Surgery to transfer the lower trapezius tendon for severe rotator cuff tears
Clinical Results of Arthroscopic-Assisted Lower Trapezius Tendon Transfer for Massive, Irreparable Rotator Cuff Tears
NA · Gazi University · NCT06258278
This study is testing a new surgery that moves a muscle tendon to help people with severe rotator cuff tears feel less pain and improve their shoulder function after six months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Gazi University (other) |
| Locations | 1 site (Ankara) |
| Trial ID | NCT06258278 on ClinicalTrials.gov |
What this trial studies
This study evaluates a modified surgical technique for transferring the lower trapezius tendon in patients with massive, irreparable rotator cuff tears. Patients will be assessed one day before surgery and again six months post-operation to measure pain and shoulder function. Pain intensity will be measured using the Visual Analog Scale (VAS), while shoulder function will be evaluated with the UCLA Shoulder Score and the Constant-Murley Shoulder Score. The goal is to determine the short-term outcomes of this innovative surgical approach.
Who should consider this trial
Good fit: Ideal candidates are individuals with chronic, irreparable rotator cuff tears who have not benefited from conservative treatments.
Not a fit: Patients with glenohumeral arthritis, adhesive capsulitis, or neurological deficits may not benefit from this procedure.
Why it matters
Potential benefit: If successful, this procedure could significantly improve shoulder function and reduce pain for patients with severe rotator cuff injuries.
How similar studies have performed: While this approach is innovative, similar tendon transfer techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with massive, chronic (\>6 months), irreparable rotator cuff tears; * patients with no concomitant irreparable subscapularis tears; * patients who underwent a trial of at least 6-month period of conservative treatment with no benefit; * patients with a stage 3 or greater degree of supraspinatus muscle fatty infiltration; Exclusion Criteria: * patients with glenohumeral arthritis; * patients with adhesive capsulitis or passive joint motion restriction * patients with neurologic deficits
Where this trial is running
Ankara
- Gazi University Hospital — Ankara, Turkey (RECRUITING)
Study contacts
- Principal investigator: Ulunay Kanatlı — Gazi University
- Study coordinator: İnci H Ayas
- Email: inciayass@gmail.com
- Phone: +(312) 202 5599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Massive Irreparable Rotator Cuff Tears, Irreparable Rotator Cuff Tears, Tendon Transfer, Massive Rotator Cuff Tears