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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)

Detailed Eligibility: 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)

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

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

ClinicalTrials.gov: NCT03295994

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