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CompletedNCT03295994ARCUpdated Mar 30, 2026

Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

An interventional study of Arthroscopic Rotator Cuff Surgery and Physical Therapy in Rotator Cuff Tear, sponsored by University of Michigan. Completed at 19 sites in United States. Open to participants aged 40 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
187
Allocation
Randomized
Ages
40 Years to 84 Years
Sex
All
01

Study 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.

Read the detailed description

This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline.

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.

02

Conditions studied

  • Rotator Cuff Tear

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Keywords

  • arthroscopy
  • physical therapy
  • rehabilitation
  • surgery
  • rotator cuff tear
03

Who can participate

Ages eligible
40 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
187 participants (actual)

Study arms

  • Active comparator
    Operative

    surgery + post-operative physical therapy

    Procedure: Arthroscopic Rotator Cuff Surgery · Procedure: Physical Therapy

  • Active comparator
    Non-Operative

    non-operative physical therapy

    Procedure: Physical Therapy

Interventions

  • ProcedureArthroscopic Rotator Cuff Surgery

    Arthroscopic rotator cuff surgery

  • ProcedurePhysical Therapy

    Physical therapy

05

What researchers measure

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.

    Time frame: Study participants will be followed for 12 months

Secondary outcomes

  1. American Shoulder and Elbow Surgeons (ASES)

    ASES is a pain and activity of daily living questionnaire. The range is from 0 to 100, with 0 being worst, and 100 being best.

    Time frame: Study participants will be followed for 12 months

06

Study locations

19 sites
  • 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
07

References and documents

Publications

  • 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. PubMed 31397866 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03295994
Lead sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Responsible party
Nitin Jain (Professor of Physical Medicine & Rehabilitation, and Orthopaedics, University of Michigan) — Principal investigator
First posted
Sep 28, 2017
Start date
Mar 19, 2018
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
Mar 30, 2026

Study contacts

Nitin B Jain, MD,MSPH
principal investigator · University of Michigan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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