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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295994
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : April 27, 2023
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Nitin Jain, University of Texas Southwestern Medical Center

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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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).


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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: Hemangi Dhole, MPH 2146450059 hemangi.dhole@utsouthwestern.edu
Contact: Mark Newman, PhD 2146486736 mark.newman@UTSouthwestern.edu

Locations
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Sponsors and Collaborators
University of Texas Southwestern 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 University of Texas Southwestern Medical Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nitin Jain, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03295994    
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: April 27, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Texas Southwestern 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