组织工程与重建外科杂志2018，Vol.14Issue(2)：61-66,6.
人工颈椎间盘假体体外功能试验方法及评价策略
Functional Testing and Evaluation Tactics of Artificial Cervical Disc Prosthesis In Vitro
摘要
Abstract
Artificial cervical disc replacement which retains the movement of adjacent vertebral segments, reduce the stress level of adjacent segments, is conducive to preventing the degeneration of adjacent segments. At present, the domestic application of artificial cervical disc prosthesis is mainly imported products, most of domestic similar products are in the process of R&D and production. The in vitro evaluation methods of prosthetic cervical intervertebral disc prosthesis in vitro was presented, including subsidence, creep, expulsion, subluxation testing, dynamic and static compression, shear testing, wear testing. Combined with the biomechanical data of human cervical spine, the clinical safety and effectiveness of the product was evaluated. Based on the open data of the FDA on artificial cervical disc prosthesis, the results of in vitro functional tests of 5 different designs of artificial cervical disc prosthesis were analyzed and compared. The acceptable criterion for the in vitro evaluation test of artificial disc prosthesis was discussed,which can provide a reference for the R&D of domestic products.关键词
人工颈椎间盘假体/体外评价/生物力学/磨损试验Key words
Artificial cervical disc prosthesis/In vitro evaluation/Biomechanics/Wear test分类
医药卫生引用本文复制引用
张家振,翟豹,闵玥,刘斌..人工颈椎间盘假体体外功能试验方法及评价策略[J].组织工程与重建外科杂志,2018,14(2):61-66,6.基金项目
国家重点研发计划(2017YFB1104105). （2017YFB1104105）
