Departments of Surgery and Physical Therapy, University of Western Ontario, London, Ontario, Canada; Roth McFarlane Hand and Upper Limb Centre, St. Joseph's Health Care, London, Ontario, Canada.
Investigation performed at the University of Western Ontario, London, Ontario, Canada.
Am J Sports Med. 2021 Oct;49(12):3184-3195. doi: 10.1177/03635465211038233. Epub 2021 Sep 15.
Patients with complete rotator cuff tears who fail a course of nonoperative therapy can benefit from surgical repair.
This randomized trial compared mini-open (MO) versus all-arthroscopic (AA) rotator cuff repair.
Randomized controlled trial; Level of evidence, 1.
Patients with rotator cuff tears were randomized to undergo MO or AA repair at 9 centers by 23 surgeons. The primary outcome (Western Ontario Rotator Cuff Index [WORC]) and secondary outcomes (American Shoulder and Elbow Surgeons [ASES] score, Shoulder Pain and Disability Index [SPADI] pain subscale, 12-Item Short Form Health Survey [SF-12], reported medication use, adverse events), as well as measurements of range of motion and strength, were collected at 1 month before surgery; at 2 and 6 weeks postoperatively; and at 3, 6, 12, 18, and 24 months postoperatively. A blinded radiologist evaluated rotator cuff integrity on magnetic resonance imaging (MRI) at baseline and 1 year. Intention-to-treat analysis of covariance with the preoperative WORC score, age, and tear size as covariates assessed continuous outcomes. Sex differences were assessed. A meta-analysis synthesized the primary outcome between MO and AA repair with previous trials.
From 954 patients screened, 411 were ineligible (276 because of recovery with physical therapy), 449 were screened at surgery (175 ineligible), and 274 completed follow-up (138 MO and 136 AA). The AA and MO groups were similar before surgery. WORC scores improved from 40 preoperatively to 89 (AA) and 93 (MO) at 2 years, for an adjusted mean difference of 3.4 (95% CI, -0.4 to 7.2). There were no statistically significant differences between the AA and MO groups at any time point. All secondary patient-reported outcomes were not significantly different between the MO and AA groups, except the 2-year SPADI pain score (8 vs 12, respectively; = .02). A similar recovery in range of motion and strength occurred in both groups over time. MRI indicated minimal improvement in muscle relative to fat (AA: n = 3; MO: n = 2), with most worsening (AA: n = 25; MO: n = 24) or remaining unchanged (AA: n = 70; MO: n = 70). Opioid use was significantly reduced after surgery (from 21% to 5%). The meta-analysis indicated no significant standardized mean difference between groups in the primary outcome across all pooled studies (standardized mean difference, -0.06 [95% CI, -0.34 to 0.22]).
Both AA and MO rotator cuff repair provide large clinical benefits, with few adverse events. There is strong evidence of equivalent clinical improvements.
NCT00128076.
经非手术治疗失败的完全性肩袖撕裂患者可从手术修复中获益。
本随机试验比较了微创（MO）与全关节镜（AA）肩袖修复。
随机对照试验；证据水平，1 级。
9 个中心的 23 位外科医生将肩袖撕裂患者随机分为 MO 或 AA 修复组。主要结局（Western Ontario Rotator Cuff Index [WORC]）和次要结局（美国肩肘外科医师协会 [ASES]评分、肩痛和残疾指数 [SPADI]疼痛子量表、12 项简明健康调查量表 [SF-12]、报告的药物使用、不良事件），以及术前 1 个月、术后 2 周和 6 周；术后 3、6、12、18 和 24 个月；术后运动范围和力量测量值；由盲法放射科医生在基线和 1 年时使用磁共振成像（MRI）评估肩袖完整性。采用协方差分析的意向治疗分析，以术前 WORC 评分、年龄和撕裂大小为协变量评估连续结局。评估了性别差异。对 MO 和 AA 修复与以往试验的主要结局进行了荟萃分析。
从筛选的 954 名患者中，411 名患者不符合条件（276 名因物理治疗而康复），449 名在手术时进行了筛选（175 名不符合条件），274 名完成了随访（138 名 MO 和 136 名 AA）。AA 和 MO 组在术前相似。WORC 评分从术前的 40 分提高到 2 年时的 89 分（AA）和 93 分（MO），调整后的平均差异为 3.4（95%CI，-0.4 至 7.2）。在任何时间点，AA 和 MO 组之间均无统计学显著差异。除 2 年 SPADI 疼痛评分（分别为 8 分和 12 分；P =.02）外，MO 和 AA 组的所有次要患者报告结局均无显著差异。两组的运动范围和力量随时间均有相似的恢复。MRI 显示肌肉相对于脂肪的改善较小（AA：n = 3；MO：n = 2），大多数（AA：n = 25；MO：n = 24）或保持不变（AA：n = 70；MO：n = 70）。手术后阿片类药物的使用显著减少（从 21%降至 5%）。荟萃分析表明，所有汇总研究中组间主要结局的标准化均数差值无统计学意义（标准化均数差值，-0.06[95%CI，-0.34 至 0.22]）。
AA 和 MO 肩袖修复均提供了显著的临床获益，且不良事件较少。有强有力的证据表明临床改善相当。
NCT00128076。
