Nearly 500,000 total knee and hip replacements are performed annually in the United States. The generation of ultra-high molecular weight polyethylene (PE) particulate wear debris and associated osteolysis has increasingly become the predominant cause of revision operation. Research has shown that radiation sterilization in air results in increased oxidative degradation and accelerated wear of PE components. The overall goal of this work was to better understand the effect of sterilization, radiation crosslinking, and aging on the oxidative degradation and wear performance of PE components in order to improve clinical outcomes in total joint replacement. The data indicated that after four years of real-time shelf aging, PE that was radiation sterilized in air or nitrogen had significantly greater oxidative degradation compared to PE that was sterilized with either gas plasma or ethylene oxide. After two years of real-time shelf aging, negligible oxidation occurred with minimal changes in density and percent crystallinity, indicating that oxidative degradation was not an issue in the highly crosslinked and conventional polyethylene components examined. The differences measured between time zero and two years shelf aging may be likely explained by instmmentation error or variation within polyethylene manufacturing lots. Data suggest that current manufacturing and packaging technologies have successfully avoided oxidative degradation during shelf aging. Shelf aging may not be a concern in highly crosslinked or conventional polyethylene with current packaging technologies.
Conventional PE tibial components had significantly greater percent area of premelt total surface damage compared to crosslinked PE tibial components. However, conventional PE tibial components did not have a significantly different percent area of postmelt total surface damage compared to crosslinked PE tibial components. Data indicated that in vivo duration was a significant predictor of premelt surface damage, accounting for 48 % of the variability, and postmelt surface damage, accounting for 37% of the variability. Linear regression determined that PE type was a significant predictor accounting for approximately 64% of the variability in the oxidation index. Neither shelf aging, in vivo duration, shelf age, ex vivo duration nor PE thickness were significant predictors of oxidation.