Repair of calvarial defects in rats by prefabricated, degradable, long fibre composite implants.

Abstract

We report results from an initial small animal study designed to provide information on the biocompatibility of a novel biodegradable composite designed for craniomaxillofacial reconstruction. Rat calvarium was chosen as a clinically analogous model, which allowed comparison between experimental groups (PCL alone, PCL/phosphate glass, or PCL/bioglass implants) and control groups (empty defects or bone grafted defects). All animals recovered well from surgery and no clinical complications were observed. Histological assessment indicated a lack of inflammatory response. The amount of new bone formation at the dural aspect of the implant was statistically significantly higher in the PCL/phosphate glass group than the other experimental groups. This study confirms, in a clinically analogous model, the promise of the novel PCL/phosphate glass composite material. Work is planned toward manufacturing scale up and clinical trials.