生物骨科材料与临床研究2025，Vol.22Issue(5)：92-96,5.DOI:10.3969/j.issn.1672-5972.2025.05.017
人工指关节假体技术审评思考
Technical review consideration for artificial finger joints
阿茹罕 1吴静 1金乐 1张家振1
作者信息
- 1. 国家药品监督管理局医疗器械技术审评中心,北京,100076
- 折叠
摘要
Abstract
Finger joint replacement involves replacing damaged joints with artificial ones to treat joint injuries and alleviate pain,as well as improve hand deformities and stiffness.Such injuries are typically caused by rheumatic immune diseases,intra-articular infections,trauma,tumours and so on.Compared with large joints such as the hip and knee,the joints of the hand have the characteristics of small volume,complex and less covered soft tissue structure around the joints,and high requirements for joint range of motion.Therefore,finger joint prosthesis design and development differ considerably from that of large joint products.This article summarizes the structural forms of marketed products and previous review experiences,combining this with clinical application experience and issues with related products.It puts forward suggestions on the contents of review data,performance studies,animal tests and clinical evaluation research data for related products,aiming to provide references for the technical review of these products.关键词
人工指关节假体/指关节置换术/指关节活动度/关节磨损/医疗器械注册Key words
Artificial finger joints/Finger joint replacement/Finger joint mobility/Wear of joints/Medical device registration分类
医药卫生引用本文复制引用
阿茹罕,吴静,金乐,张家振..人工指关节假体技术审评思考[J].生物骨科材料与临床研究,2025,22(5):92-96,5.
