Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

Not Applicable

Active, not recruiting

Brief 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.

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Operative	Operative	surgery + post-operative physical therapy
Non-Operative	Non-Operative	non-operative physical therapy

Primary Outcome Measures

Name	Time	Method
Shoulder Pain & Disability Index (SPADI)	Study participants will be followed for 12 months	SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.

Secondary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES)	Study participants will be followed for 12 months	ASES is a pain and activity of daily living questionnaire. The range is from 0 to 100, with 0 being worst, and 100 being best.

Locations (19): Ortho Tennessee - Knoxville Orthopedic Clinic
🇺🇸
Knoxville, Tennessee, United States
Johns Hopkins
🇺🇸
Baltimore, Maryland, United States
Rothman Orthopaedic Institute
🇺🇸
Philadelphia, Pennsylvania, United States
The Ohio State University Wexner Medical Center
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Columbus, Ohio, United States
University of Iowa
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Iowa City, Iowa, United States
Washington University
🇺🇸
Saint Louis, Missouri, United States
University of Kentucky
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Lexington, Kentucky, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Orthopedic Institute
🇺🇸
Sioux Falls, South Dakota, United States
University of Texas Southwestern
🇺🇸
Dallas, Texas, United States
University of California - San Francisco (UCSF)
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San Francisco, California, United States
Medical University of South Carolina
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Charleston, South Carolina, United States
Western Orthopaedics
🇺🇸
Denver, Colorado, United States
University of Michigan
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Ann Arbor, Michigan, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
University of Colorado - Denver
🇺🇸
Denver, Colorado, United States
Boston Medical Center
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Boston, Massachusetts, United States
Ortho Virginia
🇺🇸
Richmond, Virginia, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States