Clinical Trial

Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs

Study acronym: ROTATORCUFF
Recruiting
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Summary
This prospective, single-arm interventional study will evaluate the effects of long head of the biceps tendon (LHBT) transposition without tenotomy as an augmentation technique for arthroscopic partial repair in adults with massive rotator cuff tears. Consecutive eligible patients undergoing arthroscopic partial rotator cuff repair plus tenotomy-sparing LHBT transposition augmentation at Balikesir City Hospital (Balikesir, Turkiye) will be enrolled and followed for 12 months. Patient-reported outcomes and clinical assessments will be collected preoperatively (baseline) and postoperatively at 3 and 12 months. The primary outcomes are shoulder function (ASES), rotator cuff-related quality of life (WORC converted to a 0-100 scale), and sleep disturbance (Insomnia Severity Index). Secondary outcomes include active shoulder range of motion and biceps-related clinical findings (Speed test, Yergason test, bicipital groove tenderness, and Popeye deformity). Postoperative MRI will not be obtained routinely and will be performed only if clinically indicated. The study aims to provide standardized prospective data on functional outcomes, quality of life, and sleep after this augmentation approach.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-05-29
notable Primary completion moved earlier: 2027-06-15 -> 2026-05-24 2026-05-29
minor Completion pushed: 2027-07-15 -> 2027-12-15 2026-05-29
Trial Details
NCT Number NCT07375277
Lead Sponsor Ataturk University
Conditions Massive Rotator Cuff Tear
Enrollment 35 participants
Start Date 2026-03-26
Primary Completion 2026-05-24 (estimated)
Study Completion 2027-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-28