A new generation of experimental pre-clinical testing methods for cemented hip replacement femoral components have been proposed, and preliminarily validated by comparing a ‘good’ prosthesis design with a ‘bad’ prosthesis design. The basis for these new tests is the measurement of relative motion between im plant and bone over time while loading is applied. However, it is yet to be proven whether these next generation tests can satisfactorily distinguish between the performance of several prosthesis designs. Additionally, opinions vary widely as to the necessary loading conditions required, particularly over whether or not muscle loading should be simulated.
A novel experimental rig which mimicked physiological loading of the implanted proximal femur was developed. Using this rig, the influence of simulated muscle loading on the migration of a femoral component was investigated. Numerical simulations were performed to ascertain possible reasons for differences between migration patterns. Experimental tests consisting of one million loading cycles with muscle loading were performed using four different prosthesis designs; the Charnley Extra Small, the Exeter Polished, the Lubinus SPII, and the Miiller Curved.
Muscle loading was found to reduce the migration of the femoral component within the medullary canal of the femur. Differences in migration and inducible displacement (recoverable cyclic motion) were detected between the four prosthesis designs, although not at a significant level. A performance ranking of the designs based on migration did not agree with observed clinical performance as measured by revision rate. However, ranking the prostheses based on whether their inducible displacements were increasing or decreasing did correlate with their clinical revision rates.
In conclusion, the experimental test can distinguish between the performance of several prosthesis designs. However, the sample size required to achieve statistical significance is prohibitive. Muscle loading should be included in experimental tests.