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Joint Replacement: The Current and Future Impact of Coatings

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The control of surface properties to reduce wear and corrosion and improve biocompatibility is of particular interest today as device companies—and surgeons, payors and patients—seek to extend the life of knee and hip implants. In this session, device companies shared research on their joint replacement coatings and materials, covering pros, cons and the future of their technology.

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Joint Replacement: The Current and Future Impact of Coatings

  1. 1. Supporting healthcare professionals for over 150 years Supporting healthcare professionals for over 150 years Gordon Hunter, Ph.D. OMTEC: June 12, 2019 Articular Surface Enhancement for Joints (featuring OXINIUM™ Technology) ◊Trademark of Smith & Nephew
  2. 2. Polyethylene Wear in the Knee • Loosening and wear can limit long-term survivorship1 1Sharkey PF, Lichstein PM, Shen C, Tokarski AT, Parvizi J. Why Are Total Knee Arthroplasties Failing Today – Has Anything Changed After 10 Years? J Arthroplasty. 2014;29;1774-1778.
  3. 3. Sliding Wear Mechanisms • Adhesive (friction) • Abrasive (roughness)
  4. 4. CoCr Wear Issues • Abrasive and oxidative wear roughen CoCr –Bone cement –Bone –Fretting debris –Shed in-growth particles • Clinically observed scratches can increase wear1 Peak Condyle Surface Valley Knee3Hip2 1Fisher J, Firkins P, Reeves EA, Hailey JL, Isaac GH. The influence of scratches to metallic counterfaces on the wear of ultra-high molecular weight polyethylene. Proc Inst Mech Eng H. 1995;209(4):263-264. 2Barrack RL, Castro FP, Szuszczewicz ES, Schmalzried TP. Analysis of Retrieved Uncemented Porous-Coated Acetabular Components in Patients With and Without Pelvic Osteolysis. Orthopedics. 2002;25(12):1373-1378. 3Levesque M, Livingston BJ, Jones WM, Spector M. Scratches on condyles in normal functioning total knee arthroplasty. Paper presented at 44th Annual Meeting of the ORS, New Orleans, LA, 1998.
  5. 5. Ceramic as an Alternative to Metal • Hard surface resists roughening1-4 –Low articular abrasion –Low articular friction • Brittle material has limitations –Risk for chipping or breaking1 –Part geometry restrictions2 Zirconia Toughened Alumina3 Zirconia Toughened Alumina4 1Tateiwa T, Clarke IC, Williams PA, et al. Ceramic Total Hip Arthoplasty in the United States: Safety and Risk Issues Revisited. AM J Orthop. 2008;37(2):E26-E31. 2Skinner HB. Ceramic Bearing Surfaces. Clin Orthop Relat Res. 1999;369:83-91. 3Heiner AD, Mahoney CR. Fracture of a BIOLOX Delta Ceramic Femoral Head Articulating Against a Polyethylene Liner. JBJS Case Connect. 2014;4:e97. 4Krueger AP, Singh G, Beil FT, et al. Ceramic Femoral Component Fracture in Total Knee Arthroplasty: An Analysis Using Fractography, Fourier-Transform Infrared Microscopy, Contact Radiography and Histology. J Arthroplasty. 2014;29:1001-1004.
  6. 6. Ceramic Coatings to Enhance Metals • Surface is hard, but may not be effective –Limited durability with adhesion and/or cohesion1 –Wear may not be less than with metal (CoCr)2 Metal Substrate Original Surface Ceramic Deposition Ceramic Coating New Surface TiNbN Coating Worn Off 1Hunter G, Pawar V, Salehi A, Long M. Abrasive wear of modified CoCr and Ti-6AL-4V surfaces against bone cement. Medical Device Materials. S. Shrivastava (ed.), ASM International, Materials Park, OH. 2004;97-97. 2Haider H, Weisenburger JN, Croson RE, Namavar F, Garvin KL. Concern with adhesion and wear of a Titanium Niobium Nitride coating on Total Knee Replacements for metal sensitive patients. Poster presented at 54th Annual Meeting of the ORS, 1998, Poster No. 2007.
  7. 7. Oxidation of Zirconium Alloy • Wrought zirconium alloy metal device is heated in air • Surface transforms to stable ceramic (~5 µm); not coated1 • Oxide is durable and low-friction with toughness of metal1 Metal Substrate Oxygen Enriched Metal Original Surface Air 500oCOxygen Diffusion Ceramic Oxide Oxygen Enriched Metal Zr-2.5%Nb Alloy 1Hunter G, Dickinson J, Herb B, Graham R. Creation of Oxidized Zirconium Orthopaedic Implants. J ASTM Intl. 2005;2(7):1-14.
  8. 8. High Integrity and Stable Oxide Surface • Improved durability over passive oxide –Over 400X thicker than CoCr passive oxide –“Brick-like” structure perpendicular to surface –No pores or segregation internally or at interface –No line-of-sight limitation Ceramic Oxide Metal Alloy Rectangular Monoclinic Crystals of Zirconia TEM Image1 1Hobbs LW, Rosen VB, Mangin SP, Treska M. Oxidation Microstructures and Interfaces in the Oxidized Zirconium Knee, Intl J Appl Ceram Technol. 2005;2(3):221- 246.
  9. 9. Less Polyethylene Wear in Laboratory Simulators • Reduces wear rate under typical and severe conditions –Hip Simulator Example1 -Knee Simulator Example2 1Parikh A, Morrison M, Jani S. Wear testing of crosslinked and conventional UHMWPE against smooth and roughened femoral components. Abstract presented at 53rd Annual Meeting of the ORS, San Diego, CA, 2013. Paper No. 0021. 2Ezzet KA, Hermida JC, Patil S, et al. Wear of polyethylene against metal-ceramic composite femoral component: effect of aggressive kinematic conditions. Poster presented at 51st Annual Meeting of the ORS, 2006. Poster No. 1239.
  10. 10. Extensive Clinical Experience • Over 20 years of clinical use –First total knee in Dec. 1997; over 1,200,000 sold –First total hip in Oct. 2002; over 700,000 sold
  11. 11. 1 Review of Long-term Survival (2017) 1Civinni R, Matassi F, Carulli C, et al. Clinical Results of Oxidized Zirconium Femoral Component in TKA. A Review of Long-Term Survival. HSS Journal. 2017;13:32-34.
  12. 12. Fewer Clinical Knee Wear Features • Produced lower wear scores for both surfaces in 1-3 year retrieval study1,2 –Retrieved component pairs matched for time and patient factors –Femurs 92% fewer features; inserts 31% fewer features –Roughness measured by non-contact profilometry; all parameters were less CoC r OxZ r 1Heyse TJ, Elpers ME, Nawabi DH, Wright TM, Haas SB. Oxidized Zirconium versus Cobalt-Chromium in TKA: Profilometry of Retrieved Femoral Components. Clin Orthop Relat Res. 2014;472:277-283. 2Heyse TJ, Chen DX, Kelly N, et al. Matched-pair total knee arthroplasty retrieval analysis:Oxidized zirconium vs. CoCrMo. The Knee. 2011;18:448-452.
  13. 13. Unsurpassed Survivorship in Hips • OXINIUM/XLPE hips achieved 96.5% survivorship at 10 years1 “… the Registry urges caution in the interpretation of this result. This bearing is a single company product, used with a small number of femoral stem and acetabular component combinations. This may have a confounding effect on the outcome, making it unclear if the lower rate of revision is an effect of the bearing surface or reflects the limited combination of femoral and acetabular prostheses.” 1Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Hip, Knee & Shoulder Arthroplasty: 2018 Annual Report. Adelaide: AOA, 2018. Figure has been reproduced in exact and complete form. For a full copy of the AOA National Joint Replacement Registry report, see aoanjrr.sahmri.com/annual-reports-2018.
  14. 14. Summary • Oxidized zirconium addresses the limitations of ceramic coatings • Nearly 2 million joints sold in the past 20 years • Excellent clinical outcomes and low revision rates out to 12 years –No known major complications –No known unexpected failure mechanisms • Lower roughness than CoCr on retrieved components –Confirms lab studies –Indicates promise for longer term results

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