Comparing treatments for biceps tendon issues in shoulder surgery
Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial
NA · La Tour Hospital · NCT05660031
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | La Tour Hospital (other) |
| Locations | 4 sites (Ann Arbor, Michigan and 3 other locations) |
| Trial ID | NCT05660031 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 80 with a full-thickness tear of the supraspinatus tendon and an intact subscapularis tendon.
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.
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 performed: Previous studies have shown varying results for tenotomy and tenodesis, indicating that this trial's comparative approach is both relevant and necessary.
Eligibility criteria
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 this trial is running
Ann Arbor, Michigan and 3 other locations
- 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
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: Supraspinatus Tear, Long head of the biceps, Supraspinatus tear, tenotomy, tenodesis, rotator cuff repair