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

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study participants will be followed for 12 months

Awards & highlights

ARC Trial 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.Check my eligibility

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.See study design

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.

ARC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am medically fit for surgery according to ASA standards.

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My MRI shows a tear in my shoulder tendon that is 4cm or smaller.

ARC Trial 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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Shoulder Pain & Disability Index (SPADI)

Secondary outcome measures

American Shoulder and Elbow Surgeons (ASES)

ARC 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

484 Previous Clinical Trials

1,086,827 Total Patients Enrolled

3 Trials studying Rotator Cuff Tears

2,395 Patients Enrolled for Rotator Cuff Tears

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,631 Total Patients Enrolled

1 Trials studying Rotator Cuff Tears

1,500 Patients Enrolled for Rotator Cuff Tears

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,997,268 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I qualify to take part in this exploration?

"This medical trial requires 120 participants aged 40 to 84 years of age, who exhibit shoulder pain and/or a lack of range in active motion, strength or function. These individuals should have rotator cuff tears as well."

Answered by AI

How many medical facilities are administering this experiment?

"This research project is being conducted at Orthopedic Institute in Sioux Falls, Beth Israel Deaconess Medical Center in Boston and Boston Medical Center in Saint Louis as well as nineteen other medical centres."

Answered by AI

Are any individuals currently eligible to participate in the clinical trial?

"This trial, which was initially published on the 19th of March 2018 and last updated on the 10th of May 2022 is not currently recruiting. However, other medical studies are actively enrolling participants at this moment in time - a total of 105 trials to be exact."

Answered by AI

Is the current research endeavor accepting participants aged 55 and above?

"This clinical trial will only accept 40 to 84 year old participants. There are 10 studies for those under 18 and 94 for seniors above 65 years of age."

Answered by AI

Who else is applying?

What state do they live in?

Tennessee

California

What site did they apply to?

Johns Hopkins

Vanderbilt University Medical Center

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

i have 4 active tears in my left rotator cuff and 2 previous surgeries. i have 3 tears in my rotator cuff. i am not under doctors care and i have limited use/range of motion in my shoulder..

PatientReceived 2+ prior treatments