Comparing treatments for biceps tendon issues in shoulder surgery
Official title: Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial
Run by La Tour Hospital · NCT05660031 · Data updated 2026-11-12
This study is testing whether two different surgical methods for fixing biceps tendon issues during shoulder surgery can help people aged 50 to 80 recover better after their rotator cuff repair.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 80 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | La Tour Hospital Academic / other |
| Locations | 4 sites (Ann Arbor, Michigan and 3 other locations) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | April 25, 2025 |
| Trial ID | NCT05660031 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 50 to 80 with a full-thickness tear of the supraspinatus tendon and an intact subscapularis tendon.
✕Probably not a fit
Patients with previous full-thickness biceps tears, infections, or those unable to comply with study protocols may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of two surgical approaches, tenotomy and tenodesis, for treating the long head of the biceps tendon in patients undergoing rotator cuff repair for a full-thickness supraspinatus tear. The study aims to determine which method provides better post-operative functional outcomes. Participants will be randomly assigned to one of the treatment groups, and their recovery will be monitored through follow-up visits and questionnaires. The trial includes patients aged 50 to 80 with specific eligibility criteria to ensure a focused evaluation of the interventions.
Why it matters
Potential benefit: If successful, this study could help identify the most effective surgical approach for improving shoulder function and reducing pain in patients with rotator cuff injuries.
How similar studies have gone: Previous studies have shown varying results for tenotomy and tenodesis, indicating that this trial's comparative approach is both relevant and necessary.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy. * Full thickness tear of the supraspinatus tendon * Intact subscapularis tendon * Primary rotator cuff repair * Age 50-80 Exclusion Criteria: * Previous full thickness biceps tear * Infection and neuropathic joints * Known or suspected non-compliance, drug or alcohol abuse * Patients incapable of judgement or under tutelage * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc. * Enrolment of the investigator, his/her family members, employees and other dependent persons * Patient declines to participate in study
Where it's running
-
Sports Medicine and Shoulder Surgery, University of Michigan
Ann Arbor, Michigan, United States Recruiting -
Oregon Health & Science University
Portland, Oregon, United States Recruiting -
Group 23 Sports Medicine
Calgary, Alberta, Canada Recruiting -
la Tour hospital
Meyrin, Canton of Geneva, Switzerland Recruiting
Study contacts
- Principal investigator: Alexandre Lädermann, MD — La Tour Hospital
- Study coordinator: Alexandre Lädermann, MD
- Email: alexandre.laedermann@gmail.com
- Phone: +41 22 71 975 55
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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New treatment for partial rotator cuff tears
This study is testing a new procedure called ultrasonic tenotomy to see if it can help people with partial rotator cuff tears feel less pain and move their shoulders better.
-
Using virtual reality to help rehabilitate shoulder injuries
This study tests whether using virtual reality can make shoulder rehabilitation more engaging and effective for people with shoulder injuries.
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Comparing two treatments for massive rotator cuff tears
This study is testing which treatment, reverse shoulder surgery or shoulder repair, works better for older patients with severe rotator cuff tears that didn't get better with other methods.
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This study is testing whether a new type of shoulder surgery can help people with arthritis just as much as the standard surgery over two years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.