Preclinical trial of a novel surface architecture for improved primary fixation of cementless orthopaedic implants.

Abstract

A new surface architecture for cementless orthopaedic implants (OsteoAnchor), which incorporates a multitude of tiny anchor features for enhancing primary fixation, was tested in an ovine hemi-arthroplasty pilot study. Test animals were implanted with a hip stem component incorporating the OsteoAnchor surface architecture produced using additive layer manufacturing and control animals were implanted with stems containing a standard plasma sprayed titanium coating. Intra-operative surgeon feedback indicated that superior primary fixation was achieved for the OsteoAnchor stems and rapid return to normal gait and load bearing was observed post-operation. Following a 16-week recovery time, histological evaluation of the excised femurs revealed in-growth of healthy bone into the porous structure of the OsteoAnchor stems. Bone in-growth was not achieved for the plasma sprayed stems. These results indicate the potential for the OsteoAnchor surface architecture to enhance both the initial stability and long term lifetime of cementless orthopaedic implants.