Crosslinked polyethylene compared to conventional polyethylene in total hip replacement: pre-clinical evaluation, in-vitro testing and prospective clinical follow-up study.

BACKGROUND: Polyethylene wear-induced osteolysis is a major cause of implant loosening in total hip arthroplasty. New crosslinked polyethylenes are presumed to give lower wear rates, but no long-term clinical results are available yet. PATIENTS AND METHODS: We compared basic material characteristics and MTS hip joint simulator wear rates of a crosslinked polyethylene (Duration) to those of conventional polyethylene. In a randomized double-blind 5-year clinical follow-up study, 133 hips (67 conventional, 66 Duration) in 127 patients were followed-up for an average of 5 (3-6) years. Wear rates were measured using a computer-based edge detection method. The radiographic appearances of wear-related phenomena were recorded.
RESULTS: The Duration polyethylene showed a significantly lower in-vitro wear rate in the simulator study (mean 22 (SD 2.3) vs. 40 (SD 1.5) mm3/106 cycles). Also, the in-vivo wear was lower for Duration (mean 0.083 (SD 0.056) mm/year) than for conventional polyethylene (mean 0.123 (SD 0.082) mm/year). All radiographic signs of osteolysis were less frequent in the Duration group.
INTERPRETATION: Our study has given a substantial body of evidence--from lower wear rates, less frequent signs of osteolysis, and higher survival rates after a mean follow-up of 5 years--that Duration provides better clinical outcomes than conventional polyethylene.

RCT Entities:   Population Interventions Outcomes