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Non-Operative Treatment vs. Surgery for Rotator Cuff Tears
N/A
Waitlist Available
Led By Peter B MacDonald, MD FRCSC
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is over 18 years of age
Patient has a high-grade (>50%) partial-thickness or small (<1cm) full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare surgery at the time of diagnosis to rehabilitation +/- surgery to see which leads to shorter times to claim closure for workers with high grade partial thickness or small full thickness rotator cuff tears.
Who is the study for?
This trial is for individuals over 18 with an active Workers Compensation Board claim and a specific type of shoulder injury (high-grade partial or small full-thickness tear in certain muscles). They must be able to understand English, have a stable address, and commit to follow-ups. Those with previous surgery on the affected shoulder, other severe shoulder issues, or major health problems are excluded.Check my eligibility
What is being tested?
The study compares two approaches for managing rotator cuff tears: immediate surgery versus rehabilitation with potential delayed surgery if needed. The goal is to see which method leads to quicker claim closure and return to work, considering individual characteristics that might influence outcomes.See study design
What are the potential side effects?
Potential side effects from non-operative treatment could include persistent pain or limited mobility. Surgery risks may involve infection, anesthesia complications, prolonged recovery time, stiffness or failure of the repair.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
Select...
I have a significant tear in my shoulder tendon confirmed by an MRI or similar test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to return to final work status
Secondary outcome measures
Demographics
Orebro Questionnaire
Range of Motion
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Non Operative ManagementExperimental Treatment1 Intervention
Participants will undergo non operative care for as long as they are improving, and will return to the surgeon when no progression is reached.
Group II: Expedited SurgeryExperimental Treatment1 Intervention
Participants will have surgery within 3 months
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,378 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
160 Patients Enrolled for Rotator Cuff Tears
University of AlbertaOTHER
888 Previous Clinical Trials
384,814 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
379 Patients Enrolled for Rotator Cuff Tears
Peter B MacDonald, MD FRCSCPrincipal InvestigatorUniversity of Manitoba Faculty of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a minor tear in my shoulder tendon.I have a tear larger than 1cm in my shoulder muscle.I have had shoulder surgery before.I have had a major injury, infection, or bone death in my joints.I have shoulder damage confirmed by an imaging test.I have a long-term shoulder dislocation, inflammation, or arthritis.I have a serious illness and am expected to live less than 2 years.I am unwilling to attend follow-up appointments.I am over 18 years old.I have a significant tear in my shoulder tendon confirmed by an MRI or similar test.I have a complete tear in my shoulder's subscapularis or teres minor muscle.
Research Study Groups:
This trial has the following groups:- Group 1: Non Operative Management
- Group 2: Expedited Surgery
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.
Are recruitment efforts currently underway for this experiment?
"Contrary to what is posted on clinicaltrials.gov, this medical trial has ceased recruiting patients and was last updated in December 2011. Nevertheless, there are 105 other studies presently requesting participants at the moment."
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