Femoral Head Penetration of Vitamin E-Infused Highly Cross-Linked Polyethylene Liners: A Randomized Radiostereometric Study of Seventy Hips Followed for Two Years.

BACKGROUND: Highly cross-linked polyethylene infused with vitamin E (E-poly) was developed to increase oxidative resistance without affecting mechanical properties. We evaluated this type of polyethylene in a randomized clinical study that used radiostereometric analysis. Our objective was to compare the early-term femoral head penetration of an E-poly liner with that of a heat-treated polyethylene liner, ArComXL. We hypothesized that the clinical outcome at two years following total hip arthroplasty would be unaffected by the choice of polyethylene.

METHODS: In this prospective study, sixty-one patients (seventy hips) with noninflammatory hip osteoarthritis and a median age of fifty-eight years were randomized to receive either an implant with an E-Poly or a heat-treated highly cross-linked polyethylene liner. The patients were followed for two years and evaluated at three time points (three months, one year, and two years).

RESULTS: The median proximal penetration in the E-poly group increased from 0.04 mm at three months to 0.06 mm at two years of follow-up. Corresponding values for the ArComXL group were 0.03 mm and 0.10 mm. In both groups, significantly increased penetration was observed between three months and two years (E-poly, p = 0.02; ArComXL, p < 0.001), but between one and two years, the increase was significant only in the control group (E-poly, p = 0.23; ArComXL, p = 0.002).

CONCLUSIONS: The femoral head penetration of E-poly was very low at two years. Whether the increase observed between three months and two years was caused by creep, deformation, wear, or a combination of these cannot be determined by our study. There were no significant differences observed in femoral head penetration rates between E-poly and ArComXL. Currently, the theoretical advantages of E-poly remain to be confirmed.