Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs
Recruiting now · Not applicable
Conditions studied: Massive Rotator Cuff Tear
In brief
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.
Key facts
- Study ID
- NCT07375277
- Run by
- Ataturk University
- People needed
- 35
- Starts
- 2026-03-26
- Expected to finish
- 2027-12-15
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older
- Diagnosis of a massive rotator cuff tear on preoperative MRI, defined as a full-thickness tear involving at least two tendons and/or a tear with a greatest dimension greater than 5 cm
- Planned arthroscopic partial rotator cuff repair with augmentation using tenotomy-sparing long head of the biceps tendon (LHBT) transposition
- Persistence of symptoms despite at least 3 months of standard nonoperative treatment
- Intact LHBT confirmed intraoperatively
- Willingness and ability to attend scheduled follow-up visits (baseline, 3 months, and 12 months)
- Provision of written informed consent
You may not qualify if…
- Exclusion Criteria:
- Tear patterns not requiring augmentation (e.g., preserved rotator cable patterns)
- Neurologic conditions, inflammatory arthritis, active infection, or systemic conditions that may affect shoulder function or prevent protocol rehabilitation
- Inability to provide informed consent
- Expected nonadherence to follow-up or rehabilitation protocol
Where it is running
- Güneş Sarıkaya — Balıkesir, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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