Biocompatibility and mechanical properties of a totally absorbable composite material for orthopaedic fixation devices.

Bioabsorbable polymer/inorganic phosphate fiber composites are prone to rapid degradation due to water sensitivity of the interface between the degradable polymer and the degradable fiber. This article describes successful fabrication and laboratory evaluation of a candidate bioabsorbable composite implant material with mechanical properties similar to bone. The composite studied was poly(ortho ester) reinforced with randomly-oriented, crystalline microfibers of calcium-sodium-metaphosphate. The component materials showed no acute cytotoxicity as determined by tissue culture agar overlay. Treating the microfibers with a diamine-silane coupling agent improved mechanical properties and slowed degradation in saline, but strength still decreased 50% in 1 week. When the composite material was then coated with a layer of matrix polymer alone it retained 70% of its strength and 70% of its stiffness after 4 weeks exposure to 7.4 pH Tris-buffered saline at body temperature. The marked improvement with the coating can be attributed to the hydrophobicity of poly(ortho esters).