Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
NCT ID: NCT03295994
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
189 participants
INTERVENTIONAL
2018-03-19
2025-02-28
Brief Summary
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Detailed Description
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Aim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up
Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears
5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Operative
surgery + post-operative physical therapy
Operative
Arthroscopic rotator cuff surgery followed by physical therapy.
Non-Operative
non-operative physical therapy
Non-Operative
Physical therapy (without surgery).
Interventions
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Operative
Arthroscopic rotator cuff surgery followed by physical therapy.
Non-Operative
Physical therapy (without surgery).
Eligibility Criteria
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Inclusion Criteria
* Shoulder pain and/or loss of range of active motion, strength or function
* MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension
* Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification
* Ability and willingness to provide informed consent
Exclusion Criteria
* History (in last 2 years) of shoulder fracture involving the humeral head on affected side
* Previous rotator cuff surgery on affected side
* Isolated subscapularis \&/or teres minor tear on affected side
* Acute rotator cuff tear caused by a severe trauma
* Shoulder used as a weight-bearing joint
* Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)
* Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD
* Grade 4 fatty infiltration of rotator cuff (any tendons)
* Candidate for shoulder arthroplasty at baseline
* Non-English speaking
40 Years
84 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Michigan
OTHER
Responsible Party
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Nitin Jain
Professor of Physical Medicine & Rehabilitation, and Orthopaedics
Principal Investigators
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Nitin Jain, MD,MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of California - San Francisco (UCSF)
San Francisco, California, United States
Western Orthopaedics
Denver, Colorado, United States
University of Colorado - Denver
Denver, Colorado, United States
University of Iowa
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Orthopedic Institute
Sioux Falls, South Dakota, United States
Ortho Tennessee - Knoxville Orthopedic Clinic
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Ortho Virginia
Richmond, Virginia, United States
Countries
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References
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Jain NB, Ayers GD, Koudelkova H, Archer KR, Dickinson R, Richardson B, Derryberry M, Kuhn JE; ARC Trial Group. Operative vs Nonoperative Treatment for Atraumatic Rotator Cuff Tears: A Trial Protocol for the Arthroscopic Rotator Cuff Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199050. doi: 10.1001/jamanetworkopen.2019.9050.
Related Links
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ARC Trial website
Other Identifiers
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1605-35413
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
171863
Identifier Type: -
Identifier Source: org_study_id
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