Enhancement of biodegradation and osseointegration of poly(ε-caprolactone)/calcium phosphate ceramic composite screws for osteofixation using calcium sulfate.

Internal fixation devices, which can stabilize and realign fractured bone, are widely used in fracture management. In this paper, a biodegradable composite fixator, composed of poly(ε-caprolactone), calcium phosphate ceramic and calcium sulfate (PCL/CPC/CS), is developed. The composition of CS, which has a high dissolution rate, was expected to create a porous structure to improve osteofixation to the composite fixator. PCL, PCL/CPC, and PCL/CPC/CS samples were prepared and their physical properties were characterized in vitro. In vivo performance of the composite screws was verified in the distal femurs of rabbits. Results showed that the PCL/CPC/CS composite had a higher compressive strength (28.55 ± 3.32 MPa) in comparison with that of PCL (20.64 ± 1.81 MPa) (p < 0.05). A larger amount of apatite was formed on PCL/CPC/CS than on PCL/CPC, while no apatite was found on PCL after simulated body fluid immersion. In addition, PCL/CPC/CS composites also had a faster in vitro degradation rate (13.05 ± 3.42% in weight loss) relative to PCL (1.79 ± 0.23%) and PCL/CPC (4.32 ± 2.18%) (p < 0.001). In animal studies, PCL/CPC/CS screws showed a greater volume loss than that of PCL or PCL/CPC at 24 weeks post-implantation. Under micro-computerized tomography observation, animals with PCL/CPC/CS implants had better osseointegration in terms of the structural parameters of the distal metaphysis, including trabecular number, trabecular spacing, and connectivity density, than the PCL screw. This study reveals that the addition of CS accelerates the biodegradation and enhanced apatite formation of the PCL/CPC composite screw. This osteoconductive PCL/CPC/CS is a good candidate material for internal fixation devices.