Influence of copolymer composition of polylactide implants on cranial bone regeneration.

Biodegradable polymers have become useful auxiliary materials for the functional and structural restoration of bone deficiencies. Commercial implants from poly(L/DL-lactide) 70:30 are used clinically for fracture fixation in regions of low load. Implants manufactured from poly(L/DL-lactide) 80:20 are currently being investigated experimentally. The higher degree of crystallinity results in a higher chemical strength and loading capacity which promises advantages for long-term implantation. In this study implants from these two copolymers were applied to promote bone regeneration of bilateral, full thickness, circular cranial defects in 16 adult New Zealand white rabbits. The defects were covered with melt extruded and laser cut polylactide burr hole covers epicranially and endocranially in direct contact to the dura. The defect spaces were kept open with a spacer which created a hollow chamber. Both materials were implanted in each animal. Bone seeking fluorochromes were used to assess the pattern of bone growth. After eight weeks bone regeneration in the defects was assessed radiologically, histologically and by fluorescence microscopy. During the eight weeks observation period the application of a hollow chamber design resulted in almost complete cranial defect healing, whereby the copolymer composition had no effect on the amount or the morphology of the regenerate. The dura mater showed no adverse tissue reactions during these early stages of implantation. Eight weeks is only a short period in the lifetime of the tested polymers and complete bone regeneration can only be expected after complete polymer degradation. Long-term studies or accelerated degradation studies are required to confirm the expected advantages of poly(L/DL-lactide) 80:20.