The Pros and Cons of Polyethylene Sterilization with Gamma Irradiation

Abstract

This retrospective study evaluated the implant, patient and surgical factors associated with polyethylene wear for one type of porous-coated hemispheric total hip arthroplasty cup. Radiographic wear measurements among 567 Duraloc cups (512 patients) revealed that liners sterilized by gamma-irradiation wore 0.085 mm/year less than those that were sterilized by gas-plasma, a noncross-linking chemical surface treatment. The substantially decreased wear rate associated with gamma-irradiation was attributed to sterilization-induced polyethylene cross-linking. Shelf-aging adversely affected liners that were gamma irradiated in air. On average, highly crystalline Hylamer liners showed a 0.064 mm/year increase in wear rates for each year of shelf storage after terminal sterilization with gamma-irradiation in air. Among conventional Enduron liners, the effect of shelf aging after gamma-irradiation in air was more modest, increasing wear rates by 0.014 mm/year for each year of shelf storage. Because Hylamer's wear performance degraded at about five times the rate of Enduron's, the improved wear resistance associated with gamma-irradiation in air would be lost after 1.3 years of shelf aging for Hylamer compared with 6.1 years for Enduron. For every additional year of age at the time of surgery, the wear rate decreased by 0.003 mm/year. Increased body mass index, a preoperative diagnosis of inflammatory arthritis, and a ceramic femoral head also were associated with decreased wear rates.