Prospective clinical and joint simulator studies of a new total hip arthroplasty using alumina ceramic heads and cross-linked polyethylene cups.

We report the findings from independent prospective clinical and laboratory-based joint-simulator studies of the performance of ceramic femoral heads of 22.225 mm diameter in cross-linked polyethylene (XLP) acetabular cups. We found remarkable qualitative and quantitative agreement between the clinical and simulator results for the wear characteristics with time, and confirmed that ceramic femoral heads penetrate the XLP cups at only about half the rate of otherwise comparable metal heads. In the clinical study, 19 hips in 17 patients were followed for an average of 77 months. In the hip-joint simulator a similar prosthesis was tested for 7.3 million cycles. Both clinical and simulator results showed relatively high rates of penetration over the first 18 months or 1.5 million cycles, followed by a very much lower wear thereafter. Once an initial bedding-in of 0.2 mm to 0.4 mm had taken place the subsequent rates of penetration were very small. The initial clinical wear during bedding-in averaged 0.29 mm/year; subsequent progression was an order of magnitude lower at about 0.022 mm/year, lower than the 0.07 mm/year in metal-to-UHMWP Charnley LFAs. Our results show the excellent tribological features of alumina-ceramic-to-XLP implants, and also confirm the value of well-designed joint simulators for the evaluation of total joint replacements.