研究单位：[1]Stryker Orthopaedics[2]Beijing Friendship Hospital[3]The First Affiliated Hospital of Jilin University,Chang chun, Jilin, China, 130000[4]Sir Run Run Shaw Hospital, Zhejiang University School of Medicine,Hangzhou, Zhejiang, China, 310000[5]Beijing Chao-Yang Hospital, Capital Medical University,Beijing, China, 100000[6]Xuanwu Hospital, Capital Medical,University,Beijing, China, 100000
This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).
This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period.
