Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
Purpose
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.
Condition
- Rotator Cuff Tear
Eligibility
- Eligible Ages
- Between 40 Years and 84 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Operative |
surgery + post-operative physical therapy |
|
|
Active Comparator Non-Operative |
non-operative physical therapy |
|
Recruiting Locations
San Francisco, California 94158
Denver, Colorado 80218
Denver, Colorado 80222
Boston, Massachusetts 02215
Ann Arbor, Michigan 48106
Saint Louis, Missouri 63110
Columbus, Ohio 43202
Charleston, South Carolina 29425
Sioux Falls, South Dakota 57105
Knoxville, Tennessee 37922
Nashville, Tennessee 37232
Dallas, Texas 75390
More Details
- NCT ID
- NCT03295994
- Status
- Recruiting
- Sponsor
- University of Texas Southwestern Medical Center
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 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 of operative versus non-operative treatments for atraumatic rotator cuff tears