Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
ARC
3 other identifiers
interventional
187
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2017
CompletedFirst Posted
Study publicly available on registry
September 28, 2017
CompletedStudy Start
First participant enrolled
March 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedMarch 30, 2026
March 1, 2026
7 years
September 22, 2017
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Shoulder Pain & Disability Index (SPADI)
SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.
Study participants will be followed for 12 months
Secondary Outcomes (1)
American Shoulder and Elbow Surgeons (ASES)
Study participants will be followed for 12 months
Study Arms (2)
Operative
ACTIVE COMPARATORsurgery + post-operative physical therapy
Non-Operative
ACTIVE COMPARATORnon-operative physical therapy
Interventions
Eligibility Criteria
You may qualify if:
- Aged =\>40 years to \<85 years
- 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
You may not qualify if:
- Primary diagnosis is something other than a rotator cuff tear
- 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
- Severe problems with maintaining follow-up expected (such as, but not limited to, history of substance abuse, homelessness/incarceration, dementia, brain injury, and psychotic disorders)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of California - San Francisco (UCSF)
San Francisco, California, 94158, United States
Western Orthopaedics
Denver, Colorado, 80218, United States
University of Colorado - Denver
Denver, Colorado, 80222, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Johns Hopkins
Baltimore, Maryland, 21218, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48106, United States
Washington University
St Louis, Missouri, 63110, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43202, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Orthopedic Institute
Sioux Falls, South Dakota, 57105, United States
Ortho Tennessee - Knoxville Orthopedic Clinic
Knoxville, Tennessee, 37922, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Ortho Virginia
Richmond, Virginia, 23294, United States
Related Publications (1)
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.
PMID: 31397866DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nitin B Jain, MD,MSPH
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Physical Medicine & Rehabilitation, and Orthopaedics
Study Record Dates
First Submitted
September 22, 2017
First Posted
September 28, 2017
Study Start
March 19, 2018
Primary Completion
February 28, 2025
Study Completion
February 28, 2025
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share