EVALUATION OF THE USE OF CALCIUM SULFATE HA/TCP COMPOSITES IN A CANINE METAPHYSEAL DEFECT MODEL: LONG TERM FOLLOW-UP

Abstract

The purpose of this study was to evaluate trabecular bone response, at fifty-two week follow-up, to four different synthetic graft materials (CaSO4 and CaSO4 – HA/TCP composites) as compared to autograft in a canine defect model. The group with the highest HA/ TCP proportion had the greatest amount of residual graft material and total mineralized material. Increasing the proportion of HA/TCP reduces the rate of dissolution, and appears to have little effect on bone formation at long term follow-up. This study further suggests that a range of composites could be created to match the spectrum of resorption rates demanded by clinical applications.

The purpose of this study was to evaluate trabecular bone response to four synthetic graft materials (CaSO4 and CaSO4 – HA/TCP composites) as compared to autograft in a canine defect model, at long term follow-up.

Both 85% CaSO4 – 15% HA/TCP and 65% CaSO4 – 15% HA/TCP showed bone formation similar to autograft. The group with the highest proportion of HA/TCP lasted longer than the other formulations. The results suggest that increased HA/TCP proportions reduce the rates of dissolution, without compromising bone formation in the current model.

Results suggests that a range of composites could be created to match the spectrum of resorption rates demanded by clinical applications.

In this REB-approved RCT, bilateral humeral and femoral cylindrical defects were filled with one of four types of pellets with varying proportions of CaSO4 – HA/TCP, autograft bone, or left unfilled. After sacrifice at six, twelve, twenty-six or fifty-two weeks, defect sites were evaluated histologically for tissue and inflammatory response, area fractions of residual graft material, and bone ingrowth in the defects.

The area of the defect occupied by residual graft material in the group with the highest percentage of HA/TCP was greater than in other composite groups (p< 0.0001). This group contained the greatest amount of total mineralized material (graft material + bone) (p< 0.03. The extent of new bone formation increased from twelve to twenty-six weeks (p< 0.0001). Both 85% CaSO4 – 15% HA/TCP and 65% CaSO4 – 15% HA/TCP showed bone formation similar to autograft.

Funding: Research grant from Stryker Howmedica, Matwah, NJ.