Tissue-implant interface at an absorbable fracture fixation plug made of polylactide in cancellous bone of distal rabbit femur.

The tissue-implant interface at a self-reinforced poly-L-lactide (SR-PLLA) expansion plug implanted in distal rabbit femoral cancellous bone was studied histologically, histomorphometrically, and microradiographically in 35 rabbits during consolidation of a transverse transcondylar osteotomy fixed with the SR-PLLA expansion plug. The absorbable plug for internal fixation of fractures and osteotomies measured 4.5 mm in diameter and 30 mm in length and had an expandable distal locking blade system. The femoral specimens were harvested in groups of 5-10 rabbits after a follow-up time of 3, 6, 12, and 24 weeks. The intact contralateral femur served as a control. Vigorous osteogenic response to the implant was already observed at 3 weeks postoperatively, and the osteoid surface fraction at 24 weeks was still significantly higher than in the unoperated contralateral femur. Incomplete union of the osteotomy seemed to result in increased fibrous tissue formation at the tissue-implant boundary. No signs of degradation of the SR-PLLA was observed within the entire follow-up period. The number of inflammatory cells at the tissue-implant interface was low. Consequently, the short-term biocompatibility of the implant was deemed acceptable. Clinical application of the expansion plug is being planned.