The Latest Lessons Learned from Retrieval Analyses of Ultra-High Molecular Weight Polyethylene, Metal-on-Metal, and Alternative Bearing Total Disc Replacements

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Knowledge regarding the in vivo performance and periprosthetic tissue response of cervical and lumbar total disc replacements (TDRs) continues to expand. This review addresses the following 4 main questions: (1) What are the latest lessons learned from using polyethylene in large joints and how are they relevant to current TDRs? (2) What are the latest lessons learned regarding adverse local tissue reactions from metal-on-metal cobalt-chrome bearings in large joints and how are they relevant to current TDRs? (3) What advancements have been made in understanding the in vivo performance of alternative biomaterials, such as stainless steel and polycarbonate urethane, for TDRs in the past 5 years? (4) How has retrieval analysis of all these various artificial disc bearing technologies advanced the state-of-the-art in preclinical testing of TDRs? The study of explanted artificial discs and their associated tissues can help inform bearing selection as well as the design of future generations of disc arthroplasty. Analyzing retrieved artificial discs is also essential for validating preclinical test methods.

Section snippets

Update on Polyethylene Used in Total Joint Replacements and Disc Replacement

In total hip and knee arthroplasty, the dominant bearing technology for the past 50 years continues to be a CoCr alloy femoral component articulating against a polyethylene acetabular or tibial component.1 Especially within the past 2 decades, the polyethylene used in hip and knee joint arthroplasty has undergone major changes in terms of formulation.5 By contrast, the changes to polyethylene formulation in the spine are comparatively subtle, mirroring the early evolution of sterilization

Adverse Local Tissue Reactions in CoCr Alloy MOM TDR

Until recently, CoCr alloy MOM hip bearings were considered to be a reasonable alternative to reduce long-term wear and short-term dislocation risk in hip arthroplasty, even though long-term exposure to metal ions has been a concern with MOM for many decades.27 However, there has been a recent increase in the reports in the hip literature of short-term revision due to metal hypersensitivity, osteolysis, and pseudotumor formation.28, 29 These adverse local tissue reactions to MOM, although

Update on Device and Tissue Response to Alternative Biomaterials Used in TDR

Although polyethylene and CoCr alloy have a well-established track record as orthopedic bearing materials that can be traced back over 5 decades, as noted in the previous section, many different polymers and metal alloys have been incorporated into modern TDRs, especially in the cervical spine. These “alternative biomaterials” have no long-term clinical history as bearing materials, and hence, retrieval analysis has the opportunity to provide especially crucial feedback regarding the

The Role of Retrieval Analysis in the Development of New TDR Test Methods

The aforementioned retrieval studies provide standardization bodies with scientific data by which in vitro test methods for TDRs can and should be validated. At present, few standards for TDR characterization exist.46, 47, 48 The standards that do exist are focused on static and dynamic characterization and intended bearing wear of the devices. Unlike other arthroplasty devices, test methods for the other modes of wear, including impingement and third-body wear, remain under development.

Summary and Conclusions

Our knowledge of TDR clinical performance based on explanted devices and tissues may no longer be in its infancy, but it still remains far from complete. The most retrieval data are available for historical TDRs in which polyethylene was effectively gamma irradiated in air. The wear and damage modes associated with these early devices conform to expectations of gamma-air-irradiated polyethylene from the literature. Contemporary TDRs incorporating conventional gamma-inert-sterilized

Disclosure

The research studies described in this article were supported in part by funding from NIH R01 AR47904, NIH R01 AR56264, and the FDA Critical Path Program. Institutional support for the Maverick, Prestige, and Bryan retrieval programs was received from Medtronic-funded IDE studies and Medtronic’s quality system. The institutions of one or more of the authors have received institutional funding from Medtronic, Stryker, Zimmer, Biomet, Depuy, Invibio, and Ticona. Dr. Toth is a scientifc consultant

Acknowledgments

The authors thank Genevieve Hill and Jonathan Peck, FDA, for their helpful discussions and collaboration on studying impingement in TDR, as well as Frank Chan, Megan Harper, Jacob Shorez, and Mark Dace, Medtronic, for their contributions. The authors gratefully acknowledge Amy Rizzo, MT(ASCP), for her extraordinary skill and technical expertise in producing histological sections of periprosthetic tissues.

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