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RSA Vs RCR for Massive RCTs

NCT05807854 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-10-26

No results posted yet for this 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).

Conditions

  • Rotator Cuff Tears

Interventions

PROCEDURE

Arthroscopy

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

DEVICE

Reverse Shoulder Arthroplasty

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

Sponsors & Collaborators

  • La Tour Hospital

    lead OTHER

Principal Investigators

  • Alexandre Lädermann, MD · La Tour hospital, Meyrin (1217) Geneva, Switzerland

  • Patrick Denard, MD · Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2027-03-01
Completion
2027-03-01
FDA Device
Yes

Countries

  • United States
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05807854 on ClinicalTrials.gov