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Repair vs Replacement for Rotator Cuff Tears

N/A

Recruiting

Led By Patrick Denard, MD

Research Sponsored by La Tour Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24 post-operative months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two treatments for rotator cuff tear: repair (RCR) or replacement (RSA). Both aim to decrease pain & improve function & quality of life.

Who is the study for?

This trial is for patients with massive, non-traumatic rotator cuff tears that haven't improved with conservative treatment. They must have specific pre-operative images and be able to consent and follow the study procedures. People with advanced shoulder arthritis, previous surgeries, infections, or conditions affecting their ability to participate are excluded.

What is being tested?

The study compares functional outcomes between two treatments for severe rotator cuff injuries: arthroscopic repair (RCR) and reverse shoulder arthroplasty (RSA). It's a prospective randomized study which means participants will be randomly assigned to one of these treatments to see which one works better.

What are the potential side effects?

Potential side effects from RCR may include pain, stiffness, or infection at the surgery site. RSA might lead to similar issues along with possible prosthesis-related problems like loosening or dislocation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 post-operative months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24 post-operative months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 post-operative months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

American Shoulder and Elbow Surgeon (ASES) score

Secondary study objectives

Acromial fracture

Complication

Constant score

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Reverse shoulder arthroplastyExperimental Treatment1 Intervention

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).

Group II: Arthroscopic surgeryActive Control1 Intervention

The massive degenerative rotator cuff tear are treated by arthroscopy. It consists in reattaching the torn tendon with anchors and sutures.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Reverse Shoulder Arthroplasty

2016

N/A

~100

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