RSA Vs RCR for Massive RCTs

Recruiting now · Not applicable

Conditions studied: Rotator Cuff Tears

In brief

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).

Key facts

Study ID

NCT05807854

Run by

La Tour Hospital

People needed

160

Starts

2023-03-01

Expected to finish

2027-03-01

Last updated by the study team

2024-10-26

Who can join

Age: 60 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• La Tour hospital — Meyrin, Canton of Geneva, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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