The Influence of Sterilization Method on Articular Surface Damage of Retrieved Cruciate-Retaining Tibial Inserts
Abstract
This observational study was designed to determine the importance of sterilization method and insert thickness as predictors of articular damage of cruciate-retaining polyethylene components used in total knee arthroplasty. Ninety-nine explanted tibial inserts were evaluated for surface damage. Severe damage modes were observed in 36 of 52 of γ-irradiated inserts but none of those sterilized by ethylene oxide. Articular damage significantly correlated to time in vivo but not to insert thickness. Inserts sterilized by ethylene oxide gas in gas-permeable packaging exhibited a significantly lower damage accumulation rate compared with inserts sterilized by γ radiation and stored in air or an inert environment. γ irradiation and storage in argon instead of air reduced the frequency of severe damage such as delamination but not the overall damage rate.
Keywords: knee, total knee arthroplasty, polyethylene, retrieval, sterilization method
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Funding for this project was provided by the Missouri Bone & Joint Research Foundation.
Each author certifies that his or her institution has approved or waived approval for the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research. No protected health information, as defined by HIPAA, was recorded for this study.
The Conflict of Interest statement associated with this article can be found at doi:10.1016/j.arth.2011.10.023.
PII: S0883-5403(11)00572-9
doi:10.1016/j.arth.2011.10.023
© 2012 Elsevier Inc. All rights reserved.
