Rotator Cuff Tears > Non-Operative

Surgery vs Non-Surgical Treatment for Rotator Cuff Tears (ARC Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen By Nitin Jain, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Michigan

No Placebo Group

Trial Summary

What is the purpose of this trial?

Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

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.

My shoulder has severe fatty changes in the rotator cuff tendons.

I am a candidate for shoulder replacement surgery.

My main diagnosis is not a rotator cuff tear.

Participant Groups

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.

Group I: Operative Active Control 1 Intervention

surgery + post-operative physical therapy

Group II: Non-Operative Active Control 1 Intervention

non-operative physical therapy

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Vanderbilt University Medical Center Nashville, TN

Ortho Virginia Richmond, VA

University of Pennsylvania Philadelphia, PA

Medical University of South Carolina Charleston, SC

More Trial Locations

Who is running the clinical trial?

University of Michigan Lead Sponsor

University of Texas Southwestern Medical Center Lead Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Collaborator

Patient-Centered Outcomes Research Institute Collaborator

References