New polyethylenes in total hip replacement: a prospective, comparative clinical study of two types of liner.

Ultra-high-molecular-weight polyethylene sterilised in the absence of air and highly cross-linked polyethylene have been used to avoid osteolysis and loosening in total hip replacement. Our prospective randomised study has assessed the results using two different polyethylenes associated with the same prosthetic design. We assessed 45 Allofit acetabular components with a Sulene-polyethylene liner of conventional polyethylene gamma sterilised with nitrogen and 45 Allofit acetabular components with a Durasul-polyethylene liner sterilised in ethylene oxide, both matched with an Alloclassic stem with a 28 mm modular femoral head. The prostheses were implanted between May 1999 and December 2001. The mean follow-up was for 66.3 months (60 to 92). The linear penetration of the femoral head was estimated at 6 weeks, at 6 and 12 months and annually thereafter from standardised digitised radiographs using image-analysis software. There was no loosening of any prosthetic component. There were no radiolucent lines or osteolysis. The mean rate of penetration calculated from regression analysis during the first five years was 38 microm/year (SD 2) for the Sulene group and 6 microm/year (SD 1) for the Durasul group (p = 0.00002). The rate of penetration of the Durasul group was 15.7% of that of the Sulene group.

RCT Entities:   Population Interventions Outcomes