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Keep this study
Lead
University of Michigan
With
Patient-Centered Outcomes Research Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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.
Age
40–84
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Clareo Health | Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
