Actively Recruiting
RSA Vs RCR for Massive RCTs
Led by La Tour Hospital · Updated on 2024-10-26
160
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
RSA Vs RCR for Massive RCTs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
2
La Tour hospital
Meyrin, Canton of Geneva, Switzerland, 1217
Actively Recruiting
Research Team
A
Alexandre Lädermann, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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