All-suture soft anchors versus metal anchors in arthroscopic rotator cuff repair: a multicenter randomized clinical trial

Background: The study investigates the safety and efficacy of all-suture soft anchors (ASSA) versus metal anchors (MA) in patients undergoing arthroscopic rotator cuff repair (ARCR) through a randomized controlled trial, assessing whether ASSA’s advantages – reduced bone loss and simplified deployment – can achieve non-inferior clinical outcomes compared to conventional MA. Materials and methods: We conducted a multicenter randomized controlled trial at five Chinese tertiary hospitals (Jan–Oct 2022), with final follow-up in December 2023. Eligible patients had small-to-medium full-thickness rotator cuff tears, Ellman III bursal-side tears, or Lafosse I–IV subscapularis tears. Participants were randomized 1:1 to ARCR with ASSA or MA, followed at 6 weeks, 3, 6, and 12 months. The outcome was included Constant–Murley Score (CMS), American shoulder and elbow surgeons (ASES) score, visual analog scale (VAS) pain, passive range of motion (PROM), and radiographic assessments (postoperative, 6/12 months). All adverse events were recorded. Finally, 87 patients were randomized (ASSA = 43, MA = 44) and 85 received allocated treatment (42 vs 43). Results: ASSA showed better midterm (6-month) functional recovery ( P = 0.031) and pain reduction ( P = 0.005). There was no difference in ASES, VAS, or adverse events (all P > 0.05). After 12 months, both groups showed improved CMS ( P < 0.001), with no between-group difference ( P = 0.900). No anchor dislocations observed. Conclusion: ASSA showed comparable safety and efficacy to MA in ARCR after 12 months of follow-up, with superior improvement in early functional recovery and pain alleviation in midterm (6-month) functional recovery and pain relief, supporting its use as an alternative suture anchor for ARCR.