Creep and Wear in Vitamin E-Infused Highly Cross-Linked Polyethylene Cups for Total Hip Arthroplasty: A Prospective Randomized Controlled Trial.

BACKGROUND

Aseptic loosening, the most common indication for revision surgery in total hip arthroplasty, can result from osteolysis caused by polyethylene (PE) wear particles. PE wear is increased by age-related oxidation of PE and free radicals emerging during irradiation cross-linking. Diffusion of vitamin E into PE stabilizes free radicals to maintain the biomechanical properties of PE. The purpose of this study was to determine whether vitamin E-infused highly cross-linked PE cups could reduce wear rates.

METHODS

We performed a prospective randomized controlled trial, in which 62 patients were allocated to 2 groups: a study group that received a vitamin E-infused highly cross-linked PE (HXLPE/VitE) cup and a control group that received an ultra-high molecular weight PE (UHMWPE) cup. Using radiostereometric analysis, we measured the penetration of the femoral head into the cup 7 days after surgery (baseline) and then again at 6 months and at 1, 2, and 3 years later.

RESULTS

Baseline variables did not differ significantly between the groups. At 1, 2, and 3 years after surgery, the HXLPE/VitE cup showed significantly less cumulative penetration (creep and wear) than the UHMWPE cup (p = 0.004, p < 0.0001, and p < 0.0001, respectively). The cumulative penetration after 3 years was 0.200 mm for the HXLPE/VitE cup versus 0.317 mm for the UHMWPE cup (p < 0.0001). From 1 to 3 years after surgery, after creep had stabilized and further penetration was mainly due to wear, the mean penetration increased only 0.04 mm in the HXLPE/VitE cup and 0.116 mm in the UHMWPE cup.

CONCLUSIONS

Our results confirm that wear rates over the first 3 years following surgery were lower in HXLPE/VitE cups than in UHMWPE cups. This suggests that HXLPE/VitE cups may prevent osteolysis, implant loosening, and eventually revision surgery. Long-term follow-up data continue to be collected to confirm these findings.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.