Background: Commonly, intramedullary nails are made of nondegradable materials, and hence they need to be removed once the bone fracture is healed. We propose a novel composite material consisting of poly-L-lactide matrix modified with carbon and alginate fibers to be used for biodegradable intramedullary fixation. The aim of this study was to make in vitro and in vivo biocompatibility assessments.
Methods: In the in vitro conditions, biocompatibility of biomaterials was compared using normal human osteoblasts. After 3 and 7 days, cytotoxicity, viability and proliferation tests were performed, as well as cell morphology and adhesion observations. In the in vivo experiments, Californian rabbits (approx. 9 months old) were used. The composite nails and controls (Kirschner wires) were used for fixation of distal femoral osteotomy. The evaluation was made on the basis of clinical observations, radiographs taken after 2, 4, 6 and 8 weeks post implantation, and macroscopic and histological observations.
Results: Cell tests indicated that both modifiers had a positive influence on cell viability. Biodegradable composite nails led to bony union when used for fixation of distal diaphysis osteotomy in rabbits. Histological analysis showed that the initial focal necrosis should be fully compensated for by the osteoblast proliferation and trabeculae formation.
Conclusions: Both in vitro and in vivo tests confirmed biocompatibility and potential applicability of novel biodegradable intramedullary nails modified with long carbon and alginate fibers for osteosynthesis of bone epiphysis.
Keywords: Alginate fibers; Carbon fibers; Composites; Intramedullary nails; Polylactide.