RECRUITING

RSA Vs RCR for Massive RCTs

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-03-01
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05807854

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1 Patient voluntarily consents to participate
  2. * 2 Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment
  3. * 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
  1. * 1 Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study
  2. * 2 Revision rotator cuff repair
  3. * 3 Patient consent withdrawal
  4. * 4 Glenohumeral arthritis defined as stage \> 3 Hamada classification
  5. * 5 Infection and neuropathic joints
  6. * 6 Known or suspected non-compliance, drug or alcohol abuse
  7. * 7 Patients incapable of judgement or under tutelage
  8. * 8 Inability to follow the procedures of the study
  9. * 9 Enrolment of the investigator, his/her family members, employees and other dependent persons

Contacts and Locations

Study Contact

Alexandre Lädermann, MD
CONTACT
+41 22 71 975 55
alexandre.laedermann@gmail.com

Principal Investigator

Alexandre Lädermann, MD
PRINCIPAL_INVESTIGATOR
La Tour hospital, Meyrin (1217) Geneva, Switzerland
Patrick Denard, MD
PRINCIPAL_INVESTIGATOR
Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA

Study Locations (Sites)

Oregon Health & Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: La Tour Hospital

  • Alexandre Lädermann, MD, PRINCIPAL_INVESTIGATOR, La Tour hospital, Meyrin (1217) Geneva, Switzerland
  • Patrick Denard, MD, PRINCIPAL_INVESTIGATOR, Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2027-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Rotator Cuff Tears