Pre-clinical studies to validate the MITCH PCR Cup: a flexible and anatomically shaped acetabular component with novel bearing characteristics.

A previous clinical study was undertaken to evaluate the safety and efficacy of an anatomically shaped, flexible acetabular cup. Clinical results achieved were satisfactory, although some deficiencies in the model were identified. Design changes to the original model have been implemented to improve both initial stability and long term biological fixation. This was achieved through modifications made to both the anchoring mechanism and by the application of an appropriate backing surface layer promoting bone on-growth. In addition, changes to the articulation couple have also been introduced to improve implant durability and bearing performance, utilising a carbon fibre reinforced polyetheretherketone--alumina couple. Simulated loading, in both models, was performed using Finite Element Analysis. Mechanical and tribological tests were also performed to ensure the robustness of the new optimised design. Bio-compatibility of the articulation couple was demonstrated using an animal model. Implantation of the device has been extensively tested and re-validated in vitro to achieve a favourable polar contact between cup and femoral head and establish a reproducible operative technique. This preliminary work is undertaken prior to commencing a post market surveillance study of the CE marked implant.