Treatment of Degenerative Massive Rotator Cuff Tears: a Multicenter, Randomized Comparative Surgical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Oregon
Oregon Health & Science University
RECRUITING
Portland
Other Locations
Switzerland
La Tour hospital
RECRUITING
Meyrin
Contact Information
Primary
Alexandre Lädermann, MD
alexandre.laedermann@gmail.com
+41 22 71 975 55
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 160
Treatments
Active_comparator: Arthroscopic surgery
The massive degenerative rotator cuff tear are treated by arthroscopy. It consists in reattaching the torn tendon with anchors and sutures.
Experimental: Reverse shoulder arthroplasty
The problems induced by the massive degenerative rotator cuff tear are solved by a complete replacement of the shoulder joint with a prosthesis (reverse design).
Related Therapeutic Areas
Sponsors
Leads: La Tour Hospital

This content was sourced from clinicaltrials.gov