Vitamin E diffused highly cross-linked polyethylene in total hip arthroplasty at five years: a randomised controlled trial using radiostereometric analysis.

AIMS: The objective of this five-year prospective, blinded, randomised controlled trial (RCT) was to compare femoral head penetration into a vitamin E diffused highly cross-linked polyethylene (HXLPE) liner with penetration into a medium cross-linked polyethylene control liner using radiostereometric analysis. PATIENTS AND METHODS: Patients scheduled for total hip arthroplasty (THA) were randomised to receive either the study E1 (32 patients) or the control ArComXL polyethylene (35 patients). The median age (range) of the overall cohort was 66 years (40 to 76).
RESULTS: The five-year median (interquartile range) proximal femoral head penetration into the E1 was -0.05 mm (-0.13 to -0.02) and 0.07 mm (-0.03 to 0.16) for ArComXL. At three and five years, the penetration was significantly greater in the ArComXL group compared with the E1 group (p = 0.029 and p = 0.019, respectively). All patient-reported outcomes (PROs) improved significantly from the pre-operative interval compared with those at one year, and remained favourable at five years. There were no differences between the two groups at any interval.
CONCLUSION: The five-year results showed that E1 polyethylene does not wear more than the control, ArComXL. This is the longest-term RCT comparing the wear performance and clinical outcome of vitamin E diffused HXLPE with a previous generation of medium cross-linked polyethylene. Cite this article: Bone Joint J 2017;99-B:577-84. ©2017 The British Editorial Society of Bone & Joint Surgery.

RCT Entities:   Population Interventions Outcomes