Comparing two treatments for massive rotator cuff tears
Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | La Tour Hospital Academic / other |
| Locations | 2 sites (Portland, Oregon and 1 other locations) |
| Trial ID | NCT05807854 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Portland, Oregon and 1 other locations
- 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
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.