Wear rate of highly cross-linked polyethylene in total hip arthroplasty. A randomized controlled trial.

BACKGROUND: Highly cross-linked polyethylene was introduced for clinical use in total hip arthroplasty with the expectation that it would exhibit less wear when compared with conventional polyethylene. The purpose of this study was to report the clinical and radiographic results, after a minimum of five years of follow-up, of a randomized, blinded, controlled trial comparing a conventional polyethylene with a first-generation highly cross-linked polyethylene.
METHODS: One hundred patients were enrolled in a prospective, randomized controlled study comparing highly cross-linked and conventional polyethylene acetabular liners in total hip arthroplasty. Fifty patients were in each group. At the time of follow-up, clinical outcomes were assessed and steady-state femoral head penetration rates (after bedding-in) for each patient were calculated with use of a validated radiographic technique. In addition, a statistical comparison of polyethylene wear between groups was performed with use of generalized estimating equations.
RESULTS: At a mean of 6.8 years postoperatively, there were no differences between the two polyethylene groups with regard to the Harris hip score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), or Short Form-12 (SF-12) score. The mean femoral head penetration rate in the first through fifth years was found to be significantly lower in the group treated with the highly cross-linked polyethylene (0.003 mm/yr [95% confidence interval, +/-0.027]) than it was in the group treated with conventional polyethylene (0.051 mm/yr [95% confidence interval, +/-0.022]) (p=0.006). Men treated with a conventional polyethylene liner had a significantly higher (p<or=0.012) femoral head penetration rate (0.081 mm/yr [95% confidence interval, +/-0.065]) than both men and women with a highly cross-linked liner (-0.013 mm/yr [95% confidence interval, +/-0.074] and 0.009 mm/yr [95% confidence interval, +/-0.028], respectively). The general estimating equations demonstrated that the group with a highly cross-linked polyethylene liner had a significantly lower femoral head penetration rate than the group with a conventional polyethylene liner (p=0.025), and a significantly higher femoral head penetration rate was demonstrated in men with a conventional polyethylene liner when compared with both men and women with a highly cross-linked liner (p=0.003).
CONCLUSIONS: At a minimum of five years postoperatively, the steady-state femoral head penetration rate associated with this first-generation highly cross-linked polyethylene liner was significantly lower than that associated with a conventional polyethylene liner. Long-term follow-up is required to demonstrate the clinical benefit of this new material.

RCT Entities:   Population Interventions Outcomes