Introduction Bone graft supply for impaction grafting can be problematic due to the supply of graft, sterilisation, which alters the biological properties of the graft, and the immunogencity of the graft which may lead to graft rejection. Reducing the amount of graft can be accomplished by using increased amounts of synthetic materials such as hydroxyapatite (HA). This study evaluated the effect of using mixtures of porous HA (Apapore™) with allograft for cemented impaction allografting of the femoral stem in an ovine model. The aim was to test the hypothesis that increased quantities of Apapore™ will be stable and induce similar bone remodelling to that where a 50:50 mixture with allograft was used.

Method Twelve hemi-arthroplasty femoral components were inserted into the right hip of skeletally mature female commercially cross-bred sheep weighing between 65 and 80kg. Femoral components were manufactured from Cobalt Chromium alloy and cemented in place following impaction of the femoral canal. Animals were randomly placed into one of two groups according to the allograft-apapore mixture used. Group 1: Apapore:allograft mixed 50:50. Group 2: Apapore: allograft mixed 90:10. Six animals were investigated in each group. Implants remained in vivo for 6 months. In order to quantify bone formation rates, oxytetracycline injections were given 2 months post-surgery and 3 weeks later, followed by a third administration in the fifth month post-surgery and 3 weeks later. Animals were walked over a force plate pre-operatively and at 8, 16 and 24 weeks post-operatively. Twelve readings of maximum force (Fmax, N/m2) were taken and average values of right over left were calculated as a percentage (%AR/AL) and represented how well the animal used its operated leg where 100% represents full weight-bearing. Thin sections (~70μm thick) were prepared through four regions of the femur. The proximal, mid and tip of the femoral component region and one distal to the implant tip were analysed where bone area, Apapore™ area, Apapore™-bone contact and cement mantle thickness were quantified and compared using image analysis techniques.

Results In both groups, the use of graft resulted in the formation of a cancellous network of bone on the endosteal surface which incorporated the Apapore™ granules. When all regions were compared, femoral bone turnover results demonstrated significantly increased rates in group 1 (0.0021mm day-1) when compared with group 2 (0.0015mm day-1) (p< 0.05). No significant differences were identified when the proximal, mid and tip regions in the two groups were compared however, significantly increased turnover was identified in the distal region in group 1 (0.0027 mm day-1) when compared with group 2 (0.0013mm day-1) (p< 0.05). In both groups increased turnover was observed in the proximal, tip and distal regions with least in the mid region of the stem. Ground Reaction Force (GRF) results demonstrated no significant differences between the two experimental groups at 8, 16 and 24 weeks postoperatively. In both groups, a significant decline in function was demonstrated 8 weeks post-op when compared with pre-operative values and in both groups function gradually increased over time. Results for new bone area demonstrated significantly increased new bone in the proximal and distal regions in both groups (proximal =7.94mm2 and 7.13mm2; distal =7.03mm2 and 8.17mm2, group 1 and 2 respectively) with least new bone in the mid region of the stem (4.53mm2 and 4.79mm2). No significant differences in any of the regions were demonstrated when group 1 and 2 were compared. In both groups, significantly increased amounts of Apapore™ was observed in the proximal and distal regions of the femoral stem with least in the mid and tip region. No significant difference in cement mantle thickness was identified between the two groups.

Discussion Results demonstrated that hips maintained functional stability when a higher amount of Apapore™ mixture was used. Results for bone turnover rates and the amount of new bone formation in the 90:10 mixture demonstrated Apapore™ to be a comparable and suitable alternative to replace allograft in impaction grafting of a femoral component.