Introduction and Aims: The usefulness of bone graft substitutes and growth factors to promote bone graft incorporation and prosthesis fixation in hip replacement should be examined in a loaded model, as results from cortical defect models may not apply. This paper reviews the results of femoral impaction grafting using these materials in an ovine hip replacement model.
Method: At cemented hemiarthroplasty, sheep femurs were impacted with allograft bone (control group n=23) or with allograft mixed with: 1) corglaes bioglass (n=12); 2) a synthetic hydroxyapatite (HA) (n=6) or the bone morpohogenetic protein OP-1 (n=6) (study groups) and implanted with a cemented double taper femoral stem. Sheep were sacrificed at between six and 26 weeks. The primary outcome was femoral stem subsidence, as determined more recently by the development of clinical radiostereometric analysis (RSA) in this model. Femoral fixation, as assessed by ex-vivo mechanical testing, and bone graft incorporation, as assessed by histological review and histoquantitation, were also key outcomes.
Results: In the control groups, there was a consistent response with bone graft incorporation by new bone advancing proximal to distally in the femur and advancing from the endocortex towards the cement mantle. Mineralised bone apposition occurred by six weeks and this was preceeded by partial resorption of the graft. Complete graft incorporation, with subsequent remodelling of bone, was evident proximally by 26 weeks. Bone graft incorporation in femurs impacted with a 1:1 allograft: bioglass mix was minimal and there was often partial or complete resorption of the graft with replacement by fibrous tissue, resorption of endocortical bone and instability of the femoral prosthesis. Supplementation of allograft with OP-1 promotes initial graft resorption, thus hastening bone graft incorporation and remodelling but one case of stem subsidence, that may have been associated with early resorption seen in the OP-1 group, reinforces the need for further studies examining dose response. There was excellent incorporation of the allograft and HA, with new woven bone directly apposing the HA surface and integrated into the larger porous spaces of the HA. There was no adverse response to the HA and there was minimal to no subsidence of the stem at the cement-bone interface, as determined by RSA.
Conclusion: This model is extremely valuable for investigating new biological approaches to reconstruction of major bone deficiency at revision hip replacement and demonstrates clear differences between materials used to supplement allograft, with HA and OP-1 giving encouraging results. RSA is an essential outcomes tool for this model.