Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:50 - 84
Updated:11/8/2018
Start Date:March 19, 2018
End Date:December 30, 2022
Contact:Helen M Koudelkova, MA
Email:helen.koudelkova@vumc.org
Phone:615-936-8343

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Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial

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.

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

Inclusion Criteria:

- Aged =>50 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

- Grade 4 fatty infiltration of rotator cuff (any tendons)

- Candidate for shoulder arthroplasty at baseline

- Non-English speaking
We found this trial at
12
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: John D. Kelly, IV, MD
Phone: 215-294-9169
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Brian R Wolf, MD, MS
Phone: 319-467-8316
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-936-8434
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Bruce S. Miller, MD, MS
Phone: 734-615-1297
University of Michigan The University of Michigan was founded in 1817 as one of the...
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Andrew Nevaiser, MD
Phone: 614-366-0912
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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Dallas, Texas 75390
Principal Investigator: Michael Khazzam, MD
Phone: 214-645-0421
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Dallas, TX
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Denver, Colorado 80291
Principal Investigator: Eric McCarty, MD
Phone: 720-848-8228
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Denver, CO
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260 Fort Sanders West Boulevard
Knoxville, Tennessee 37922
Principal Investigator: Edwin E. Spencer, Jr., MD
Phone: 731-336-1607
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Knoxville, TN
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Carolyn Hettrich, MD, MPH
Phone: 859-218-0839
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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Saint Louis, Missouri 63110
Principal Investigator: Matthew V. Smith, MD, MSc
Phone: 314-362-3768
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Saint Louis, MO
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500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
Principal Investigator: C. Benjamin Ma, MD
Phone: 415-502-7389
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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San Francisco, CA
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Sioux Falls, South Dakota 57105
Principal Investigator: Keith M Baumgarten, MD
Phone: 888-331-5890
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Sioux Falls, SD
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