Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears (NCT03295994) | Clinical Trial Compass
CompletedNot Applicable
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
United States187 participantsStarted 2018-03-19
Plain-language 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.
Who can participate
Age range40 Years – 84 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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)
What they're measuring
1
Shoulder Pain & Disability Index (SPADI)
Timeframe: Study participants will be followed for 12 months