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

NCT07375277 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-01-29

No results posted yet for this 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.

Conditions

  • Massive Rotator Cuff Tear

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Principal Investigators

  • özgün 0 karakuş, M.D · Balikesir Ataturk City Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-06-15
Completion
2027-07-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07375277 on ClinicalTrials.gov