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The availability of absorbable fracture-fixation devices for clinical use calls for better knowledge of the reaction of bone tissue to absorbable polyester implants as compared with similar metallic devices. To examine and compare the tissue response to biodegradable and metallic screws within cancellous bone, a transverse transcondylar osteotomy of the distal femur was fixed with absorbable self-reinforced polylevolactide screws in 35 rabbits and with stainless-steel screws in 35 rabbits. New bone formation and consolidation of the osteotomy were examined histologically, histomorphometrically, and microradiographically within standardized sample fields 1, 3, 6, 12, 24, 36, and 48 weeks postoperatively. The intact contralateral femur served as the control. A vigorous osteoconductive response to the polylevolactide screws was observed at 3 weeks postoperatively, and the osteoid surface fraction was significantly higher in all follow-ups than in the contralateral femora. In the femora with metallic screws, new bone formation was seen 3, 6, and 12 weeks postoperatively, but at 24, 36, and 48 weeks the osteoid surface fraction did not differ significantly from that of the intact control femora. The total bone area was significantly larger in the femora with self-reinforced polylevolactide screws than in the control bone 6-48 weeks postoperatively; in the femora with metallic screws, this was found only at 6 and 12 weeks. After 48 weeks, the femora fixed with metallic screws had statistically smaller total bone area than the intact control femora. Solid bone union was seen in 84% of the osteotomies in the self-reinforced polylevolactide group and in 76% of those in the metallic group after 3 weeks or more. No signs of degradation of the self-reinforced polyleuolactide implant and only a mild foreign-body reaction with no accumulations of inflammatory cells to either self-reinforced polylevolactide or metallic screws were observed during the follow-up period. Both types of screws seemed to induce an osteostimulatory response around their threads. This phenomenon was transient for metallic screws but lasted for at least 48 weeks for self-reinforced polylevolactide screws. The polylevolactide screw does not seem to cause osteopenia at the implantation site. The fixation properties of both self-reinforced polylevolactide screws and metallic screws appear to be sufficient for the fixation of small fragments of cancellous bone.

Self-reinforced polylevo-dextro-lactic acid (SR-PLA) 70 composite rods, (2 mm x 26 mm) were implanted in the dorsal subcutaneus tissue of sixteen rats. Osteotomies of the distal femur were fixed with SR-PLA70 composite rods (2 mm x 15 mm) in 39 rats. The follow-up times varied from 1 week to 1 year. After sacrifice three-point bending and shear tests were performed for subcutaneously placed rods, and radiological, histological, histomorphometrical, microradiographic, and oxytetracycline-fluorescence studies of osteotomized and intact control femora were performed. At 52 weeks the shear strength and flexural modulus of the rods were 41% of the initial value, and the flexural strength was 43% of the initial value. In the osteotomies seven specimens had to be excluded due to postoperative infection or dislocation of the fragment. Six of the thirty-two evaluated osteotomies showed signs of postoperative infection. Twenty-six osteotomies healed uneventfully. No signs of inflammatory or foreign-body reaction were observed. The present investigation demonstrated that the mechanical strength and fixation properties of the SR-PLA70 rods are suitable for fixation of cancellous bone osteotomies in rats. The present article is the first report on successful application of SR-PLA70 rods for fixation of cancellous bone osteotomies studied.

Osteotomies of distal femoral diaphysis were fixed intramedullary with self-reinforced poly-L-lactide acid (SR-PLLA) rods in 19 and with metallic rods in 34 adult rabbits. The follow-up times were 8, 16, 24, and 48 weeks. Plain radiographs, computed tomography (CT), quantitative computed tomography (QCT), and magnetic resonance imaging (MRI) were used to evaluate the bone changes at two different levels of the osteotomy region. There were no significant differences in cortical bone density compared to the intact in the SR-PLLA fixed femurs at the osteotomy site. In the metallic-fixed femurs, the density values were significantly lower as compared to the contralateral femurs. There was a significant reduction of the cortical bone density values in SR-PLLA fixed femurs compared to the intact control side outside the osteotomy area at 8 (p = 0.01), at 16 (p = 0.0001), and at 24 weeks (p = 0.0003). In the metallic-fixed femurs significant reductions at 8 weeks (p = 0.02), at 16 weeks (p = 0.01), at 24 weeks (p = 0.009), and at 48 weeks (p = 0.002) were found compared with the intact control. MRI depicted well the SR-PLLA cases allowing studies without removal of the implant. On the contrary, abundant disturbing metallic artifacts were detected during investigation of the metallic-fixed femurs. In conclusion, our results indicated that CT is useful to evaluate the quality of reduction and internal fixation. Furthermore, the constant presence of internal metallic fixation seems to eventually cause osteoporosis in the cortical region of the femur. However, this stress protection effect of intramedullary fixation on the femoral diaphysis seems to be avoided by using an absorbable SR-PLLA rod, thus resulting in a better quality of bone when the osteotomies are healed.