Evaluation of New Biphasic Calcium Phosphate Bone Substitute: Rabbit Femur Defect Model and Preliminary Clinical Results

Autogenous bone grafting, used to repair bone defects, is limited and the donor site can experience complications. Compared to autogenous bone graft, artificial bones have different porosity, which might make them suitable alternatives to bone grafts. Here, two porous biphasic calcium phosphate bone substitutes, namely Bicera™ and Triosite™, are used in an animal study and clinical practice to find a suitable porosity for implantation. Bicera™ and Triosite™ consist of 60 wt% hydroxyapatite and 40 wt% β-tricalcium phosphate, with the porosity of Bicera™ (82%) being higher than that of Triosite™ (70%). In the animal study, the implantation procedure was carried out on twenty-four female New Zealand rabbits. 12 weeks after implantation, the new bones were well infiltrated into the Bicera™ and Triosite™ bone grafts. In the clinical study, patients with comminuted fracture, fracture nonunion, or arthrodesis were included in the study of bone substitution with Bicera™. 27 patients underwent fracture fixation treatment. Bone healing of 22.22% (6/27) of patients happened within 3 months after the surgery, and that of 66.67% (18/27) of patients happened within 6 months. These results reveal that Bicera™ has good incorporation with host bone, and that new bone is able to grow within the porous structure, giving it high potential in the treatment of bone defects.