Bone regeneration with resorbable polymeric membranes: treatment of diaphyseal bone defects in the rabbit radius with poly(L-lactide) membrane. A pilot study.

Tubular poly(L-lactide) membranes with a pore size of 5-15 microns and a molecular weight of 70,000 Daltons were implanted into 24 New Zealand skeletally mature rabbits to cover 10-mm mid-diaphyseal defects of the radius of the forelimb. An identical defect on the contralateral limb was not treated with the membrane and served as a control. The animals were killed at 1, 2, 4, 8, 12, 24, 36, and 64 weeks after implantation, and radiographic and microscopic studies were conducted. The canals of the polymeric tubes were initially filled with blood. At 2 weeks, there was direct woven bone formation within the polymeric tube in continuity with the fragment cortices and its medullary canal. The formation of woven bone across the defect progressed until reconstruction of the defect had occurred at 6-8 weeks. The bone continued to remodel throughout the observation period of 64 weeks. By 12 weeks, bone within the lumen of the implant consisted of cancellous bone and cortical bone lining the membrane walls. At 24, 36, and 64 weeks, the implants were filled with cancellous bone and cortical bone in direct apposition to the polymer membrane. For one implant, the newly formed woven bone had only incompletely filled the defect at 8 weeks. This resulted in a nonunion with a residual gap of 0.5 mm and the appearance of mature bone. There was extensive bone formation along the intraosseous membrane in both control and implanted defects, although the untreated defects were rapidly filled with overlying muscle and soft tissues. The osseous activity of the untreated defects appeared confined to the bone ends by the interposed muscle and fibrous soft-tissue margins. The untreated defects resulted in radial-ulnar synostosis along the intraosseous membrane with cortical bone caps at the bone ends. The poly(L-lactide) membrane remained intact throughout the 64-week period without evidence of significant degradation. The membranes were encapsulated in a thin fibrous tissue. There was no histological evidence of acute or chronic inflammation associated with the implants.