Vanaclocha-Saiz Amparo, Vanaclocha Vicente, Atienza Carlos, Jorda-Gomez Pablo, Primo-Capella Víctor, Barrios Carlos, Vanaclocha Leyre
Instituto de Biomecánica (IBV), Universitat Politècnica de Valencia, Valencia 46022, Spain.
University of Valencia, Valencia 46015, Spain.
ACS Omega. 2022 Aug 19;7(34):29647-29654. doi: 10.1021/acsomega.2c01690. eCollection 2022 Aug 30.
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 , 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 or migrate to lymph nodes or organs.
对外来材料的反应包括局部组织反应、骨质溶解、植入物松动以及向淋巴结和器官的迁移。Bionate 80A人体植入物显示出轻微磨损和轻微局部组织反应，但我们不知道其在脊髓、神经根、淋巴结或远处器官的反应情况。本研究旨在弄清楚将Bionate 80A植入24只20周龄新西兰白兔的脊髓硬膜外间隙时的反应。在一组12只兔子中，我们将Bionate 80A植入脊髓硬膜外间隙，另一组12只兔子作为对照组。我们研究了血液生化、尿液检测和尸检中的组织、器官以及组织损伤标志物。动物的临床参数和体重没有统计学上的显著差异。3个月时，植入组嗜碱性粒细胞略有增加，所有组血小板均减少，6个月时，植入动物出现轻微嗜酸性粒细胞增多，但这些变化均无统计学意义。外部、器官和脊髓组织检查未发现毒性反应、炎症变化，组间或生存期之间也无明显差异。在显微镜检查下，Bionate 80A颗粒总是在[此处原文缺失相关结构名称]外引发慢性肉芽肿反应，有巨大的多核细胞吞噬颗粒，且无颗粒迁移至淋巴结或器官。因此，得出结论：当Bionate颗粒植入兔腰椎硬膜外间隙时，不会产生仅限于周围软组织的显著反应，伴有巨大的多核细胞。此外，颗粒未穿过[此处原文缺失相关结构名称]或迁移至淋巴结或器官。
