Abstract
Background
First-generation highly cross-linked polyethylene liners have reduced the incidence of wear particle-induced osteolysis. However, failed acetabular liners have shown evidence of surface cracking, mechanical failure, and oxidative damage. This has led to the development of second-generation highly cross-linked polyethylene, which has improved wear and mechanical properties and resistance to oxidation in vitro. Owing to its recent introduction, there are no publications describing its clinical performance.
Questions/purposes
We assessed early clinical wear of a second-generation highly cross-linked polyethylene liner and compared its clinical performance with the published results of hip simulator tests and with first-generation highly cross-linked polyethylene annealed liners.
Patients and Methods
Twenty-one patients were enrolled in a prospective cohort study. Clinical outcome and femoral head penetration were measured for 19 patients at 6 months and 1 and 2 years postoperatively.
Results
The median proximal head penetration was 0.009 mm and 0.024 mm at 1 and 2 years, respectively. The median two-dimensional (2-D) head penetration was 0.083 mm and 0.060 mm at 1 and 2 years, respectively. The median proximal wear rate between 1 and 2 years was 0.015 mm/year.
Conclusions
The wear rate calculated was similar to the in vitro wear rate reported for this material; however, it was less than the detection threshold for this technique. Although longer followup is required for wear to reach a clinically quantifiable level, this low level of wear is encouraging for the future clinical performance of this material.
Level of Evidence
Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
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Acknowledgments
The authors thank Meegan Bartell for her assistance with collection of patient data in this study, Yvonne Johnston for her skills with RSA imaging, and Alexandra Pearce for her assistance in preparing the manuscript.
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One or more of the authors (DGC) has received funding from Stryker Orthopaedics, Mahwah, NJ.
Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.
This work was performed at Wakefield Orthopaedic Clinic.
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Campbell, D.G., Field, J.R. & Callary, S.A. Second-generation Highly Cross-linked X3™ Polyethylene Wear: A Preliminary Radiostereometric Analysis Study. Clin Orthop Relat Res 468, 2704–2709 (2010). https://doi.org/10.1007/s11999-010-1259-y
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DOI: https://doi.org/10.1007/s11999-010-1259-y