The biocompatibility of materials for internal fixation of fractures.

Surgically produced fractures of rabbit tibiae were internally stabilized with intramedullary rods of stainless steel (316LVM), titanium (6A1,4V), polyacetal (Delrin), and polyamide (Nylon 101). Periodic radiographs were taken until sacrifice at 16 weeks after fracture. Structural properties of the tibiae were determined in torsion with the rods in situ, and then the tissue was prepared for histology or microradiography. The results demonstrated that fracture remodeling was adversely affected by the metal rods. New bone was seen to have formed over the ends of the metal rods, and cortical bone resorption was observed in the fracture region, suggestive of transfer of mechanical stress to the rods, resulting in stress shielding of the diaphysis. Negligible osseous response to the polymeric rods was observed; fracture callus remodeling was extensive. The torsional test results demonstrated that fractures with polymeric rods were significantly stronger and tougher than those with metallic rods. With the exception of titanium, the strength of healed fractures was inversely related to the elastic moduli of the implant materials.