[Tibial malalignment of mobile-bearing prostheses--a simulator study].

Total knee replacement requires exact implantation in order to avoid long-term failure. Longitudinal in vivo studies of malaligned prostheses are problematic for ethical reasons. To assess the critical angle of tibial (varus/valgus) malalignment of knee prostheses in vitro, a simulator investigation was performed. Mobile-bearing prostheses were implanted in a simulator with 1-3 degrees valgus and varus malalignment as well as in a neutral position. More extreme malalignment caused unacceptable forces in the simulator. After each 500,000 cycles (ca. 0.5 years of walking) the replicas of the polyethylene inlay were examined and the extent of the tribocontact areas was measured until 1,500,000 total cycles. Finally the original polyethylene was examined with a scanning electron microscope. The polyethylene showed only abrasive wear without any fatigue effect. Tribocontact areas of 900-1500 mm(2) were observed under malalignment of mobile-bearing prostheses according to the manufacturer's specifications. With 1-3 degrees of malalignment, tribocontact areas were located at atypical polyethylene zones, but still showed abrasive wear only. Increasing malalignment due to a lift off of the femoral part of the prostheses with a strong torsional strength of the polyethylene made more extreme simulation impossible. Malalignment of 3 degrees could be suggested as maximum in vivo tolerability; perfect alignment with ideal implantation should be the goal. Soft tissue was given less consideration in this simulator study.