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Surgery vs Non-Surgical Treatment for Rotator Cuff Tears (ARC Trial)
N/A
Waitlist Available
Led By Nitin Jain, MD,MSPH
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Shoulder pain and/or loss of range of active motion, strength or function
Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification
Must not have
Previous rotator cuff surgery on affected side
Isolated subscapularis &/or teres minor tear on affected side
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study participants will be followed for 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is investigating whether operative or non-operative treatment is better for rotator cuff tears.
Who is the study for?
This trial is for people aged 40 to under 85 with shoulder pain or limited movement due to a small rotator cuff tear, confirmed by MRI. They must be medically fit for surgery (ASA I-III) and able to consent. It's not for those with other primary diagnoses, severe trauma-caused tears, previous surgeries on the affected side, certain muscle-only tears, or contraindications to MRI.
What is being tested?
The study compares two approaches for treating rotator cuff tears: surgical (operative) and non-surgical (non-operative). The goal is to determine which treatment provides better outcomes in terms of pain relief and improved shoulder function.
What are the potential side effects?
Surgical treatment may lead to risks such as infection, bleeding, anesthesia complications, and prolonged recovery time. Non-operative treatments could include physical therapy which generally has minimal side effects but may sometimes cause increased discomfort initially.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have shoulder pain or can't move my shoulder well.
Select...
I am medically fit for surgery according to ASA standards.
Select...
My MRI shows a tear in my shoulder tendon that is 4cm or smaller.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery on my rotator cuff on the affected side before.
Select...
I have a tear in my shoulder's subscapularis or teres minor muscle.
Select...
I have a recent severe shoulder injury.
Select...
My shoulder has severe fatty changes in the rotator cuff tendons.
Select...
I am a candidate for shoulder replacement surgery.
Select...
My main diagnosis is not a rotator cuff tear.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study participants will be followed for 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study participants will be followed for 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Shoulder Pain & Disability Index (SPADI)
Secondary study objectives
American Shoulder and Elbow Surgeons (ASES)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: OperativeActive Control1 Intervention
surgery + post-operative physical therapy
Group II: Non-OperativeActive Control1 Intervention
non-operative physical therapy
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,860 Previous Clinical Trials
6,440,813 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
1,500 Patients Enrolled for Rotator Cuff Tears
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
498 Previous Clinical Trials
1,089,397 Total Patients Enrolled
3 Trials studying Rotator Cuff Tears
2,395 Patients Enrolled for Rotator Cuff Tears
University of Texas Southwestern Medical CenterLead Sponsor
1,086 Previous Clinical Trials
1,058,473 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
1,500 Patients Enrolled for Rotator Cuff Tears
Patient-Centered Outcomes Research InstituteOTHER
576 Previous Clinical Trials
27,079,254 Total Patients Enrolled
Nitin Jain, MD,MSPHPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a shoulder fracture involving the humeral head in the last 2 years.I have had surgery on my rotator cuff on the affected side before.I have a tear in my shoulder's subscapularis or teres minor muscle.I have a recent severe shoulder injury.I use my shoulder to support my body weight.My shoulder has severe fatty changes in the rotator cuff tendons.I am a candidate for shoulder replacement surgery.I am between 40 and 84 years old.I have shoulder pain or can't move my shoulder well.I am medically fit for surgery according to ASA standards.My MRI shows a tear in my shoulder tendon that is 4cm or smaller.My main diagnosis is not a rotator cuff tear.I am between 40 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Operative
- Group 2: Non-Operative
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.
Rotator Cuff Tears Patient Testimony for trial: Trial Name: NCT03295994 — N/A