Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

Completed · Not applicable

Conditions studied: Rotator Cuff Tear

In brief

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.

Key facts

Study ID

NCT03295994

Run by

University of Michigan

People needed

187

Starts

2018-03-19

Expected to finish

2025-02-28

Last updated by the study team

2026-03-30

Who can join

Age: 40 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• 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
• 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

Full record on ClinicalTrials.gov

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