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

NCT07375277 | Not Yet Recruiting DMC

• 1 other identifier: BCH-BTA-MRCR-2026-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Massive Rotator Cuff Tear

Keywords

Biceps Transposition; Massive Rotator Cuff Tear; Arthroscopic Partial Repair

Outcome Measures

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.

  aseline, 3 months, and 12 months postoperatively

Study Arms (1)

Biceps Transposition Augmentation

OTHER

Participants in this single arm undergo arthroscopic partial rotator cuff repair augmented with tenotomy-sparing transposition of the long head of the biceps tendon (LHBT). All procedures are performed according to a standardized surgical and rehabilitation protocol.

Procedure: LHBT Transposition Augmentation

Interventions

LHBT Transposition Augmentation PROCEDURE

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.

Biceps Transposition Augmentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Güneş Sarıkaya

Balıkesir, Turkey (Türkiye)

Location

Study Officials

• özgün 0 karakuş, M.D

  Balikesir Ataturk City Hospital

  STUDY DIRECTOR

Central Study Contacts

gunes 0 SARIKAYA, M.D

CONTACT

05436733113; gunessarikaya05@hotmail.com

gunes SARIKAYA

CONTACT

05436733113

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label, single-arm interventional study. Due to the nature of the surgical intervention, participants, care providers, investigators, and outcome assessors are not masked.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BALIKESİR CİTY HOSPİTAL

Model Details: Single-arm, single-group study in which all participants undergo arthroscopic partial rotator cuff repair augmented with tenotomy-sparing long head of the biceps tendon (LHBT) transposition, with outcomes assessed at baseline, 3 months, and 12 months.

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 29, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)