Osteoconductive composite grouts for orthopedic use.

A composite of HA particulate and calcium sulfate hemihydrate has been developed. When this dry material is mixed with either sterile saline or water, the resulting mixture begins to gel. While in the gel or dough state, the composite can be manually inserted or injected under pressure into a bone defect where it sets in situ. The calcium sulfate acts as a binder to hold the HA particles in place. The subsequent resorption of the calcium sulfate leaves controlled porosity for bone ingrowth and attachment to the nonresorbable HA particulate. The combination of calcium sulfate and HA results in a composite with handling properties superior to those of HA alone. Calcium sulfate has a long history of medical use as an implant material. The biocompatibility of the material has been clearly established. The combination of HA and calcium sulfate is likewise extremely compatible as demonstrated in the present studies. Bone ingrowth concomitant with resorption occurs rapidly with efficient conduction of bone from particle to particle. Based on the experiments presented herein, the composite of HA and calcium sulfate may be a useful alternative or adjunct to autogenous bone grafting. Many questions, however, remain regarding long-term tissue response and bone remodeling as well as the efficacy of this material relative to bone grafting.