued: 11/12 0086 DePuy International Ltd St Anthony’s Road Leeds LS11 8DT England Tel: +44 (0)113 387 7800 Fax: +44 (0)113 387 7890 DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581-0988 USA Tel: +1 (800) 366 8143 Fax: +1 (574) 267 7196 This publication is not intended for distribution in the USA. DePuy Orthopaedics EMEA is a trading division of DePuy International Limited. Registered Office: St. Anthony’s Road, Leeds LS11 8DT, England Registered in England No. 3319712 ©DePuy International Ltd. and DePuy Orthopaedics, Inc. 2012. All rights reserved. www.depuy.com CA#DPEM/ORT/1112/0326

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Page 1: Enhanced Stability Constrained Linerssynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes...Surg. 2002;84A:1195-200. 5. Schmalzried TP, Guttmann D, Grecula M, Amstutz H. The relationship

References

1. Sanchez-Sotelo J, Haidukewych GJ, Boberg CJ. Hospital Cost of Dislocation After Primary Total Hip Arthroplasty. J Bone Joint Surg. 2006;88A:290-294.

2. Brodner W, Grübl A, Jankovsky R, Meisinger V, Lehr S, Gottsauner-Wolf FJ. Cup inclination and serum concentration of cobalt and chromium after metal-on-metal total hip arthroplasty. J Arthroplasty. 2004;19(8 Suppl 3):66-70.

3. Williams S, Leslie I, Isaac G, Jin Z, Ingham E, Fisher J. Tribology and wear of metal-on-metal hip prostheses: infl uence of cup angle and head position. J Bone Joint Surg. 2008;90A Suppl 3:111-7.

4. Udomkiat P, Dorr LD, Wan Z. Cementless hemispheric porous-coated sockets implanted with press-fi t technique without screws: average ten-year follow-up. J Bone Joint Surg. 2002;84A:1195-200.

5. Schmalzried TP, Guttmann D, Grecula M, Amstutz H. The relationship between the design, position, and articular wear of acetabular components inserted without cement and the development of pelvic osteolysis. J Bone Joint Surg. 1994;76A:677-688.

6. Kennedy JG, Rogers WB, Soffee KE, et al. Effect of acetabular component orientation on recurrent dislocation, pelvic osteolysis, polyethylene wear and component migration. J Arthroplasty 1998;13:530-534.

7. Prudhommeaux F, Hamadouche M, Nevelos J, et al. Wear of alumina-on-alumina total hip arthroplasty at a mean 11-year followup. Clin Orthop. 2000; 397:113.

8. Walter WL, O’Toole GC, Walter WK, Ellis A, Zicat BA. Squeaking in ceramic-on-ceramic hips: the importance of acetabular component orientation. J Arthroplasty. 2007;22:496-503.

9. Tower SS, Currier JH, Currier BH, Lyford KA, Van Citters DW, Mayor MB. Rim cracking of the cross-linked longevity polyethylene acetabular liner after total hip arthroplasty.J Bone Joint Surg Am. 2007 Oct;89(10):2212-7.

10. Pinnacle Constrained Liner Design History File (Project No. 452-407-013) 2006.

9068-84-052 version 3 Issued: 11/12

0086

DePuy International LtdSt Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (0)113 387 7800Fax: +44 (0)113 387 7890

DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581-0988USATel: +1 (800) 366 8143Fax: +1 (574) 267 7196

This publication is not intended for distribution in the USA.

DePuy Orthopaedics EMEA is a trading division of DePuy International Limited.Registered Offi ce: St. Anthony’s Road, Leeds LS11 8DT, EnglandRegistered in England No. 3319712

©DePuy International Ltd. and DePuy Orthopaedics, Inc. 2012. All rights reserved.

www.depuy.com

CA#DPEM/ORT/1112/0326

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Product Rationale & Surgical Technique

Enhanced Stability Constrained Liners

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Contents

Managing Stability 3

Cup Positioning 5

Surgical Technique 6

Product Information 9

Ordering Information 10

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3

The DePuy portfolio offers a continuum of products to address

hip instability. The PINNACLE® Acetabular Cup System includes:

Enhanced Stability Constrained Liners

• High strength head capture

• May be used with uni-polar or bi-polar heads

• +4 Neutral and +4 10° options

• The liners are made of GVF polyethylene

• 28, 32, 36, 40, 44 mm IDs

Managing Instability

Hip instability and dislocation are uncommon yet significant

issues with THA1. A bearing system that provides multiple

options is important in helping surgeons address and minimise

instability. The PINNACLE Acetabular Cup System offers

lateralised, face changing, lipped, large inner diameter and

constrained liners, giving surgeons the power to choose a

solution that meets each of their intraoperative needs.

Managing hip stability can be challenging, as there may be

multiple causes acting either independently or in tandem. These

include:

• Soft tissue or bony impingement

• Mechanical impingement of the prosthetic components

caused1 by suboptimal positioning

• Soft tissue laxity

Managing Cost of Dislocation

Dislocation after primary hip replacement continues to be a

prevalent procedure and usually requires the use of expensive

hospital resources or even revision surgery.1

The treatment of dislocation diminishes the cost-effectiveness

of an otherwise very successful surgical procedure and causes

substantial costs to the hospital and the society. 1

Prevention of dislocation after hip arthroplasty is critical not

only to minimise patient morbidity but also to maintain the

cost-effectiveness of this surgical procedure.1

Managing Stability

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By understanding the causes of instability and the number of options available to address them within the PINNACLE system, the

goal of a more stable construct can be addressed in several ways.

It is important to understand the trade-offs associated with the various options and the appropriate indications for use.

Available in +4 neutral / +4 10°

• Lateralises head centre

• Redirects articulation of available range of motion

Chamfered titanium alloy constraining ring provides

ease of assembly and increased stability.

ARD (Anti-Rotational Device) tabs for rotational stability.

Titanium alloy locking ring securely holds the liner into

the PINNACLE cup to minimise potential disassembly.

A

B D

E

F

C

A

B

Ridge to aid in preventing constraining ring slippage.

Progressively larger ID sizes provide up to 112° range of

motion.10

E

FC

Poly slits and a flex groove for ease of head insertion.D

4

Managing Stability

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5

Peer reviewed publications highlight the importance of acetabular component

positioning in relation to short and long term outcomes during total hip

arthroplasty for all types of bearing materials.2-9

Cup positioning should be varied to optimise fixation, range of motion

and dislocation resistance and minimise the likelihood of subluxation,

impingement and edge loading. This may be assessed during pre-operative

planning, acetabular preparation and cup trialling. Sub-optimal component

positioning may lead to edge loading, dislocation, increased wear, elevated

metal ion release, ceramic squeaking and polyethylene fracture.2-9

The target cup inclination (as measured on radiographs) should be 40-45°

taking into account local soft tissue and anatomic landmarks. The target

cup anteversion (as measured on radiographs) should be 15-20° taking into

account local soft tissue and anatomic landmarks.

An alignment guide is provided to assist with cup positioning; however, cup

orientation in the patient depends on patient position. The alignment guide

does not allow for variation in patient position with respect to the operating

table and it should be noted that patient orientation can vary throughout the

procedure.

Cup Positioning

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Liner to shelllocking ring

Headconstraining

ring

6

Surgical Technique

Note: trials are available and should be used

prior to implanting

STEP 1

Insert the PINNACLE primary or PINNACLE revision

cup as per the PINNACLE Cup System Surgical

Technique (9068-50-050).

STEP 2

Utilise peripheral and/or dome screws as needed

to securely fix the cup in place. Irrigate and clean

the inside of the cup to ensure it is free of debris.

STEP 3

Following insertion of the final acetabular cup and

femoral component, the trial inserts can be used

in the cup to confirm insert selection and evaluate

joint stability and range of motion.

STEP 4

Seat the constrained liner into the PINNACLE cup

and align the ARD (anti-rotation device) tabs. The

pre-assembled locking ring is designed to fit into

the groove around the inner circumference of the

PINNACLE cup.

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Chamfer

7

STEP 5

Utilising an impactor tip one size smaller than

the ID of the liner to be impacted, seat the

constrained liner into the cup. The top of the

ARDs should be flush with the polished face of

the PINNACLE cup.

STEP 6

Place the chamfered constraining ring over the

neck of the implant in the correct orientation. The

chamfered edge of the constraining ring should

be facing the acetabular cup.

STEP 7

With the femoral head implanted onto the stem,

reduce the femoral head and lock the constraining

ring onto the face of the constrained liner.

Note: Do not insert a trial femoral head into

the constrained liner, as it will be difficult to

remove.

Note: If deemed necessary, use the PINNACLE

ring inserter handle to facilitate the handling

of the constraining ring. Assemble the

appropriate ring inserter (size related) onto

the handle and then snap the constraining

ring into the inserter. With slight pressure,

the ring will be seated onto the constrained

liner. The curve of the handle facilitates force

application, as the curve places the handle

directly above the centre of the ring.

Surgical Technique

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8

STEP 8

Verify complete assembly of the construct, and

review the range of motion to ensure appropriate

component placement was achieved.

STEP 9a

If removal of a PINNACLE constrained liner is

necessary, the use of the extractor tip will be

helpful: Assemble the extractor tip to the straight

PINNACLE impactor. The tip can be screwed onto

all available impactors of the PINNACLE system.

STEP 9b

Place the extractor tip into an empty ARD

(Anti-Rotation Device) to lever the constrained

liner out of the cup. Several attempts through

different ARDs might be necessary to enable the

release of the liner.

Surgical Technique

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9

Product Information

Liner Size ID Size Dome 45˚ ROM*

28 x 48 28 9.6 8.2 89˚

28 x 50 28 10.6 9.3 89˚

32 x 52 32 9.6 8.3 96˚

32 x 54 32 10.6 9.2 96˚

36 x 56 36 9.7 8.3 104˚

36 x 58 36 10.4 9.1 104˚

36 x 60 36 11.2 9.8 104˚

40 x 62 40 9.9 8.6 109˚

Potential ROM10

Up to 112˚

Liner Size ID Size Dome 45˚ ROM*

40 x 64 40 10.6 9.3 109˚

40 x 66 40 11.4 10.1 109˚

40 x 68 40 12.2 10.8 109˚

44 x 70 44 1.2 9.8 112°

44 x 72 44 12.1 10.8 112°

44 x 74 44 13.2 11.8 112°

44 x 76 44 14.2 12.9 112°

*Range of Motion (ROM) as shown here describes a sweep angle, tested with +4 Neutral Liners and a 12/14 Taper DePuy SUMMIT® POROCOAT® Size 6High Offset Stem.10

Poly Thickness10 (mm) Poly Thickness10 (mm)

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10

Ordering InformationImplants

Description

Item Number Trial Number ID OD

1218-28-648 2218-28-648 28 48

1218-28-650 2218-28-650 28 50

1218-32-652 2218-32-652 32 52

1218-32-654 2218-32-654 32 54

1218-36-656 2218-36-656 36 56

1218-36-658 2218-36-658 36 58

1218-36-660 2218-36-660 36 60

1218-40-662 2218-40-662 40 62

1218-40-664 2218-40-664 40 64

1218-40-666 2218-40-666 40 66

1218-40-668 2218-40-668 40 68

1218-44-670 2218-44-670 44 70

1218-44-672 2218-44-672 44 72

1218-44-674 2218-44-674 44 74

1218-44-676 2218-44-676 44 76

Description

Item Number Trial Number ID OD

1218-28-748 2218-28-748 28 48

1218-28-750 2218-28-750 28 50

1218-32-752 2218-32-752 32 52

1218-32-754 2218-32-754 32 54

1218-36-756 2218-36-756 36 56

1218-36-758 2218-36-758 36 58

1218-36-760 2218-36-760 36 60

1218-40-762 2218-40-762 40 62

1218-40-764 2218-40-764 40 64

1218-40-766 2218-40-766 40 66

1218-40-768 2218-40-768 40 68

1218-44-770 2218-44-770 44 70

1218-44-772 2218-44-772 44 72

1218-44-774 2218-44-774 44 74

1218-44-776 2218-44-776 44 76

+4 Neutral +4 10˚

Item Number Description*

2217-50-041 Straight Impactor

2217-50-005 26 mm Impactor Tip

2217-50-006 28 mm Impactor Tip

2217-50-007 32 mm Impactor Tip

2217-50-008 36 mm Impactor Tip

2217-50-060 40 mm Impactor Tip

*Use an impactor tip one size smaller than the ID of the liner

Instruments

Item Number Description

2218-00-020 PINNACLE Cons Ring Handle

2218-00-028 28 mm PINNACLE Cons Ring Inserter

2218-00-032 32 mm PINNACLE Cons Ring Inserter

2218-00-036 36 mm PINNACLE Cons Ring Inserter

2218-00-040 40 mm PINNACLE Cons Ring Inserter

2218-00-044 44 mm PINNACLE Cons Ring Inserter

2218-00-010 PINNACLE Liner Extractor Tip

Further sizes are available for 32 mm ID Constrained Inserts (1218-32-656 to 1218-32-676) for cup sizes up to 76 mm OD. To prevent

dislocation and maximise ROM as much as possible, the use of the largest possible head size per cup size is recommended.