Ceramic Bearings Should Be Routinely Used in THA. Disclosures 5/4/2015

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1 5/4/2015 Ceramic Bearings Should Be Routinely Used in THA Gwo-Chin Lee, MD Assistant Professor University of Pennsylvania Philadelphia, PA USA University of Pennsylvania Department of Orthopaedic Surgery Consultant Stryker Depuy Educational Honoraria Depuy Ceramtec Medtronic Research Support Zimmer Smith and Nephew NIH CD Diagnostics Cempra Pharmaceuticals Disclosures 1

2 5/4/2015 Newer Polyethylene Forgiving Reliable No wear (?) Good Enough! The Posterior Approach The Historical Concerns Most common reasons for revision: Instability/Dislocation : 22.5% Mechanical Loosening: 19.7% Infection: 14.8% TREND TOWARDS USING LARGE HEADS JBJS-A

3 5/4/2015 Volumetric Wear? Do we have the tools to measure wear? University of Pennsylvania Department of Orthopaedic Surgery Osteolysis Threshold 0.1 mm/yr (Dumbleton JH, J Arthroplasty 2002) Negative Wear? 3

4 5/4/2015 SMALL OSTEOLYTIC LESIONS (1CM) VISIBLE Today s Patients Younger More Active Obese Life expectancy will increase 4

5 5/4/2015 The Problem: Wear and Osteolysis 40 YO Female 7 years s/p THA We Can Do Better Ceramics University of Pennsylvania Department of Orthopaedic Surgery Resurgence of Ceramics Appetite for larger heads Increased number of head sizes, options, and reliability Trunionosis 5

6 5/4/2015 Wear characteristics are important Bragdon et al. 2006, Greenwald et al. 2006, Manning et al. 2005, Martell et al. 2003, Zichner et al. 1992, 1977 Hydrophilic Wetting of alumina ceramic (left) and metal (right) ball heads. The smaller the wetting angle the better the lubrication. Garino, JBJS, 2001 INERT AND BIOCOMPATIBLE 6

7 5/4/2015 Author Journal Year F/U Hips Survivorship Boyer Orthop Traumatol Surg Res y 83 92% Capello J Arthroplasty y % Mesko J Arthroplasty y % Kim Int Orthop y % Sugano J Arthroplasty y % Solarino Aldrian Silke J Orthop Traumatol y 68 97% Hip Internat y % Lewis J Arthroplasty y % Chevillotte Int Orthop y % Park Orthopedics y % Kress Int Orthop y 75 99% Yeung JBJS-A % D Antonio CORR y %/95.2% Mean 14.6 Years Follow Up 7

8 5/4/2015 Clinically Relevant Durability 100 Harris Hip Scores Pre-op 5 years 10 years 12.5 years Lee GC et al. Seminars in Arthroplasty 2014 COC vs MOP Author Year F/U COC MOP Capello y 95.9% 91.3% Mesko y 96.8% 92.1% Yoon y 81% 74.4% D Antonio % 91.3% Less Osteolysis and Less Measurable Wear 8

9 5/4/2015 Why not ceramics in everyone? Fewer options Risk of fracture Risk of squeaking Less forgiving Cost Author Year Hips Fractures Rate Squeaking Boyer liner 1.2% 1 (1.2%) Capello liners 0.5% 3 (0.8%) Mesko liners 1 head 0.9% 9 (2.7%) Kim % 2 (2%) Sugano liner 1% 0 (0%) Solarino % NR Aldrian Silke heads (extra long necks) 1.3% NR Lewis % 0 (0%) Chevillotte % 6 (6%) Park liners 1.7% 0 (0%) Kress % NR Yeung % 1 (0.3%) D Antonio % 2 (1%) 14 out of 2138 (0.6%) 9

10 Fr ) 1. Lehil MS, Bozic KJ. Trends in total hip arthroplasty implant utilization in the United States. J Arthroplasty 2014; 29(10): Fritsch EW, Gleitz M. Ceramic femoral head fractures in total hip arthroplasty. Clin Orthop Relat Res 1996; 328: Massin P, Lopes R, Masson B, et al. Does Biolox Delta reduce the rate of component fractures in total hip replacement? Orthop Traumatol Surg Res 2014; 100(6S):S317-S321. 5/4/2015 Incidence of Modern Alumina Ceramic and Alumina Matrix Composite Femoral Head Failures in Over 5.7 Million THA Gwo-Chin Lee, MD(1)(2-Ceramtec, 3B-Stryker, Depuy) and Raymond H. Kim, MD(2)(2-Ceramtec, Convatec, 3B-Stryker) 1- University of Pennsylvania, Philadelphia, PA, United States; 2- Colorado Joint Replacement, Denver CO Introduction While conventional total hip arthroplasty (MOP) have been shown to be durable and reliable, concerns remain. Improved wear properties, increased head and neck options, and concerns with trunionosis have led to an increasing utilization of ceramic ball heads (1). Concerns of ceramic fractures and increased implant costs remain the principal barriers to wide adoption of ceramics (2). Mating Surfaces (Forte) Ball head size greater than 28mm were significantly less likely to fracture compared to 28 mm ceramic ball heads (p<0.001) Objectives The purpose of this study is to evaluate the risk of ceramic ball head fracture through analysis of the quality control program of a major ceramic implant manufacturer. Goals: 1) Determine the fracture rate of modern 3 rd and 4 th generation alumina and alumina matrix composite ball heads 2) Determine the factors (timing, ball head size, and taper influence) on ceramic ball head fractures Materials and Methods Ceramtec (Plochingen, Germany) Reporting and Surveillance Program (1/1/ /31/2013) Mating Surfaces (Delta) Taper Influence Short taper 28mm ball head was more likely to fracture compared to other neck lengths (p<0.01). Taper mismatch at the root of significant number of delta ball head fractures (over 50%). Taper contamination also common in forte ball head fractures (over 50%). Discussion Manufacturer reported rates of fracture are lower compared to reported clinical fracture rates (2,3). Massin et al. reported 3 rd generation alumina fracture rates of 0.18% compared to % for 4 th generation alumina composite ball heads (3) 3.2 million pure alumina (Biolox forte) The reported fracture rate of ceramic ball heads have decreased over time 2.52 million alumina matrix composite balls (Biolox delta) 0.100% Analysis of reported failures with respect to time to failure, head size and other factors BIOL Reliability of Reporting 0.000% Reporting of ceramic component failures to Ceramtec by orthopaedic implant manufacturers mandated through contracts. Destructive analysis of retrieved implants including scanning electron microscopy (SEM) when permitted. Evaluation for taper compatibility, metal transfer, fracture crack propagation, and taper contamination. Fractures typically occur early during the implant s life of service Results Fourth generation alumina matrix composite ceramic ball heads were more reliable compared to 3 rd generation pure alumina ball heads 672 Biolox forte fractures (0.021%) 1 in Biolox delta fractures (0.001%) 1 in 100,000 Many factors leading to ceramic ball head fractures such as taper compatibility and contamination are under a surgeon s control. Limitations Reliability of reporting Numerator is unknown Look at the trends Small delta sample size Underpowered No surgical and clinical data No clinical correlation. Summary Alumina matrix composite ball heads are more reliable compared to pure alumina ball heads. Larger ball heads have lower risk for fractures. Taper mismatch and contamination greatly influence the reliability of ceramic ball head components. References Wear, Big Heads, Trunionosis 10

11 5/4/2015 Concessions Hard bearings are less forgiving Technically demanding Component position critical Liner insertion (chipping) Choices and Decisions Patient specific Clinically sound Economically responsible STANDARD: A level of quality or achievement that is considered desirable 11

12 5/4/2015 Ceramics Today Better wear More reliable More options Larger heads without concerns of wear Summary Recognition that there is a role and place for ceramic on ceramic hips in younger and active individuals. Ceramics has the lowest wear rates. Reliability of ceramics continually improving. Modern ceramic on ceramic THA have excellent clinical track record with low rates of complications. Thank You University of Pennsylvania Department of Orthopaedic Surgery 12

13 Ceramic Bearings Should be Routinely used in THA (Con) Thomas P. Schmalzried, M.D. Joint Replacement Institute at St. Vincent Medical Center Los Angeles, CA Harbor-UCLA Orthopaedics Disclosure Royalties received (DePuy) No royalties for any bearing Challenges for COC Overview Recognized low COC wear Metrics: Survivorship Function Special Risks Cost XLPE at 15 years Relative benefits and risks

14 Challenges for COC 2014 AOA NJR Survival of COC < XLPE Challenges for COC Function COC patient Comparable function Bearing surface material is not determinant of hip function Paris Marathon Challenges for COC Squeaking Sexton et al Younger patients Higher range of post-op. IR and ER Higher activity levels Position sensitive High acetabular inclination High femoral offset Lateralization of the hip center High or low acetabular component anteversion

15 Challenges for COC Overview Fractured COC Challenges for COC Revision for Fractured Ceramic Low survivorship Residual ceramic particles Hard 3 rd bodies Accelerated wear Osteolysis XLPE: 13 yrs, 37 Million Cycles 28, 32mm diam. mean linear penetration at min. 10 years mm/yr ( ) Mean volumetric wear 11.9mm 3 /year (range ) Max. linear penetration 0.87mm Max. volumetric wear = 435 mm 3 No radiographic osteolysis

16 Volumetric Wear (mm3) Decreasing Activity and Wear with Patient Aging The Osteolysis Threshold Max. linear penetration = 0.87mm Max. volumetric wear = 435 mm 3 No osteolysis observed in these hips Dowd et al. JBJS mm hips: No osteolysis at 10 yrs with linear wear rate <0.1mm/yr Corresponds to ~650mm 3 volumetric wear Decreasing Activity and Wear with Patient Aging Predicting Wear The First Five Years Mean volumetric wear rate = 15mm 3 /yr 40% mean decrease in wear from First 5 to 5-13 years Approximately a 3% compounded decrease in wear per year Life Expectancy for 50 yr old = 31.0 yrs Total volumetric wear over 31yrs = 305mm 3 Low risk of osteolysis during lifetime Osteolysis Threshold Wear Projection Years Post-op XLPE at 15 Years Bragdon et al Low wear No osteolysis Lower wear with time Lachiewicz et al Low wear Small osteolysis in 12 hips (14%) No association with head size or volumetric wear rate

17 Challenges for COC Summary Recognized low COC wear, BUT Survivorship is not better Function is not better Squeaking risk in target patients Fracture risk + low revision survival AND it costs more Relative benefits and risks favor XLPE

18 Indications for Ceramicised Metal Bearings in THR R.W. McCalden Associate Professor University of Western Ontario London Health Sciences Centre London, Ontario, CANADA Disclosures: Consultant for Smith & Nephew Institution receives research support from Smith & Nephew, J&J Depuy and Stryker What are the issues with THR in 2015? Fixation?? Surgical Approach?? Component Design?? Wear Trunnionosis!!! Bearing Surfaces!!!

19 Options To Hip Wear Change Poly (XLPE) Change counterface Ceramic OxZr Eliminate poly Ceramic-on-Ceramic Metal-on-Metal Except RSA Choosing A Bearing In THA What do I think about in a young active patient? Bearing Longevity/Osteolysis Potential Low taper corrosion potential? Which is best? Using XLPE is an Easy Choice Significant Difference (p<0.05) CONVENTIONAL XLPE Conventional y = x y = x y = x XLPE y = x

20 Australian Registry 2014 So far, HXLPE is a good thing!!! Gold Standard Polyethylene

21 Polyethylene Wear Related To Polyethylene Used (XLPE better) AND Counterface What are the options as a counterface for XLPE CoCr Ceramic Oxidized Zirconium (OxZr) What about CoCr heads? long history with THR most data with XLPE - excellent results to date inexpensive not scratch resistant potential for taper corrosion standard to compare against

22 Ceramic Oxide Oxidized Zirconium(OxZr) What is it? Zirconium metal component is heated in air Surface transforms to ceramic; not a coating Ceramic oxide is about 5 microns thick Oxygen Diffusion Air 500 o C Original Surface Oxygen Enriched Metal Metal Substrate Biocompatibility Zirconium: one of most biocompatible metals Ranked on passivation and biological response Other four: niobium, titanium, tantalum, platinum Zr-2.5Nb: metal alloy with niobium and oxygen IV B Ti Titanium (Ar) 3d 2 4s Zr Zirconium (Kr) 4d 2 5s 2 V B V Vanadium (Ar) 3d 3 4s Nb Niobium (Kr) 4d 4 5s *Kovacs and Davidson, ASTM STP 1272 Patients With Metal Allergies 3-8% No Nickel In Oxidized Zirconium

23 45 million cycle hip simulator wear test *Parikh et al., ORS 2013: million cycle hip simulator wear test *Parikh et al., ORS 2013:1028

24 45 million cycle hip simulator wear test *Parikh et al., ORS 2013:1028 Effect Of Roughened Heads On HXLPE Scratch Resistant Counterface Preferrable Oxidized Zirconium Metal Ceramic Maximizing hip bearing survivorship Abrasion Resistance OxZr resists scratching and maintains low wear conditions simulating in-vivo roughening from retrieved heads

25 Comparison of CoCr/CPE, OxZr/XLPE and Delta/XLPE simulator wear ~98% In Vitro evidence for OxZr is compelling. What is the clinical evidence?

26 Low clinical wear rates in hips* 400 patients 32 mm heads Martell method 3.7 yr median F/U 98% survivorship for all groups Penetration rates calculated relative to 1 yr radiographs *Jassim et al., ISTA, 2012:136 What is the best source of quality data about Bearing surfaces? Australian Registry Large numbers - Comparable implants to North America

27 Australian Registry 2014: OxZr/XLPE lowest Revision rate at 10 yrs OxZr against XLPE Australian Registry 2014: OxZr/XLPE lowest Revision rate at 10 yrs

28 Any downside to hard bearings? Hard Bearings (Ceramic & OxZr) can be damaged Damaged Ox head RWM Damaged ceramic head RWM How does this happen? Contact of femoral head against the edge of acetabular shell Care with final reduction!

29 What about Trunnionosis. How does OxZr technology help? Biocompatibility Key Factor in Trunnionosis Choice of head is critical to reduce taper corrosion Biocompatibility: Trunnionosis CoCr OxZr Ti6Al4V Ti6Al4V Less Taper corrosion after long term wear test with Oxinium heads (45 mcycles)

30 Retrieved OxZr heads show least chemical activity on the taper surface CoCrMo OxZr Ti transfer Cartner et al ORS 2014 Advantages of Ceramic heads against XLPE lower wear than CoCr scratch resistant reduced taper corrosion/fretting Disdvantages of Ceramic heads against XLPE expensive fracture potential limited modularity surface damage & metal transfer phase transformation possible

31 Advantages of OxZr heads against XLPE lower wear than CoCr - similar to ceramic scratch resistant fracture resistant maintains modularity reduced taper corrosion/fretting stable monoclinic phase excellent clinical results at 10 years Disdvantages of OxZr heads against XLPE expensive surface damage and/or metal transfer Indications for Ceramicised Metal Bearings in THR: excellent bearing choice for young active patients excellent in-vitro & in-vivo wear profiles ideal choice for metal allergy patients very resistant to taper corrosion & fretting

32 Indications for Ceramicised Metal Bearings in THR: OxZr - number of distinct advantages compared to ceramic heads - no risk of fracture - maintains modularity - stable ceramic phase - metal/ceramic - Best of both worlds OxZr/XLPE outstanding clinical results at 10 years Other Indications for Ceramicised Metal Bearings in THR: OxZr in the revision setting - fractured ceramic head - taper damaged & well-fixed stem - failed MOM THR (pseudotumour) - Rx of trunnionosis Ideally, should be used with compatible taper (ie same manufacturer) OxZr/XLPE provides an excellent bearing couple for THR OxZr/XLPE

33 OxZr/XLPE provides an excellent bearing couple for THR Thank You

34 5/4/2015 What we know About Trunions in 2015 Scott M. Sporer MD, MS Co-Medical Director, Cadence Health Joint Replacement Institute Central DuPage Hospital Associate Professor Department of Orthopaedic Surgery RUSH University Medical Center 1 Financial Disclosure Consultant: Zimmer, Smith & Nephew Royalties: Smith & Nephew Research Support: Zimmer, Cadence Health Royalties: SLACK Board: American Joint Replacement Registry 2 Modularity in THA Benefits of Head-Neck Modularity: Intra-operative flexibility Ability to change head at later date Decreased implant inventory Early concerns after introduction in 1980 s-1990 s Fretting and crevice corrosion 1 Collier, Clin Orthop Gilbert, JBMR Gilbert, JBJS(Am) 1994 Design improvements minimized corrosion, leading to near-universal adoption 4 1

35 5/4/2015 Modularity in THA Dual-taper stems Allow the surgeon to independently control femoral fixation and hip-center restoration o Modular necks allow adjustment of leg length, offset, and version 5 All Good Things Come To An End!! 6 Study Population 20 patients revised for ALTR secondary to corrosion between 1/2009 and 6/2012 Sex 16 women, 4 men Age 60.9 years (41 70) All metal-on-poly bearings 18 of 20 primary THA s performed at our institution (2 referrals) Cooper, HJ et al. J Bone Joint Surg Am. 2012;94(18):

36 5/4/2015 Study Population Initial presentation 3.9 years ( ) after index procedure Presenting symptoms included: pain (15) swelling / fluid collections (4) weakness (3) recurrent instability (7) Mean HHS score: 58.4 (22 79) 8 Components Study Population Femur Taper Junction Acetabulum VerSys Beaded Fullcoat (14) 12/14 Co-Co Trilogy VerSys Epoch Fullcoat (1) 12/14 Co-Co Trilogy Zimmer Multilock (1) 6 deg Ti-Co HG-2 VerSys Fiber Metal Taper (1) 12/14 Ti-Co Trilogy M/L Taper w Kinectiv Modular Neck (1) Head Sizes 28mm (5) 32mm (9) 36mm (5) 40mm or larger (1) 12/14 Ti-Co Trilogy AML Bantam (1) 10/12 Co-Co Trilogy Accolade (1) V40 Ti-Co Trident PSL 9 Diagnostic Workup 8 patients underwent cross-sectional imaging, each demonstrating large fluid collections around the hip 10 3

37 5/4/2015 Metal Levels Elevated Co levels in all but one case Elevated Cr levels in all but three cases Serum Co levels were differentially elevated (p = 0.014, Wilcoxon signed-rank test) over serum Cr levels Ion Mean Range Reference 1 Co ng/ml (0.16 ± 0.10) Cr 2.16 ng/ml (0.24 ± 0.35) 1 Jacobs, ORS Serum Cobalt Levels 12.0 Preop Serum Cobalt Ion Levels (ng/ml) Months Post-Op 13 4

38 5/4/2015 Modular Neck Study Cooper, HJ et al. J Bone Joint Surg Am. 2013;95: Multicenter, multi-surgeon series 11 patients (12 hips) revised for ALTR secondary to corrosion between 12/2010 and 6/2012 Sex 8 women, 3 men Age 60.1 years (43 77) Bearing: Metal-on-Poly (4) Ceramic-on-Poly (8) Single stem design (Rejuvenate) Titanium alloy (TMZF) stem Cobalt chromium alloy neck 14 Study Population Initial presentation 7.9 months (5 13) after index procedure Presenting symptoms included: groin pain (11) buttock pain (5) trochanteric pain (4) thigh pain (3) limp / weakness (4) thigh swelling (1) Mean HHS score: 43.2 (22 71) 15 Diagnostic Workup: MRI 10 of 12 hips imaged with MARS MRI Large fluid collections with hypertrophic soft tissue reactions in 9 of 10 patients Images interpreted as normal in 1 patient (Coronal STIR image) 16 5

39 5/4/2015 Metal Levels Obtained in 10 of 12 hips Serum Co levels were differentially elevated over serum Cr levels Ion Mean Range Reference 1 Elevation Ti 3.41 ng/ml ( ) 0.8 x Co 5.99 ng/ml ( ) 18.7 x Cr 0.61 ng/ml ( ) 2.3 x 1 Jacobs, JBJS Etiology of ALTR Related to summation of debris released from bearing surfaces and modular taper junctions through tribocorrosion mechanisms ALTR only reported in association with modular junctions involving a CoCr alloy component Have yet to be reported in association with Ti-Ti alloy junctions o Titanium necks are more susceptible to fracture Potentially contributing factors from modularity: Head size Taper geometry Material composition Extended offset neck Contamination of the taper interface (assembly issues) Design-related factors (manufacturer dependent) Alloy (TMZF) 20 6

40 5/4/2015 Synergistic Effects Tribocorrosion (combined corrosion and wear) Third Body Effects Cathodic Polarization Effects (electrical connectivity between tribocorrosive processes at bearing surface and modular junctions) Sum of metal debris burden from bearing surfaces (McKellop Mode 1 wear) and modular junctions (Mode 4 wear) 21 Relevance for MoM Consider modular taper tribocorrosion as a cause/contributor to ALTR in patients with MoM bearings, particularly if Co is elevated out of proportion to Cr (Garbuz CORR [2010] 468: ). Volumetric wear from tribocorrosion at modular connections can exceed that from the bearing surface (Langton et. al. Bone Joint Res [2012] 1:56 63). 22 Relevance for MoM In modular acetabular components with metal on metal bearings simple acetabular liner exchange may not address the primary debris generator the trunion should also be carefully assessed. 23 7

41 5/4/2015 Questions I Would Like To Know Do Large Femoral Heads Make A Difference? Does the Trunion Design Matter? Are Taper debris particles more bioreactive than articular surface particles? Should I be using a ceramic head on everyone? Is there a threshold Cobalt and/or Chromium level to be concerned? Do patients with Cobalt/Chrome heads need different surveillance? Is Changing the head and liner adequate treatment? 24 Femoral Head Size 69 Patients Metal on Poly Cementless Hip Patients cobalt and chromium levels 12 patients 28 mm, 18 patients 36 mm, 13 patients 40 mm Increased Cobalt levels 36 mm Normal Chromium levels Craig, P.; Bancroft, G.; Burton, A.; Collier, S.; Shaylor, P.; and Sinha, A.: Raised levels of metal ions in the blood in patients who have undergone uncemented metal-onpolyethylene Trident-Accolade total hip replacement. Bone Joint J, 96(1): Trunion Design 40 retrieved MOM heads Graded for fretting and corrosion Head Diameter did not correlate with fretting Trunion diameter and engagement length important Head/Neck Corrosion correlated with soft tissue loss Nassif NA, Nawabi DH, Stoner K, Elpers M, Wright T, Padgett DE. Taper Design Affects Failure of Large-head Metal-on-metal Total Hip Replacements. Clin Orthop Relat Res

42 5/4/2015 Trunion Design 161 failed MOM components Head 128 Stem 33 Female taper noted to have ridges Imprinting (Ridged microthread introduced to minimize burst of ceramic heads) Corrosion primarily in area of imprinting Corrosion and Imprinting scores related Hexter A, Panayiotidou A, Singh J, Skinner J, Hart A. Mechanism of corrosion in large diameter head metal-on-metal total hip arthroplasty: a retrieval analysis of 161 components. Bone Joint J. 2013:95 B Supp 12, Trunion vs. Articular Particles 369 MOM bearings Revised for ARMD THA patients compared to Resurfacing Resurfacing explants revised for ARMD higher volumetric wear than THA Combined volumetric bearing + taper wear in THA revisions still less than resurfacing Tissue destruction and extent of ALVAL greater in THA Taper particles more bioreactive Langton D, Sidaginamale R, Lord J, Joyce T, Natu S, Nargol A. Metal debris release from taper junctions appears to have a greater clinical impact than debris released from metal on metal bearing surfaces. Bone Joint J. 2012:95 B Supp Clinical Questions Should I be using a ceramic head on everyone? Is there a threshold Cobalt and/or Chromium level to be concerned? Do patients with Cobalt/Chrome heads need different surveillance? Is Changing the head and liner adequate treatment? 29 9

43 5/4/2015 THANK YOU 30 10