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RSA Vs RCR for Massive RCTs

RecruitingNAAges 60 Years - 80 YearsAllLa Tour Hospital
NCT05807854 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Different treatment options are available for massive or irreparable rotator cuff tears. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).

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📋 Eligibility rules (as published)
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
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What it tests

  • Arthroscopy
  • Reverse Shoulder Arthroplasty
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Where

2 sites
Oregon Health & Science University
Portland, United States
La Tour hospital
Meyrin, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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