Okay Erhan, Ozarslan Ali Can, Başal Özgür, Cakıroglu Hüseyin, Yucel Sevil, Özkan Korhan, Doral Mahmut Nedim
Department of Orthopaedics, Goztepe Research and Training Hospital, Istanbul, TUR.
Faculty of Chemical and Metallurgical Engineering, Department of Bioengineering, Yildiz Technical University, Istanbul, TUR.
Cureus. 2023 Jul 7;15(7):e41521. doi: 10.7759/cureus.41521. eCollection 2023 Jul.
Background Bone is a dramatically regenerating tissue with the ability to heal after trauma, although intensive surgical management is required to treat considerable damage. In this study, 45S5 bioactive grafts were prepared through the melt-quenched method in compliance with the guidelines on medical product requirements (MDD regulations; 93/42/EEC Annex-II section 3&4 and ISO standardizations; ISO 13485:2016) for bone repair and regeneration. Methodology After preparing the graft/scaffold, it was evaluated for biocompatibility according to the principles of "lSO 10993-6 2015 Biological evaluation of medical devices: Tests for local effects after implantation, Annex D 'Test method for implantation in bone,'" "lSO 10993-2:2005 Biological evaluation of medical devices: Animal welfare requirements," and "lSO 10993-12 2012 Biological evaluation of medical devices sample preparation rules and standards." Defects were created on the tibia of the right hind leg. The defects were filled with 3-mm bioactive granules, and a cylindrical polypropylene biocompatible material was used as a negative control. After 120 days, the sheep were sacrificed, and the tibia were analyzed. Results The results demonstrated the safety of 45S5 bioactive grafts. Histological evaluation showed no signs of pathological changes around the implant area. Hematoxylin and eosin sections demonstrated the presence of a few multinucleated giant cells, macrophages, and non-irritant mild fibrotic changes on the surface of the biomaterial. Conclusions 45S5 bioactive glass was found to be biocompatible in a sheep model, demonstrating its capacity to promote bone consolidation while also justifying its further preclinical application as a bone-bonded material owing to the layer formation of the growing bone mineral.
背景 骨骼是一种具有显著再生能力的组织，能够在创伤后愈合，尽管治疗严重损伤需要强化手术管理。在本研究中，按照医疗器械要求指南（医疗器械指令法规；93/42/EEC附件II第3和4节以及ISO标准化；ISO 13485:2016），通过熔融淬火法制备了45S5生物活性移植物用于骨修复和再生。
方法 在制备移植物/支架后，根据“ISO 10993-6 2015医疗器械生物学评价：植入后局部效应试验，附件D‘骨内植入试验方法’”、“ISO 10993-2:2005医疗器械生物学评价：动物福利要求”以及“ISO 10993-12 2012医疗器械生物学评价样品制备规则和标准”的原则对其生物相容性进行评估。在右后腿胫骨上制造缺损。用3毫米生物活性颗粒填充缺损，并使用圆柱形聚丙烯生物相容性材料作为阴性对照。120天后，处死绵羊并分析胫骨。
结果 结果证明了45S5生物活性移植物的安全性。组织学评估显示植入区域周围没有病理变化的迹象。苏木精和伊红切片显示生物材料表面存在一些多核巨细胞、巨噬细胞以及无刺激性的轻度纤维化变化。
结论 发现45S5生物活性玻璃在绵羊模型中具有生物相容性，表明其具有促进骨愈合的能力，同时由于生长骨矿物质的层状形成，也证明了其作为骨结合材料进一步进行临床前应用的合理性。
