RSA Vs RCR for Massive RCTs
Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial
La Tour Hospital
160 participants
Mar 1, 2023
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria3
- Patient voluntarily consents to participate
- Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment
- 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 Criteria9
- Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study
- Revision rotator cuff repair
- Patient consent withdrawal
- Glenohumeral arthritis defined as stage > 3 Hamada classification
- 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
- Enrolment of the investigator, his/her family members, employees and other dependent persons
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Interventions
The surgeon reattaches the torn tendon to the bone with anchors and sutures.
It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).
Locations(2)
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NCT05807854