[Short-term safety and effectiveness of domestic polyether-ether-ketone suture anchors for rotator cuff repair: A multicenter, randomized, single-blind, parallel-controlled noninferiority study].

Objective: A multicenter, randomized, single-blind, parallel-controlled noninferiority study was used to evaluate the short-term safety and effectiveness of domestic polyether-ether-ketone (PEEK) suture anchor for rotator cuff repair by comparing with the imported PEEK suture anchor commonly used in clinical practice. Methods: A total of 59 patients with rotator cuff tears who were admitted between May 2019 and October 2019 were selected as the research objects. Among them, 3 patients were excluded because they did not meet the selection criteria, and 1 patient withdrew from the study because of serious adverse events. A total of 55 patients were included in the study. They were randomly divided into trial group ( Results: The operations in both groups were successfully completed, and there was no complication related to the operation and suture anchor. All incisions healed by first intention. There was no significant difference in follow-up time between trial group [(5.85±0.77) months] and control group [(5.96±0.72) months] ( Conclusion: The short-term safety and effectiveness of domestic PEEK suture anchors in rotator cuff tear repair are not significant different from those of imported PEEK suture anchors commonly used in clinical practice.