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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 Texas Southwestern Medical Center
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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~study participants will be followed for 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and study participants will be followed for 12 months for reporting.

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?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,323 Total Patients Enrolled
3 Trials studying Rotator Cuff Tears
2,395 Patients Enrolled for Rotator Cuff Tears
University of Texas Southwestern Medical CenterLead Sponsor
1,081 Previous Clinical Trials
1,056,169 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
1,500 Patients Enrolled for Rotator Cuff Tears
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,078,943 Total Patients Enrolled

Media Library

Non-Operative Clinical Trial Eligibility Overview. Trial Name: NCT03295994 — N/A
Rotator Cuff Tears Research Study Groups: Operative, Non-Operative
Rotator Cuff Tears Clinical Trial 2023: Non-Operative Highlights & Side Effects. Trial Name: NCT03295994 — N/A
Non-Operative 2023 Treatment Timeline for Medical Study. Trial Name: NCT03295994 — N/A
Rotator Cuff Tears Patient Testimony for trial: Trial Name: NCT03295994 — N/A
~7 spots leftby Feb 2025
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