Surgery vs Non-Surgical Treatment for Rotator Cuff Tears

(ARC Trial)

Recruiting at 20 trial locations

Overseen By Mark Newman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Shoulder fracture, Previous surgery, Osteoarthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

189 Participants Needed

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.

Research Team

Nitin Jain, MD

Principal Investigator

University of Michigan

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

Ability and willingness to provide informed consent

I am between 40 and 84 years old.

I have shoulder pain or can't move my shoulder well.

Exclusion Criteria

Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)

Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD

I had a shoulder fracture involving the humeral head in the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either operative treatment with surgery and post-operative physical therapy or non-operative treatment with physical therapy

12 months

Follow-up

Participants are monitored for pain and function outcomes using SPADI and ASES measures

12 months

Treatment Details

Interventions

• Non-Operative
• Operative

Trial Overview 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.

Participant Groups

Group I: Operative Active Control 1 Intervention

surgery + post-operative physical therapy

Group II: Non-Operative Active Control 1 Intervention

non-operative physical therapy

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

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

Collaborator

Trials

508

Recruited

1,090,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+