Primary stability of an anatomical cementless hip stem: a statistical analysis.

The primary stability that the surgeon can achieve during surgery is a determinant of the clinical success of cementless implants. Thus, estimating what level of primary stability can be obtained with a new design is an important aspect of pre-clinical evaluation. The primary stability of a cementless hip stem is not only affected by the implant design, but also by other factors such as the mechanical quality of the host bone, the presence of gaps around the bone-implant interface, the body weight of the patient, and the size of the implant. Even the most extensive experimental study can only explore a small sub-set of all possible combinations found in vivo. To overcome this limitation, we propose a combination of experimental and numerical methods. The primary stability of a cementless anatomical stem is assessed in vitro. A finite element model is developed to accurately replicate the same experiment. The model is then parameterised over the various factors that affect the primary stability, and used in a Monte Carlo scheme to assess the primary stability over a simulated population. In this study, the method was used to investigate the mechanical stability of an anatomical cementless stem over more than 1000 simulated cases. Twenty cases were found macroscopically unstable, due to a combination of unfavourable conditions. The rest of the Monte Carlo sample showed on average a peak micromotion under stair climbing loading of 206 +/- 159 microm. The proposed method can be used to evaluate new designs in conditions more representative of the variability in clinical practice.