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Operative versus Non-operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial V:1.0 3OCT2017

Study category: Bones, Muscles, and Joints

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Description

This is an unblinded, multi-center, pragmatic randomized controlled clinical trial of operative versus non-operative treatments for atraumatic rotator cuff tears. A sample size of 700 patients will be enrolled with approximately equal numbers of patients randomized to operative treatment (surgery + post-op physical therapy) and non-operative treatment (physical therapy only without surgery).

Details
Age

Adult

Eligibility

? Aged &#8805;50 years to <85 years ? Shoulder pain and/or loss 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 (see Table 1: ASA Physical Status Classifications and Examples)

Subject Inclusion Criteria In order to be eligible to participate in this study, an individual must meet all of the following criteria: ? Aged ≥50 years to <85 years ? Shoulder pain and/or loss 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 (see Table 1: ASA Physical Status Classifications and Examples) ? Ability and willingness to provide informed consent Subject Exclusion Criteria Any individual who meets any of the following criteria will be excluded from participation in this study: ? 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 (see TABLE 2: Trauma Classification) ? Shoulder used as a weight-bearing joint ? Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.) ? Glenohumeral osteoarthritis on xrays/MRI ? Grade 4 fatty infiltration of rotator cuff (any tendons) ? Candidate for reverse shoulder arthroplasty or total shoulder arthroplasty at baseline ? Non-English speaking (questionnaires only validated in English) ? 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)

Type of Study

Outcomes Research

Locations

Boulder Sports Clinic
University of Colorado Hospital

Principal Investigator
Eric Mccarty,  MD

Eric Mccarty, MD

Study ID

Protocol Number: 17-0628

More information available at ClinicalTrials.gov: NCT03295994

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