Actively Recruiting

Phase Not Applicable
Age: 60Years - 80Years
All Genders
NCT05807854

RSA Vs RCR for Massive RCTs

Led by La Tour Hospital · Updated on 2024-10-26

160

Participants Needed

2

Research Sites

208 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

RSA Vs RCR for Massive RCTs

Who Can Participate

Age: 60Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient voluntarily consents to participate
  • Patient with a massive and reparable non traumatic rotator cuff tears after failure of conservative treatment
  • 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
Not Eligible

You will not qualify if you...

  • Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study
  • Revision rotator cuff repair
  • Patient consent withdrawal
  • Glenohumeral arthritis defined as stage > 3 Hamada classification
  • Infection and neuropathic joints
  • Known or suspected non-compliance, drug or alcohol abuse
  • Patients incapable of judgement or under tutelage
  • Inability to follow the procedures of the study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

2

La Tour hospital

Meyrin, Canton of Geneva, Switzerland, 1217

Actively Recruiting

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Research Team

A

Alexandre Lädermann, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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