Degradation of poly-L/DL-lactide versus TCP composite pins: a three-year animal study.

Biodegradable polylactide implants allow secure fixation of osteochondral fractures. This quasirandomized parallel-group animal study investigates whether a composite implant of poly-L/DL-lactide (PLDLLA) with additional 10% beta-tricalcium phosphate produces an osteoconductive effect, whether the admixture positively influences implant degradation (assessed by comparing time to implant degradation), and whether the pin sites of degraded implants are replaced with bone tissue. On 36 medial femoral condyles of sheep, osteotomies were fixed with either three PLDLLA pins or three composite pins. At 3, 18, and 36 months, the pin sites were measured histologically and the state of degradation assessed according to Pistner's classification. All fractures healed without clinically relevant complications and without displacement. Both pin types led to asymptomatic pin-site enlargement at 18 months, which disappeared by 36 months. At 18 months, 14 of 18 PLDLLA pins were no longer evident, whereas 16 of 18 composite pins showed only peripheral degradation. By 36 months, all implants from both groups were completely degraded and replaced with scar (2/18) or bone tissue (16/18). At 36 months there was no evidence for significant improvement of either degradation performance or osseointegration through use of the 10% TCP composite mixture.

A comparative radiological assessment of polylactide pins over 3 years in vivo.

Biodegradable polylactide implants allow secure fixation of osteochondral fractures with minimal adverse effects. The goal of this prospective, randomized animal study was to show whether osteoconductive effects can be achieved through the development of poly-L/DL(70/30)lactide composite implants with 10% beta-tricalcium phosphate, and whether degradation can be positively influenced and adverse effects minimized using such implants. An additional goal was to clarify which radiological procedure is most suitable to observe the course of follow-up. Thirtysix medial femoral condyle osteotomies of sheep were fixed with either 3 poly-L/DL-lactide pins or 3 composite pins, and the pin canal widths were measured with conventional radiographs, with CT, MRI, and histologically after 3, 18, and 36 months. All fractures healed completely without displacement or clinically relevant complications. The pin canals dilated secondary to pin degradation at the 12th month, and then decreased in size later. At 36 months, the pins had microscopically disappeared, and the canals were filled with bone or scar tissue. There were no statistically significant differences between the pin-types. Poly-L/DL-lactide pins and composite C-pins are suitable for secure fixation of small osteochondral fractures. Osteoconductive effects of biocompatibility or osseous integration relating to composite development were not evident. Conventional radiography and computer tomography were suitable techniques for observation of pin canals. Due to frequently observed artifact, MRI was not suitable to observe the course of the implants.