Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs (NCT07375277) | Clinical Trial Compass
RecruitingNot Applicable
Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs
Turkey (Türkiye)35 participantsStarted 2026-03-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
American Shoulder and Elbow Surgeons (ASES) Score
Timeframe: aseline, 3 months, and 12 months postoperatively