Multicenter, randomized, single-blind, parallel-controlled non-inferiority assessment for safety and efficacy of rotator cuff injury and/or shoulder instability surgery
This clinical trial compares the clinical effects of rotator cuff injury and/or shoulder instability surgery with the full suture anchor made by Hangzhou Ruijian Mastine Medical Equipment Co., Ltd. and the polyether ether ketone bone anchor system made by Arthrex, Inc., USA, and evaluates the safety and effectiveness of the experimental device in clinical application
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
The equivalence of the two devices was compared by using control and experimental instruments during the operation
Full seam anchor
Hangzhou, Zhejiang, China
UCLA score
Efficiency of 6 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects \* 100%
Time frame: 6 months
UCLA score
Efficiency of 3 months after operation=Number of subjects with excellent score + good + acceptable score / total number of subjects \* 100%
Time frame: 3 months
constant-murley score
The higher the score, the better shoulder function.
Time frame: 3 months
ASES score
The higher the score, the better shoulder function.
Time frame: 3 months
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