Background

The long head of the biceps (LHB) tendon is a common locus of pain in rotator cuff tear and of residual pain after tendon repair. Therefore, systematic LHB tenotomy, with or without tenodesis, is usually recommended. However, the recent literature suggests that long-term functional results of supraspinatus tendon repair are comparable between conservation of a normal biceps and tenotomy. The study objective is to compare functional results between sectioning and sparing a normal LHB in treating isolated grade-1 supraspinatus tendon tear. The study hypothesis is that sparing the normal LHB is clinically preferable to sectioning in the particular case of distal supraspinatus tear.

Methods and analysis

A French nationwide prospective single-blind randomized clinical study will include 194 patients undergoing arthroscopic repair of grade-1 supraspinatus tear with normal LHB. They will be randomized to 2 parallel groups: LHB sparing and sectioning. The main endpoint is Constant-Murley score, and secondary endpoints comprise ASES and SSV scores, clinical assessment of the biceps, pain on VAS, ultrasound assessment of cuff repair healing and conserved LHBs, impact on return to work and sport, pathologic assessment of sectioned LHBs, and analysis of risk factors for cuff repair failure.

Ethical approval and publication

The protocol has been approved by the data protection committee (art.L.1122-1) and meets the criteria of the Declaration of Helsinki and of the SPIRIT statement defining standard protocol items for clinical trials. Results will be published in a peer-reviewed journal.

Level of evidence

not applicable.

中文翻译：

---

孤立性 1 级冈上肌撕裂中正常二头肌长头肌腱的处理：多中心前瞻性单盲随机研究的研究方案

背景

二头肌长头 (LHB) 肌腱是肩袖撕裂和肌腱修复后残留疼痛的常见疼痛部位。因此，通常建议进行系统的 LHB 肌腱切断术，无论是否进行肌腱固定术。然而，最近的文献表明，冈上肌肌腱修复的长期功能结果在保留正常二头肌和肌腱切断术之间具有可比性。研究目的是比较切片和保留正常 LHB 治疗孤立的 1 级冈上肌腱撕裂的功能结果。研究假设是，在冈上肌远端撕裂的特殊情况下，保留正常的 LHB 在临床上比切片更可取。

方法与分析

一项法国全国前瞻性单盲随机临床研究将包括 194 名接受关节镜修复 1 级冈上肌撕裂且 LHB 正常的患者。他们将被随机分配到 2 个平行组：LHB 保留和切片。主要终点是 Constant-Murley 评分，次要终点包括 ASES 和 SSV 评分、二头肌的临床评估、VAS 疼痛、袖带修复愈合和保守 LHB 的超声评估、对重返工作和运动的影响、切片的病理评估LHBs，以及袖带修复失败的危险因素分析。

伦理批准和出版

该协议已获得数据保护委员会 (art.L.1122-1) 的批准，并符合赫尔辛基宣言和定义临床试验标准协议项目的 SPIRIT 声明的标准。结果将发表在同行评审的期刊上。

证据等级

不适用。