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Clinical Trials in Switzerland / NCT05807854
Recruiting Not applicable

RSA Vs RCR for Massive RCTs

NCT05807854 · tracked via the Priya Life Science Switzerland tracker
Sponsor
La Tour Hospital
Phase
Not applicable
Started
2023-03-01
Last updated
2024-10-26

Condition(s) studied

Rotator Cuff Tears

Investigational drug(s) / intervention(s)

ArthroscopyReverse Shoulder Arthroplasty

Arthroscopy: The surgeon reattaches the torn tendon to the bone with anchors and sutures.

Reverse Shoulder Arthroplasty: It consists in replacing the shoulder joint with a total shoulder prosthesis (reverse design).

Study 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

Sex
ALL
Min age
60 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Oregon Health & Science University Portland Oregon Recruiting
La Tour hospital Meyrin Canton of Geneva Recruiting

More La Tour Hospital trials in Switzerland

Anatomic TSA vs RTSA for Glenohumeral Arthritis Recruiting
Exploring the Evolution of Quality of Life and Emotional Distress Among Cancer Patients Participating in Mind-body Therapies Enrolling by invitation
Virtual Reality Rehabilitation for Shoulder Pathologies Recruiting
Treatment of the Biceps With Concomitant Supraspinatus Tears Recruiting

Other trials for the same condition

Virtual Reality Rehabilitation for Shoulder Pathologies Recruiting
Patch Study (Patch-augmented Rotator Cuff Repair) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05807854 on ClinicalTrials.gov ↗ ← All trials in Switzerland