开发一种基于PLDLA/β-TCP复合材料的新型生物降解前宫板和螺丝系统
Younghoon Kwon1, Mosharraf Hossain2, Minsu Lee1
1OSTEONIC Co., Ltd., Seoul, Republic of Korea.
Journal of biomedical materials research. Part B, Applied biomaterials
|September 5, 2023
概括
一个新的可生物降解的前椎板/螺丝 (ACPS) 系统显示出前椎间盘切除和融合 (ACDF) 固定的希望. 临床前研究表明,有效的子稳定性和机械完整性超过26周,支持其潜在的临床用途.
科学领域:
- 生物材料科学 生物材料科学
- 整形外科手术 整形外科手术
- 医疗设备工程 医疗设备工程
背景情况:
- 生物降解材料越来越多地被用于骨科植入物,以避免长期的并发症.
- 前椎间盘切除和融合 (ACDF) 需要强大的固定,以确保脊柱的稳定性和促进融合.
研究的目的:
- 评估一种基于复合材料的新型生物降解前宫板/螺丝 (ACPS) 系统用于ACDF固定的有效性和安全性.
- 在体外和体内评估ACPS系统的机械性能和降解特性.
主要方法:
- 使用β-三酸 (β-TCP) 和聚-l/d-乳酸合聚合物 (PLDLA) 的生物复合物制造了一种ACPS设备.
- 在体外降解试验中,遵循ISO 13781:2017协议26周.
- 一项临床前体内研究涉及将ACPS系统植入混血犬体内,以评估其在ACDF后对聚乙乙 (PEEK) 子稳定性的影响.
主要成果:
- 在26周的时间里,ACPS系统在板块的分子重量和曲强度以及螺丝的扭转和拉出强度上显著降低.
- 螺丝扭力收益强度和拉出强度最初在第2周增加,然后下降.
- 在26周的研究期间,在动物模型中没有观察到PEEK子脱落或脱.
结论:
- 可生物降解的ACPS系统表现出有希望的机械性能和稳定性,用于ACDF固定.
- 该系统在临床前模型中有效地防止了聚乙烯基子子移位.
- 需要进一步的临床试验来确认这种可生物降解的ACPS系统的安全性和有效性.
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