<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03295994</url>
  </required_header>
  <id_info>
    <org_study_id>171863</org_study_id>
    <secondary_id>1605-35413</secondary_id>
    <secondary_id>5U34AR069201-02</secondary_id>
    <nct_id>NCT03295994</nct_id>
  </id_info>
  <brief_title>Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears</brief_title>
  <acronym>ARC</acronym>
  <official_title>Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the&#xD;
      United States and one of the fastest growing ambulatory surgery procedures. However, data on&#xD;
      comparison of operative versus non-operative treatment is lacking and urgently needed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is non-blinded, randomized controlled trial. Patients will be randomly assigned to&#xD;
      either an operative or non-operative course of treatment and will be followed for 12 months&#xD;
      from baseline.&#xD;
&#xD;
      Aim 1: To compare pain and function in patients undergoing operative versus non-operative&#xD;
      treatment of atraumatic rotator cuff tears at 12 months of follow-up&#xD;
&#xD;
      Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of&#xD;
      operative versus non-operative treatments for atraumatic rotator cuff tears&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 19, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder Pain &amp; Disability Index (SPADI)</measure>
    <time_frame>Study participants will be followed for 12 months</time_frame>
    <description>SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons (ASES)</measure>
    <time_frame>Study participants will be followed for 12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>Operative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>surgery + post-operative physical therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Operative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>non-operative physical therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Operative</intervention_name>
    <description>Arthroscopic rotator cuff surgery followed by physical therapy.</description>
    <arm_group_label>Operative</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-Operative</intervention_name>
    <description>Physical therapy (without surgery).</description>
    <arm_group_label>Non-Operative</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged =&gt;40 years to &lt;85 years&#xD;
&#xD;
          -  Shoulder pain and/or loss of range of active motion, strength or function&#xD;
&#xD;
          -  MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of&#xD;
             4cm or less in longitudinal dimension&#xD;
&#xD;
          -  Medically fit for surgery, defined as Category I-III per American Society of&#xD;
             Anesthesiologists (ASA) Physical Status Classification&#xD;
&#xD;
          -  Ability and willingness to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary diagnosis is something other than a rotator cuff tear&#xD;
&#xD;
          -  History (in last 2 years) of shoulder fracture involving the humeral head on affected&#xD;
             side&#xD;
&#xD;
          -  Previous rotator cuff surgery on affected side&#xD;
&#xD;
          -  Isolated subscapularis &amp;/or teres minor tear on affected side&#xD;
&#xD;
          -  Acute rotator cuff tear caused by a severe trauma&#xD;
&#xD;
          -  Shoulder used as a weight-bearing joint&#xD;
&#xD;
          -  Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)&#xD;
&#xD;
          -  Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD&#xD;
&#xD;
          -  Grade 4 fatty infiltration of rotator cuff (any tendons)&#xD;
&#xD;
          -  Candidate for shoulder arthroplasty at baseline&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nitin Jain, MD,MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hemangi Dhole, MPH</last_name>
    <phone>2146450059</phone>
    <email>hemangi.dhole@utsouthwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Newman, PhD</last_name>
    <phone>2146486736</phone>
    <email>mark.newman@UTSouthwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California - San Francisco (UCSF)</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jocelyn Carpio</last_name>
      <phone>415-502-7389</phone>
      <email>jocelyn.carpio@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>C. Benjamin Ma, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Western Orthopaedics</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Libby Mauter</last_name>
      <phone>303-321-1333</phone>
      <email>LMauter@Western-Ortho.com</email>
    </contact>
    <contact_backup>
      <last_name>Mallory Boyd</last_name>
      <phone>303-321-1333</phone>
      <phone_ext>7423</phone_ext>
      <email>MBoyd@western-ortho.com</email>
    </contact_backup>
    <investigator>
      <last_name>Armand Hatzidakis, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado - Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80222</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andres Barandiaran</last_name>
      <phone>303-724-3917</phone>
      <email>andres.barandiaran@cuanschutz.edu</email>
    </contact>
    <investigator>
      <last_name>Eric McCarty, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arman Kishan</last_name>
      <email>akishan1@jh.edu</email>
    </contact>
    <investigator>
      <last_name>Uma Srikumaran, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jayson Saleet</last_name>
      <email>jsaleet@bu.edu</email>
    </contact>
    <investigator>
      <last_name>Xinning Li, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katiri Wagner-Nunes, CCRC</last_name>
      <phone>617-975-7577</phone>
      <email>kwagner@bidmc.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Joseph DeAngelis, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ryan Mills</last_name>
      <phone>734-615-0768</phone>
      <email>millsrya@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Bruce S. Miller, MD, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Braun, MA</last_name>
      <phone>314-362-3768</phone>
      <email>haasa@wudosis.wustl.edu</email>
    </contact>
    <contact_backup>
      <last_name>Wendy Holloway</last_name>
      <phone>314-747-2492</phone>
      <email>hollowayw@wudosis.wustl.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Matthew V. Smith, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Keller</last_name>
      <phone>614-293-2410</phone>
      <email>michael.keller@osumc.edu</email>
    </contact>
    <investigator>
      <last_name>Gregory Cvetanovich, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rothman Orthopaedic Institute</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Mock, CCRC</last_name>
      <phone>843-876-2211</phone>
      <email>mockl@musc.edu</email>
    </contact>
    <investigator>
      <last_name>Josef K Eichinger, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Orthopedic Institute</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Khris Loe</last_name>
      <phone>888-331-5890</phone>
      <email>kloe@ortho-i.com</email>
    </contact>
    <investigator>
      <last_name>Keith M Baumgarten, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ortho Tennessee - Knoxville Orthopedic Clinic</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grayson Poff</last_name>
      <phone>615-772-8819</phone>
      <email>grayson.poff@orthotennessee.com</email>
    </contact>
    <investigator>
      <last_name>Edwin E. Spencer, Jr., MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Flora Suazo</last_name>
      <phone>615-936-8946</phone>
      <email>flora.m.suazo@vumc.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hemangi Dhole, MPH</last_name>
      <phone>214-645-0059</phone>
      <email>hemangi.dhole@utsouthwestern.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mark Newman, PhD</last_name>
      <phone>214-648-6736</phone>
      <email>mark.newman@UTSouthwestern.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Nitin B. Jain, MD, MSPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ortho Virginia</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul Werth</last_name>
      <email>Paul.Werth@orthovirginia.com</email>
    </contact>
    <investigator>
      <last_name>Andrew Neviaser, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://shoulderstudy.org/studies/arc-trial/</url>
    <description>ARC Trial website</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Nitin Jain</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>arthroscopy</keyword>
  <keyword>physical therapy</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>surgery</keyword>
  <keyword>rotator cuff tear</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03295994
org study id: 171863
secondary id: 1605-35413
secondary id: 5U34AR069201-02
nct id: NCT03295994
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Shoulder Pain & Disability Index (SPADI)
time frame: Study participants will be followed for 12 months
description: SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst.
measure: American Shoulder and Elbow Surgeons (ASES)
time frame: Study participants will be followed for 12 months
description: 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.
arm group label: Operative
arm group type: Active Comparator
description: surgery + post-operative physical therapy
arm group label: Non-Operative
arm group type: Active Comparator
description: non-operative physical therapy
intervention type: Procedure
intervention name: Operative
description: Arthroscopic rotator cuff surgery followed by physical therapy.
arm group label: Operative
intervention type: Procedure
intervention name: Non-Operative
description: Physical therapy (without surgery).
arm group label: Non-Operative
criteria: 
gender: All
minimum age: 40 Years
maximum age: 84 Years
healthy volunteers: No
last name: Nitin Jain, MD,MSPH
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
last name: Hemangi Dhole, MPH
phone: 2146450059
email: hemangi.dhole@utsouthwestern.edu
last name: Mark Newman, PhD
phone: 2146486736
email: mark.newman@UTSouthwestern.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://shoulderstudy.org/studies/arc-trial/
description: ARC Trial website
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Nitin Jain
investigator title: Professor
mesh term: Rotator Cuff Injuries
sharing ipd: No