Comparing two treatments for massive rotator cuff tears
Official title: Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial
Run by La Tour Hospital · NCT05807854 · Data updated 2026-11-12
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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years to 80 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | La Tour Hospital Academic / other |
| Locations | 2 sites (Portland, Oregon and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | October 26, 2024 |
| Trial ID | NCT05807854 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals over 60 years old with massive and reparable non-traumatic rotator cuff tears who have not responded to conservative treatment.
✕Probably not a fit
Patients with glenohumeral arthritis stage > 3, revision rotator cuff repairs, or those with significant co-morbidities 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 aims to compare the functional outcomes of two treatment options for massive rotator cuff tears: reverse shoulder arthroplasty (RSA) and rotator cuff repair (RCR). It is a prospective multicentric randomized study that includes patients over 60 years of age who have experienced failure of conservative treatment. Participants will undergo either RSA or RCR, and their outcomes will be assessed to determine which approach yields better results in terms of pain relief and shoulder function. The study will utilize pre-operative imaging to ensure appropriate patient selection.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective treatment for patients with massive rotator cuff tears, potentially improving their quality of life.
How similar studies have gone: While there have been various approaches to treating rotator cuff tears, this specific comparison of RSA versus RCR is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1 Patient voluntarily consents to participate * 2 Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment * 3 Patients with the following pre-operative images: Three standardized X-rays series and Magnetic Resonance Imaging (MRI) or arthro Magnetic Resonance Imaging without sign of traumatic lesions Exclusion Criteria: * 1 Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study * 2 Revision rotator cuff repair * 3 Patient consent withdrawal * 4 Glenohumeral arthritis defined as stage \> 3 Hamada classification * 5 Infection and neuropathic joints * 6 Known or suspected non-compliance, drug or alcohol abuse * 7 Patients incapable of judgement or under tutelage * 8 Inability to follow the procedures of the study * 9 Enrolment of the investigator, his/her family members, employees and other dependent persons
Where it's running
-
Oregon Health & Science University
Portland, Oregon, United States Recruiting -
La Tour hospital
Meyrin, Canton of Geneva, Switzerland Recruiting
Study contacts
- Principal investigator: Alexandre Lädermann, MD — La Tour hospital, Meyrin (1217) Geneva, Switzerland
- 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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Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears
This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.
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This study tests whether biomarkers in shoulder tissue and synovial fluid can predict whether a rotator cuff repair will heal, using MRI after surgery to compare those who heal with those who don’t.
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This study sees if people under 65 who had cervical radiculopathy before rotator cuff repair have different shoulder function and quality of life after surgery compared with those who did not.
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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.