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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBalikesir Ataturk City Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • LHBT Transposition Augmentation

    Procedure/Surgery

    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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Biceps Transposition AugmentationOther 1 intervention

Trial outcomes

Primary outcomes

1

American Shoulder and Elbow Surgeons (ASES) Score

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.

Time frame
aseline, 3 months, and 12 months postoperatively

Secondary outcomes

Other outcomes

Sponsors and contacts

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