Management of normal long head of the biceps tendon in isolated grade-1 supraspinatus tear: Research protocol for a multicenter prospective single-blind randomized study.

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.