| NCT ID | NCT05807854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | La Tour Hospital |
| Condition | Rotator Cuff Tears |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2023-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Alexandre Lädermann, MD
PRINCIPAL INVESTIGATOR
La Tour hospital, Meyrin (1217) Geneva, Switzerland
Frequently Asked Questions
Who can join the NCT05807854 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 80 Years, studying Rotator Cuff Tears. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05807854 currently recruiting?
Yes, NCT05807854 is actively recruiting participants. Contact the research team at alexandre.laedermann@gmail.com for enrollment information.
Where is the NCT05807854 trial being conducted?
This trial is being conducted at Portland, United States, Meyrin, Switzerland.
Who is sponsoring the NCT05807854 clinical trial?
NCT05807854 is sponsored by La Tour Hospital. The principal investigator is Alexandre Lädermann, MD at La Tour hospital, Meyrin (1217) Geneva, Switzerland. The trial plans to enroll 160 participants.