PMID- 37423469 OWN - NLM STAT- MEDLINE DCOM- 20240202 LR - 20240226 IS - 1526-3231 (Electronic) IS - 0749-8063 (Linking) VI - 40 IP - 2 DP - 2024 Feb TI - An All-Suture Anchor Offers Equivalent Clinical Performance to an Established Solid Suture Anchor in the Arthroscopic Repair of Rotator Cuff Tears: A Prospective, Randomized, Multicenter Trial With 12-Month Follow-Up. PG - 265-276 LID - S0749-8063(23)00546-7 [pii] LID - 10.1016/j.arthro.2023.06.056 [doi] AB - PURPOSE: To evaluate the safety and efficacy of a next-generation, all-suture anchor in patients undergoing arthroscopic repair of rotator cuff tears, compared with that of an established solid suture anchor. METHODS: Between April 2019 and January 2021, a prospective, comparative, randomized controlled noninferiority study conducted on people with Chinese ethnicity at 3 tertiary hospitals enrolled patients (18-75 years) requiring arthroscopic treatment for rotator cuff tears. Patients were randomized into 2 cohorts receiving either all-suture anchor or solid suture anchor and followed for 12 months. The primary outcome was the Constant-Murley score at the 12-month follow-up. Magnetic resonance imaging assessments determined the rate of retear of rotator cuff repair (defined as Sugaya classification 4 and 5). Safety evaluation was performed at all follow-up points to determine the adverse events (AEs). RESULTS: In total, 120 patients with rotator cuff tears (mean age, 58.3 years; 62.5% female; 60 receiving all-suture anchor) underwent treatment. Five patients were lost to follow-up. Both cohorts showed significant improvement in Constant-Murley scores between baseline and 6 months (P < .001) and between 6 and 12 months (P < .001). There were no significant differences in Constant-Murley scores between the 2 cohorts at 12 months (P = .122) after operation. The retear rate at 12 months was 5.7% and 1.9% in the all-suture and solid suture anchor cohorts, respectively (P = .618). There were 2 cases of intraoperative anchor pullout, both of which were successfully resolved. No cases of postoperative reoperation or other anchor-related AEs were reported. CONCLUSIONS: The all-suture anchor offered equivalent clinical performance to an established solid suture anchor at the 12-month follow-up in patients undergoing arthroscopic repair of rotator cuff tears. The retear rate was not statistically significantly different between the 2 cohorts. LEVEL OF EVIDENCE: Level I, randomized controlled trial. CI - Copyright (c) 2023 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved. FAU - Yan, Hui AU - Yan H AD - Department of Sports Medicine, Peking University Third Hospital, Institute of Sports Medicine of Peking University, and Beijing Key Laboratory of Sports Injuries, Beijing, China. Electronic address: yanhui_bysy@2008.sina.com. FAU - Zhao, Lilian AU - Zhao L AD - Department of Sports Medicine, Foshan Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Foshan, China. FAU - Wang, Jing AU - Wang J AD - Department of Joint Surgery and Sports Medicine, Hunan Provincial People's Hospital (The First-Affiliated Hospital of Hunan Normal University), Changsha, China. FAU - Lin, Lin AU - Lin L AD - Department of Sports Medicine, Peking University Third Hospital, Institute of Sports Medicine of Peking University, and Beijing Key Laboratory of Sports Injuries, Beijing, China. FAU - Wang, Hongtao AU - Wang H AD - Department of Joint Surgery and Sports Medicine, Hunan Provincial People's Hospital (The First-Affiliated Hospital of Hunan Normal University), Changsha, China. FAU - Wang, Changbing AU - Wang C AD - Department of Sports Medicine, Foshan Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Foshan, China. FAU - Yu, Yongpei AU - Yu Y AD - Peking University Health Science Center, Beijing, China. FAU - Lu, Mingfeng AU - Lu M AD - Department of Sports Medicine, Foshan Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Foshan, China. FAU - Xu, Ting AU - Xu T AD - Department of Sports Medicine, Foshan Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Foshan, China. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20230707 PL - United States TA - Arthroscopy JT - Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association JID - 8506498 SB - IM MH - Humans MH - Female MH - Middle Aged MH - Male MH - *Rotator Cuff Injuries/surgery/pathology MH - Rotator Cuff/surgery/pathology MH - Follow-Up Studies MH - Prospective Studies MH - Suture Anchors MH - Magnetic Resonance Imaging MH - Arthroscopy/methods MH - Treatment Outcome MH - Suture Techniques EDAT- 2023/07/10 00:41 MHDA- 2024/02/02 06:43 CRDT- 2023/07/09 19:26 PHST- 2018/12/04 00:00 [received] PHST- 2023/06/23 00:00 [revised] PHST- 2023/06/23 00:00 [accepted] PHST- 2024/02/02 06:43 [medline] PHST- 2023/07/10 00:41 [pubmed] PHST- 2023/07/09 19:26 [entrez] AID - S0749-8063(23)00546-7 [pii] AID - 10.1016/j.arthro.2023.06.056 [doi] PST - ppublish SO - Arthroscopy. 2024 Feb;40(2):265-276. doi: 10.1016/j.arthro.2023.06.056. Epub 2023 Jul 7.