NCT05807854 · La Tour Hospital
RSA Vs RCR for Massive RCTs
What this study 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.
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Portland, Oregon
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 26, 2024 · Source of record for eligibility and locations