Harris Ian A, Page Richard S, Buchbinder Rachelle, Äärimaa Ville, Adie Sam, Brown Graeme, Cinnadaio Nancy, Damiani Maurizio, Descallar Joseph, Ferreira Manuela L, Foster Nadine E, Gill Stephen, Hutchison Katrina, Järvinen Teppo, Khoo Oliver, Lieu David, Maher Christopher G, Naylor Justine M, Smith Geoff, Spencer Luke, Toh Yvana, Whan Andrew, Yeoh Tim
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, Australia.
School of Clinical Medicine, Faculty of Medicine & Health, UNSW Sydney, PO Box 1274 Darlinghurst, Liverpool, NSW, 1300, Australia.
Trials. 2025 Apr 2;26(1):116. doi: 10.1186/s13063-025-08822-w.
Degenerative rotator cuff tears are common and are often treated with surgical repair. Randomised trials have not shown a clear advantage to surgery over non-surgical treatment, but there have been no published placebo-controlled trials investigating rotator cuff repair. This study aims to compare arthroscopic shoulder surgery with rotator cuff repair to surgery without rotator cuff repair (placebo) for improving shoulder pain and function in people with shoulder pain and full-thickness degenerative rotator cuff tears.
The study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). Participants will be people aged 40-75 years (inclusive) with more than 6 months of shoulder pain, a degenerative (non-traumatic) full thickness rotator cuff tear 1 to 4 cm in length for whom surgery is recommended and repair of the tear is the main reason for surgery. The intervention is arthroscopic surgery (including-as indicated-bursectomy, debridement, acromioclavicular joint resection, acromioplasty and biceps tenodesis or tenotomy) with rotator cuff repair. The control is the same arthroscopic shoulder surgery without rotator cuff repair. Participants will be randomised to cuff repair or no cuff repair in a 1:1 ratio intra-operatively, after all other surgical procedures have been performed. Participants, follow-up surgeons, physiotherapists, study staff and statisticians will be blinded. Post-surgical rehabilitation will be usual care for rotator cuff repair in both groups. The primary outcome will be shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery.
The ARC trial will provide low bias evidence on a common surgical procedure: rotator cuff repair for degenerative tears.
The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599).
退行性肩袖撕裂很常见，通常采用手术修复治疗。随机试验并未显示手术相对于非手术治疗有明显优势，但尚无已发表的关于肩袖修复的安慰剂对照试验。本研究旨在比较关节镜下肩袖修复手术与无肩袖修复手术（安慰剂手术）对改善肩痛和全层退行性肩袖撕裂患者肩部功能的效果。
本研究是一项多中心、双平行组、盲法、个体随机对照试验（RCT）。参与者为年龄在40 - 75岁（含）之间、肩痛超过6个月、有1至4厘米长的退行性（非创伤性）全层肩袖撕裂且建议手术治疗且撕裂修复是手术主要原因的患者。干预措施为关节镜手术（包括视情况进行滑囊切除术、清创术、肩锁关节切除术、肩峰成形术和肱二头肌固定术或肌腱切断术）并进行肩袖修复。对照组为相同的关节镜下肩部手术但不进行肩袖修复。在所有其他手术操作完成后，参与者将在术中以1:1的比例随机分配至肩袖修复组或无肩袖修复组。参与者、随访外科医生、物理治疗师、研究人员和统计人员都将处于盲态。两组术后康复均采用肩袖修复的常规护理。主要结局指标将是术后6个月使用西 Ontario 肩袖指数测量的肩部疼痛和功能。
ARC 试验将为一种常见的外科手术——退行性撕裂的肩袖修复术提供低偏倚证据。
该试验于2020年8月5日在澳大利亚新西兰临床试验注册中心（ACTRN12620000789965）注册，并在世界卫生组织国际临床试验注册平台（通用试验编号 U1111 - 1251 - 6599）注册。
