Abstract
Introduction: Hip Simulator studies show that use of highly cross-linked polyethylene in total hip replacement reduces polyethylene (PE) wear by a factor of 85–98%. Early clinical studies using RSA or computer-aided techniques of polyethylene wear measurement show a reduction of 50–80%. There is speculation about why this discrepancy in the clinical and laboratory data should exist. The results of a randomized, prospective double blinded (surgeon and patient) trial (RCT) of cross-linked versus conventional polyethylene, using a 100% reproducible method of PE wear measurement, are reported.
Materials And Methods: After Ethics Committee approval, the two authors enrolled 124 patients onto an RCT comparing Enduron (non cross-linked PE) and highly cross-linked Marathon PE (DePuy, Leeds, UK). Randomization was performed by the circulating nurse intra-operatively opening an envelope which determined whether the patient received an Enduron or Marathon liner appropriate to the size of the metal shell. Liners were implanted into identical metal shells (Duraloc 300) with one screw. They articulated with identical 28mm CoCr femoral heads and cemented Charnley Elite femoral stems. All patients were followed with anteroposterior and lateral radiographs at 3 days, 6 weeks, 3 months 6 months, 1, 2, 3 and 4 years. PE wear was measured with PWAuto, a validated computer-assisted technique with 100% reproducibility and accuracy of ±0.13mm.
Results: One hundred and thirteen patients had appropriate radiographs and follow-up interval. Mean follow-up was 2.6 years (range 2–4 years). Fifty-eight patients received Enduron liners and 55 patients received Marathon liners. At 6 months (E=0.32, M=0.31mm) and one year (E=0.37, M=0.31mm) the three-dimensional PE wear was identical in both groups. Thereafter, all PE wear measurements showed a significant difference in PE wear between the two groups. Wear of the conventional Enduron group continued (0.51mm at 2 years, 0.70 at 3 years, 0.97 at 4 years), while the crosslinked Marathon group showed virtually no further wear (0.32mm at 2 years, 0.32mm at 3 years, 0.33mm at 4 years).
Conclusions: This is the first study to confirm that Hip Simulator predictions of cross-linked PE wear can be reproduced in-vivo. Randomization, double-blinding, and the use of a 100% reproducible technique for wear measurement add further weight to this data.
Correspondence should be addressed to Mr Peter Howard, Editorial Secretary, BHS, c/o BOA, The Royal College of Surgeons, 35–43 Lincoln’s Inn Fields, London WC2A 3PE, England.
