Biceps Transposition Without Tenotomy to Augment Massive Rotator Cuff Repairs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm interventional study at Balikesir City Hospital in Turkiye. Adults with massive rotator cuff tears undergoing arthroscopic partial repair will receive a tenotomy-sparing LHBT transposition as an augmentation and will be followed for 12 months. Outcomes include patient-reported measures of shoulder function (ASES), rotator cuff–specific quality of life, sleep quality, and clinician-assessed range of motion. MRI will not be used for postoperative assessment in this protocol. Data will be collected preoperatively and at 3 and 12 months to describe changes over time.

Why it matters

Who can join: the full rules

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

Where it's running

• Güneş Sarıkaya
  Balıkesir, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: gunes 0 SARIKAYA, M.D
• Email: gunessarikaya05@hotmail.com
• Phone: 05436733113

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.