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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
American Shoulder and Elbow Surgeon (ASES) score
Secondary outcome measures
Acromial fracture
Complication
Constant score
+12 moreTrial 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
Find a Location
Who is running the clinical trial?
La Tour HospitalLead Sponsor
14 Previous Clinical Trials
245,984 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
4,873 Patients Enrolled for Rotator Cuff Tears
Patrick Denard, MDPrincipal InvestigatorDepartment of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA
Alexandre Lädermann, MDPrincipal InvestigatorLa Tour hospital, Meyrin (1217) Geneva, Switzerland
5 Previous Clinical Trials
5,429 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
4,873 Patients Enrolled for Rotator Cuff Tears
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to make decisions for myself.I am having a second surgery on my rotator cuff.My shoulder arthritis is severe, according to Hamada classification.I have infections or nerve damage in my joints.I agree to join the study willingly.I have a large shoulder tendon tear that didn't improve with basic treatments.I have had specific X-rays and an MRI that show no signs of injury.
Research Study Groups:
This trial has the following groups:- Group 1: Arthroscopic surgery
- Group 2: Reverse shoulder arthroplasty
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being involved in this experiment?
"Affirmative. According to the clinicaltrials.gov database, this trial is presently enrolling participants. It was created on March 1st of 2023 and recently updated towards the end of that month. 160 patients must be recruited from 2 different medical centres for this study to succeed."
Answered by AI
Does the study accept participants below age 65?
"For this clinical study, individuals must be between the age of 60 and 80 to participate."
Answered by AI
Are there any opportunities to participate in this experiment at the moment?
"This clinical study, which was published on March 1st 2023 and amended most recently on the 29th of March, is currently looking for research participants."
Answered by AI
Could I qualify to join this research trial?
"To qualify for this trial, volunteers must suffer from rotator cuff tears and be between 60 to 80 years old. Thus far, 160 participants have been enrolled into the experiment."
Answered by AI
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