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Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears (ARC)

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ClinicalTrials.gov Identifier: NCT03295994
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : November 6, 2018
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Nitin Jain, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Procedure: Operative Procedure: Non-Operative Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Active Comparator: Operative
surgery + post-operative physical therapy
Procedure: Operative
Arthroscopic rotator cuff surgery followed by physical therapy.

Active Comparator: Non-Operative
non-operative physical therapy
Procedure: Non-Operative
Physical therapy (without surgery).




Primary Outcome Measures :
  1. Shoulder Pain & Disability Index (SPADI) [ Time Frame: 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 :
  1. American Shoulder and Elbow Surgeons (ASES) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295994


Contacts
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Contact: Helen M Koudelkova, MA 615-936-8343 helen.koudelkova@vumc.org

Locations
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United States, California
University of California - San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94158
Contact: Jocelyn Carpio    415-502-7389    jocelyn.carpio@ucsf.edu   
Principal Investigator: C. Benjamin Ma, MD         
United States, Colorado
University of Colorado - Denver Recruiting
Denver, Colorado, United States, 80222
Contact: Jeffery Wilson    720-848-8228    jeffery.wilson@ucdenver.edu   
Principal Investigator: Eric McCarty, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Shannon Ortiz, MPH    319-467-8316    shannon-ortiz@uiowa.edu   
Principal Investigator: Brian R Wolf, MD, MS         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Cale Jacobs, PhD, ATC    859-218-0839    cale.jacobs@uky.edu   
Principal Investigator: Carolyn Hettrich, MD, MPH         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Chris Robbins, PhD, MPA    734-615-1297    crobbins@med.umich.edu   
Principal Investigator: Bruce S. Miller, MD, MS         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Amanda Braun, MA    314-362-3768    haasa@wudosis.wustl.edu   
Contact: Wendy Holloway    314-747-2492    hollowayw@wudosis.wustl.edu   
Principal Investigator: Matthew V. Smith, MD, MSc         
Sub-Investigator: Rick W. Wright, MD         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43202
Contact: Rachel Parker    614-366-0912    rachel.parker@osumc.edu   
Principal Investigator: Andrew Nevaiser, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Beth Howard, MS, ATC    215-294-9169    beth.howard@uphs.upenn.edu   
Principal Investigator: John D. Kelly, IV, MD         
United States, South Dakota
Orthopedic Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Khris Loe    888-331-5890    kloe@ortho-i.com   
Principal Investigator: Keith M Baumgarten, MD         
United States, Tennessee
Ortho Tennessee - Knoxville Orthopedic Clinic Recruiting
Knoxville, Tennessee, United States, 37922
Contact: Robert Sleadd    731-336-1607    robert.sleadd@orthotennessee.com   
Principal Investigator: Edwin E. Spencer, Jr., MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Helen Koudelkova, MA    615-936-8434    helen.koudelkova@vumc.org   
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Chastity Escalante, AS    214-645-0421    chastity.escalante@UTSouthwestern.edu   
Contact: Cynthia Wright    214-645-0423    cynthia.wright@UTSouthwestern.edu   
Principal Investigator: Michael Khazzam, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Patient-Centered Outcomes Research Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Nitin Jain, MD,MSPH Vanderbilt University Medical Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nitin Jain, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03295994     History of Changes
Other Study ID Numbers: 171863
1605-35413 ( Other Grant/Funding Number: PCORI )
5U34AR069201-02 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nitin Jain, Vanderbilt University Medical Center:
arthroscopy
physical therapy
rehabilitation
surgery
rotator cuff tear
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries