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. 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 Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581-0988 USA Tel: +1 (800) 366 8143 Fax: +1 (574) 267 7196 www.depuy.com DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Tel: +44 (0)113 387 7800 Fax: +44 (0)113 387 7890 0086 DePuy International Ltd. and DePuy Orthopaedics, Inc. 2012. All rights reserved. 9068-84-052 version 3 Issued: 11/12 CA#DPEM/ORT/1112/0326
Enhanced Stability Constrained Liners Product Rationale & Surgical Technique
Contents Managing Stability 3 Cup Positioning 5 Surgical Technique 6 Product Information 9 Ordering Information 10
Managing Stability 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 THA 1. 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 caused 1 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 3
Managing Stability F A E B D C A Chamfered titanium alloy constraining ring provides ease of assembly and increased stability. D Poly slits and a flex groove for ease of head insertion. B Titanium alloy locking ring securely holds the liner into the PINNACLE cup to minimise potential disassembly. E Progressively larger ID sizes provide up to 112 range of motion. 10 C ARD (Anti-Rotational Device) tabs for rotational stability. F Ridge to aid in preventing constraining ring slippage. 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 4
Cup Positioning 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. 5
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. Liner to shell locking ring Head constraining ring 6
Surgical Technique 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. Chamfer 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. 7
Surgical Technique 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. 8
Product Information Potential ROM 10 Up to 112 Poly Thickness 10 (mm) 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 Poly Thickness 10 (mm) 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 6 High Offset Stem. 10 9
Ordering Information Implants +4 Neutral +4 10 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 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. Instruments Item Number Description* 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 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 10