A self-reinforcing biodegradable implant made of poly(ɛ-caprolactone)/calcium phosphate ceramic composite for craniomaxillofacial fracture fixation.

PURPOSE: Biodegradable polymer fixators have been used widely in oral and maxillofacial surgery for fracture management. However, short-comings such as insufficient mechanical strength, inappropriate degradation time, lack of radiolucency, and foreign body reactions during bone remodeling remain.

MATERIAL AND METHODS: In this study, calcium phosphate ceramic (CPC, including tricalcium phosphate [TCP] and tetracalcium phosphate/dicalcium phosphate [TTCP/DCP]) and poly(ε-caprolactone) (PCL) were used to fabricate biodegradable orthopedic fixation devices.

RESULTS: Different weight ratios of CPC were added to PCL, and the results showed that the PCL/CPC composites had good radiopacity, mechanical properties, and biocompatibility. CPC was transformed into hydroxyapatite when the composites were immersed in simulated body fluid. The PCL/TTCP/DCP composite had a higher compressive strength relative to PCL/TCP after setting, and this self-reinforcing property contributed to the hydration of TTCP/DCP and formation of apatite crystals. Thus, PCL/TTCP/DCP screws were prepared for animal studies. No postoperative mortality or complications were noted 6 months postsurgery. Biodegradation of the PCL/TTCP/DCP screws and newly formed bony tissue around the degraded composites were shown on both micro-computed tomography and histology. No peri-implant bone resorption was noted.

CONCLUSION: The self-reinforcing PCL/TTCP/DCP composite can be used to fabricate biodegradable fixators for fracture management in craniomaxillofacial fracture fixation.