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

Primary Objective

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 (measured by SPADI) in operative versus non-operative treatments for atraumatic rotator cuff tears.

Is This Study For You?

Let's Get Started!

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 ≥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)
Locations

Boulder Sports Clinic
University of Colorado Hospital

Principal Investigator
Photograph of Eric Mccarty

Eric Mccarty

Study ID

Protocol Number: 17-0628

More information available at ClinicalTrials.gov: NCT03295994

Is this Study for You?

Let's Get Started!

Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers