Preclinical evaluation of the efficacy and safety of a new osteoplastic material of xenogenic origin containing vancomycin or meropenem

Abstract

Bone xenomatrix is an available material for plasty due to its availability and possible significant modification. The purpose was comparative evaluation of the efficacy and safety of xenogenic bone graft material impregnated with antibiotics, vancomycin or meropenem, in an experiment on a model of long bone defect healing in rabbits. Methods The study was performed on 28 male rabbits aged from 8 months to 1.2 years. All animals were modeled with a cavity defect of the right and left distal femoral metaphysis measuring 4 × 4 × 6 mm. Bone matrix blocks of the same size were implanted into the defect cavity. Animals of group 1 (n = 8, control) were implanted with a free “clean” bone block. Animals of group 2 (n = 10) with a bone block saturated with vancomycin. Animals of group 3 (n = 10) with a bone block impregnated with meropenem. To assess the effectiveness and safety of the material, clinical, radiological, pathomorphological, histological, and laboratory methods were used. Results X-ray signs of substitution of the studied materials in the defect in animals of group 1 were noted by 182 days, in group 2 – by 84 days, in group 3 – about 182 days. In each group, there was a complication, arthrosis of the knee joint (one animal in each group). According to the histological study, it was found that in groups 2 and 3, a complete elimination of xenomaterial in the middle part of the defect and its replacement with trabecular bone was noted by 182 days after implantation. The severity of irritating action of the materials in the animals of groups 2 and 3 did not exceed the control value. The laboratory blood tests in the animals of groups 2 and 3 also did not reveal significant differences with group 1. Conclusion The developed osteoplastic materials based on bovine bone xenomatrix, impregnated with vancomycin or meropenem, have acceptable safety and efficacy characteristics.