Department of Orthopedics, The People's Hospital of Beilun district of Ningbo, Zhejiang, China.
Medicine (Baltimore). 2021 Mar 12;100(10):e24965. doi: 10.1097/MD.0000000000024965.
There have been no published randomized clinical trial to assess the clinical outcomes between the articular-sided and bursal-sided tears. Therefore, a comparative analysis of evaluating and comparing the functional outcomes following arthroscopic repair of bursal-sided versus articular-sided partial-thickness rotator cuff tearsis essential.
This study is a present randomized controlled trial which is conducted in our hospital. Consecutive patients with symptomatic articular-sided or bursal-sided partial-thickness rotator cuff tears underwent arthroscopic repair between June 2020 and January 2022. The institutional review board approved the study proposal (with number 10012030), and informed consent was obtained from all patients. Inclusion criteria were existence of an articular- or bursal-sided tear involving <50% of the tendon thickness-confirmed intraoperatively and treated with arthroscopic debridement with or without other decompression surgery (acromioplasty/distal clavicle resection)-and a minimum follow-up of 2 years. All patients followed the same postoperative rehabilitation program. The patients were assessed at baseline preoperatively, and at 1 year and 2 years postoperatively. Outcome parameters were measured at each respective follow-up, which included active range of motion in forward flexion and abduction of the affected shoulder, pain score as measured on the Numeric Pain Rating Scale, as well as outcome scores in terms of the Constant-Murley Score, and Oxford Shoulder Score.
Table 1 and Table 2 describe the data indicators that this article wants to evaluate and collect.
We hypothesize that both groups of patients will show improvement in range of motion, functional outcome scores, and pain at 2 years, and that results would be similar between the two groups.
This study protocol was registered in Research Registry (researchregistry6496).
目前尚无关于关节侧和滑囊侧撕裂的随机临床试验来评估其临床结果。因此，评估和比较关节侧和滑囊侧部分厚度肩袖撕裂的关节镜修复后的功能结果的对比分析至关重要。
本研究为在我院进行的前瞻性随机对照试验。2020 年 6 月至 2022 年 1 月期间，连续就诊的症状性关节侧或滑囊侧部分厚度肩袖撕裂患者接受了关节镜修复。机构审查委员会批准了该研究方案（编号 10012030），并获得了所有患者的知情同意。纳入标准为术中证实存在关节侧或滑囊侧撕裂，累及肌腱厚度的<50%，并采用关节镜清创术治疗，或联合其他减压手术（肩峰成形术/远端锁骨切除术）；并且至少随访 2 年。所有患者均遵循相同的术后康复方案。患者在术前、术后 1 年和 2 年进行评估。在每次随访时测量结果参数，包括受累肩部的前屈和外展主动活动度、数字疼痛评分量表上的疼痛评分、Constant-Murley 评分和牛津肩袖评分的功能评分。
表 1 和表 2 描述了本文想要评估和收集的数据指标。
我们假设两组患者在 2 年时的活动范围、功能结果评分和疼痛均会有所改善，且两组之间的结果相似。
本研究方案在 Research Registry（researchregistry6496）注册。
