Status:
COMPLETED
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
40-84 years
Phase:
NA
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 ope...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT03295994
Start Date
March 19 2018
End Date
February 28 2025
Last Update
March 30 2025
Active Locations (19)
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1
University of California - San Francisco (UCSF)
San Francisco, California, United States, 94158
2
Western Orthopaedics
Denver, Colorado, United States, 80218
3
University of Colorado - Denver
Denver, Colorado, United States, 80222
4
University of Iowa
Iowa City, Iowa, United States, 52242