Degradation of and intraosseous reactions to biodegradable poly-L-lactide screws: a study in minipigs.

In 20 minipigs an osteotomy of the lumbar spine was done at L3 and fixed with resorbable implants (plate and screws) made of poly-L-lactide. For 24 months postoperatively the cancellous bone surrounding the screws was examined histologically. Specimens from the body of lumbar spine L2 and L4, carrying the screws, were fixed in a series of ethanol immersions and then embedded in methylmethacrylate. Longitudinal and transverse sections were cut with a microtome at 4-5 microns and stained by the Masson-Goldner and Giemsa method for light microscopy. Our investigation confirmed a long degradation period of poly-L-lactide and little inflammatory reaction within the bone during the whole period of observation. For poly-L-lactide the degradation time exceeded the longest follow-up time in this study, 24 months. Polymorphonuclear granulocytes and mononuclear round cells were scarce in all follow-up groups. Osteolytic changes or the emergence of seroma was not observed. Textured bone was evident early close to a thin fibrous capsule surrounding the screws. The remodelling of the bone close to the screws ensues by the formation of osteons.