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

Abstract

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. 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 ( n=27) and control group ( n=28). The trial group used PEEK suture anchors produced from REJOIN Company, and the control group used PEEK suture anchors from American Arthrex Company. Two patients in control group were lost to follow-up. Twenty-seven patients in trial group and 26 patients in control group were included in the final quantitative analysis. There was no significant difference ( P>0.05) in gender, age, disease duration, side and sizes of rotator cuff tears, composition ratio of patients with type 2 diabetes, and preoperative American Shoulder and Elbow Surgeons (ASES) score, Constant-Murley score, University of California at Los Angeles (UCLA) score, and visual analogue scale (VAS) score. The patients were followed up regularly after operation. The postoperative follow-up included safety evaluation (complications, anchor position, and anchor bone reaction) and effectiveness evaluation (shoulder joint function and pain scores, rotator cuff integrity based on Sugaya classification criteria). 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] ( t=0.535, P=0.595). MRI examination indicated that the repaired tendons were fixed and the anchors did not get loose or torn. At 1 day, 3 months, and 6 months after operation, there was no patient with grade 3-4 anchor bone reaction in the two groups, and there was no significant difference in the bone reaction grading between groups ( P>0.05). After operation, the VAS scores of the two groups gradually decreased, and the ASES scores, Constant-Murley scores, and UCLA scores gradually increased, and there were significant differences between groups at each time point ( P<0.05). There was no significant difference between groups at different time points ( P>0.05). There was no significant difference in Sugaya classification of rotator cuff integrity at 1 day, 3 months, and 6 months after operation between groups ( P>0.05). 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.