RSA Vs RCR for Massive RCTs

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).

Conditions

Rotator Cuff Tears

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Study Overview

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Study Details

Study overview

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).

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

RSA Vs RCR for Massive RCTs

Condition
Rotator Cuff Tears
Intervention / Treatment

-

Contacts and Locations

Portland

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

60 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2027-03-01