ABSTRACT
Response to foreign materials includes local tissue reaction, osteolysis, implant loosening, and migration to lymph nodes and organs. Bionate 80A human explants show minor wear and slight local tissue reaction, but we do not know the response at the spinal cord, nerve roots, lymph nodes, or distant organs. This study aims to figure out reactions against Bionate 80A when implanted at the spinal epidural space of 24 20-week-old New Zealand white rabbits. In one group of 12 rabbits, we implanted Bionate 80A on the spinal epidural space, and another group of 12 rabbits was used as the control group. We studied tissues, organs, and tissue damage markers on blood biochemistry, urine tests, and necropsy. The animals' clinical parameters and weight showed no statistically significant differences. At 3 months, the basophils increased slightly in the implant group, platelets decreased in all, and at 6 months, implanted animals showed slight eosinophilia, but none of these changes was statistically significant. External, organ, and spinal tissue examination showed neither toxic reaction, inflammatory changes, or noticeable differences between groups or survival periods. Under microscopic examination, the Bionate 80A particles induced a chronic granulomatous response always outside the dura mater, with giant multinucleated cells holding phagocytized particles and no particle migration to lymph nodes or organs. Thus, it was concluded that Bionate particles, when implanted in the rabbit lumbar epidural space, do not generate a significant reaction limited to the surrounding soft tissues with giant multinucleated cells. In addition, the particles did not cross the dura mater or migrate to lymph nodes or organs.
ABSTRACT
PURPOSE: To assess the biomechanical effects of intra-tendinous injections of PRGF on the healing Achilles tendon after repair in a sheep model. METHODS: Thirty sheep were randomly assigned into one of the six groups depending on the type of treatment received (PRGF or placebo) and survival time (2, 4 and 8 weeks). The Achilles tendon injury was repaired by suturing the tendinous edges employing a three-loop pulley pattern. A trans-articular external fixation system was then used for immobilization. The PRGF or placebo was administered on a weekly basis completing a maximum of three infiltrations. The force, section and tension values were compared between the operated and healthy Achilles tendons across all groups. RESULTS: The PRGF-treated tendons had higher force at 8 weeks compared with the placebo group (p = 0.007). Between 2 and 4 weeks, a significant increase in force in both the PRGF-treated tendon (p = 0.0027) and placebo group (p = 0.0095) occurred. No significant differences were found for section ratio between PRGF-treated tendons and the placebo group for any of the time periods evaluated. At 2 weeks, PRGF-treated tendons had higher tension ratio compared with placebo group tendons (p = 0.0143). Both PRGF and placebo treatments significantly improved the force (p < 0.001 and p = 0.0095, respectively) and tension (p = 0.009 and p = 0.0039, respectively) ratios at 8 weeks compared with 2 weeks. CONCLUSION: The application of PRGF increases Achilles tendon repair strength at 8 weeks compared with the use of placebo. The use of PRGF does not modify section and tension ratios compared with placebo at 8 weeks. The tension ratio progressively increases between 2 and 8 weeks compared with the placebo.
