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

NCT07375277 · tracked via the Priya Life Science Turkey tracker

Sponsor

Balikesir Ataturk City Hospital

Phase

Not applicable

Started

2026-03-26

Last updated

2026-08-31

Condition(s) studied

Massive Rotator Cuff Tear

Investigational drug(s) / intervention(s)

LHBT Transposition Augmentation

LHBT Transposition Augmentation: Arthroscopic partial rotator cuff repair augmented with transposition of the intact long head of the biceps tendon (LHBT) without tenotomy. The transverse humeral ligament is released to mobilize the tendon, which is transposed and fixed to the greater tuberosity footprint using a standardized anchor/suture technique to support the partial repair. Procedures are performed under a standardized surgical and postoperative rehabilitation protocol.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

American Shoulder and Elbow Surgeons (ASES) Score — aseline, 3 months, and 12 months postoperatively
The ASES score is a validated patient-reported outcome measure assessing shoulder pain and function on a 0-100 scale, with higher scores indicating better shoulder function.

Trial sites (1)

Facility	City	Region	Status
Güneş Sarıkaya	Balıkesir	Turkey (Türkiye)	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07375277 on ClinicalTrials.gov ↗ ← All trials in Turkey