Arthroscopy division, Department of Arthroscopy, Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK B31 2AP, UK.
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Oswestry, UK.
Knee Surg Sports Traumatol Arthrosc. 2023 Jul;31(7):2654-2661. doi: 10.1007/s00167-023-07356-5. Epub 2023 Mar 2.
The aims of this pilot randomised controlled trial (RCT) were to assess the safety and efficacy of a human dermal allograft patch and assess the feasibility of a future RCT comparing retear rate and functional outcome 12 months following standard and augmented double-row rotator cuff repair.
A pilot RCT was conducted among patients undergoing arthroscopic repair of rotator cuff tear measuring between 1 and 5 cm. They were randomised to either augmented (double-row repair with human acellular dermal patch) or standard (double-row repair only). The primary outcome was rotator cuff retear determined on MRI scan at 12 months using the Sugaya's classification (grade 4 or 5). All adverse events were recorded. Functional assessment was performed at baseline and 3, 6, 9, and 12 months post-surgery using clinical outcome scores. Safety was assessed by complications and adverse effects, and feasibility by recruitment, follow-up rate and proof of concept statistical analyses of a future trial.
Between 2017 and 2019, 63 patients were considered for inclusion. Twenty-three patients were excluded, leaving 40 patients (20 per group) in the final study population. The mean tear sizes were 3.0 cm in the augmented and 2.4 cm in the standard group. There was one adhesive capsulitis in the augmented group, with no other adverse events. Retear was observed in 4/18 (22%) of patients in the augmented and 5/18 (28%) in the standard group. In both groups, functional outcome improved significantly which was clinically meaningful for all scores, with no difference between groups. Retear rate increased with tear size. Future trials are feasible but need a minimum total sample size of 150 patients.
Clinically meaningful improved function without adverse effects was found with human acellular dermal patch-augmented cuff repairs.
Level II.
本研究旨在评估人真皮同种异体移植物补片的安全性和有效性，并评估在标准和增强双排肩袖修复后 12 个月比较再撕裂率和功能结果的未来随机对照试验（RCT）的可行性。
在接受关节镜肩袖撕裂修复的患者中进行了一项试点 RCT，肩袖撕裂的大小为 1 至 5cm。他们被随机分为增强组（双排修复+人脱细胞真皮补片）或标准组（仅双排修复）。主要结局是在 12 个月时通过 MRI 扫描根据 Sugaya 分类（4 或 5 级）确定肩袖再撕裂。记录所有不良事件。使用临床结果评分在基线和术后 3、6、9 和 12 个月进行功能评估。通过并发症和不良反应评估安全性，通过招募、随访率和未来试验的概念验证统计分析评估可行性。
在 2017 年至 2019 年间，共有 63 名患者符合纳入标准。23 名患者被排除在外，最终研究人群为 40 名患者（每组 20 名）。增强组的平均撕裂大小为 3.0cm，标准组为 2.4cm。增强组有 1 例粘连性囊炎，无其他不良事件。增强组有 4/18（22%）的患者出现再撕裂，标准组有 5/18（28%）的患者出现再撕裂。两组患者的功能结果均显著改善，所有评分均具有临床意义，组间无差异。再撕裂率随撕裂大小增加而增加。未来的试验是可行的，但需要至少 150 名患者的总样本量。
使用人脱细胞真皮补片增强的肩袖修复可实现无不良反应的临床意义上的功能改善。
II 级。
