Preclinical testing of femoral hip components: an experimental investigation with four prostheses.

Existing standards for the preclinical testing of femoral hip implants have been successful in the objective of guaranteeing the implant's fatigue strength. There is a need for an experimental test which could ensure prostheses were not susceptible to aseptic loosening. In this study we measure the relative movement between the prosthesis and the bone of four different cemented femoral component designs in in vitro tests. The aim is to determine if differences can be distinguished and whether the differences correlate with clinical performance. The four designs are the Charnley (DePuy International Ltd., UK), the Exeter (Stryker Osteonics Howmedica Corp., USA), the Lubinus SPII (Waldemar-Link GmbH, Germany), and the Miiller Curved (JRI Ltd, UK). Five tests were carried out for each femoral component type, giving a total of 20 tests, and their permanent relative displacement (termed migration) and recoverable (i.e., elastic) relative displacement (termed inducible displacement) monitored over one million loading cycles. Considerable variation occurred in the tests. Nonetheless, most femoral components migrated medially, posteriorly, and distally. Most also rotated into varus. Translations of the Charnley (64 microns) and Lubinus (67 microns) implants were less than the Müller (72 microns) and Exeter (94 microns) implants, but this difference is not statistically significant. Most of the femoral components had rapid early migration followed by slower steady-state migration. With regard to the steady state inducible displacements of the prostheses, those of the Charnley, Exeter, and Lubinus decreased or were stable with respect to time, whilst those of the Müller typically increased with respect to time. It is concluded that migration is not a suitable basis for in vitro comparison of prosthesis designs. However inducible displacement trends provide a clinically comparable performance ranking.