<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/NCT03018210</url>
  </required_header>
  <id_info>
    <org_study_id>IMPROVE_2017</org_study_id>
    <nct_id>NCT03018210</nct_id>
  </id_info>
  <brief_title>The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff</brief_title>
  <acronym>IMPROVE</acronym>
  <official_title>The Impact of Psychological Factors on the Outcome of Surgical Repair for Rotator Cuff Tears: a Prospective Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will be a multi-centre, prospective, observational cohort to determine if&#xD;
      psychological well-being has an impact on the outcome of surgical repair for rotator cuff&#xD;
      tears.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will take place at multiple centres across the University of Toronto network.&#xD;
&#xD;
      The primary outcome of interest will be the Western Ontario Rotator Cuff Index (WORC)&#xD;
      measured at one year following surgery. The WORC is a disease specific, quality of life&#xD;
      measurement tool with 21 questions separated into 5 domains: physical symptoms,&#xD;
      sports/recreation, work, lifestyle, and emotion. Secondary outcomes of interest will be the&#xD;
      Constant Murley Score (CMS), which relies on subjective as well as objective components of&#xD;
      scoring, and the EQ-5D-5L which will be used as a general measure of health.&#xD;
&#xD;
      Psychological well-being will be measured using the Patient Health Questionnaire-8 (PHQ-8),&#xD;
      the 7-item General Anxiety Disorder scale (GAD-7), the Patient Catastrophizing Scale (PCS) ,&#xD;
      and the expectations survey from the Musculoskeletal Outcomes Data Evaluation and Management&#xD;
      System [MODEMS] . Post-operative satisfaction will be measured using the MODEMS satisfaction&#xD;
      survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Western Ontario Rotator Cuff Index (WORC)</measure>
    <time_frame>1 year following surgery</time_frame>
    <description>The WORC is a disease specific, quality of life measurement tool with 21 questions separated into 5 domains: physical symptoms, sports/recreation, work, lifestyle, and emotion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Constant Murley Score</measure>
    <time_frame>1 year following surgery</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">267</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical repair of the rotator cuff</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with rotator cuff tears confirmed by Magnetic Resonance Imagining (MRI) findings&#xD;
        presenting to the out-patient clinic, examined by the treating surgeon for the clinical&#xD;
        need for surgical repair.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females aged 35-80&#xD;
&#xD;
          -  Symptomatic, full-thickness tear of the rotator cuff, confirmed by MRI examination&#xD;
&#xD;
          -  Patients undergoing rotator cuff repair&#xD;
&#xD;
          -  Symptoms must have been present for 3 or more months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing subacromial decompression alone&#xD;
&#xD;
          -  Glenohumeral arthritis of Grade 2 or higher&#xD;
&#xD;
          -  Patients undergoing revision surgery&#xD;
&#xD;
          -  Patients receiving Workplace Safety and Insurance Board (WSIB) benefits&#xD;
&#xD;
          -  Neurologic disorder affecting the upper extremity&#xD;
&#xD;
          -  Injury to the rotator cuff sustained as a result of polytrauma, or any other&#xD;
             significant injuries sustained that the treating surgeon believes will have an effect&#xD;
             on the recovery from rotator cuff repair surgery&#xD;
&#xD;
          -  Patients involved in a legal case/proceedings or seeking legal advice related to the&#xD;
             injury sustained to the rotator cuff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Nauth, MD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Milena Vicente, RN</last_name>
    <phone>416-864-6060</phone>
    <phone_ext>2608</phone_ext>
    <email>vicentem@smh.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christine Schemitsch, BSc</last_name>
    <phone>416-864-6060</phone>
    <phone_ext>2608</phone_ext>
    <email>schemitschc@smh.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Theodoropoulos, MD, FRCSC</last_name>
    </contact>
    <investigator>
      <last_name>John Theodoropoulos, MD, FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Henry, MD, FRCSC</last_name>
    </contact>
    <investigator>
      <last_name>Patrick Henry, MD, FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christian Veillette, MD, FRCSC</last_name>
    </contact>
    <investigator>
      <last_name>Christian Veillette, MD, FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Women's College Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jas Chahal, MD, FRCSC</last_name>
    </contact>
    <investigator>
      <last_name>Jas Chahal, MD, FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Timothy Dwyer, MD, FRCSC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <zip>M5C 1R6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Milena Vicente, RN</last_name>
      <phone>416-864-6060</phone>
      <phone_ext>2608</phone_ext>
      <email>vicentem@smh.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>June 16, 2021</last_update_submitted>
  <last_update_submitted_qc>June 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03018210
org study id: IMPROVE_2017
nct id: NCT03018210
lead sponsor: 
has dmc: No
The proposed study will be a multi-centre, prospective, observational cohort to determine if
      psychological well-being has an impact on the outcome of surgical repair for rotator cuff
      tears.
This study will take place at multiple centres across the University of Toronto network.

      The primary outcome of interest will be the Western Ontario Rotator Cuff Index (WORC)
      measured at one year following surgery. The WORC is a disease specific, quality of life
      measurement tool with 21 questions separated into 5 domains: physical symptoms,
      sports/recreation, work, lifestyle, and emotion. Secondary outcomes of interest will be the
      Constant Murley Score (CMS), which relies on subjective as well as objective components of
      scoring, and the EQ-5D-5L which will be used as a general measure of health.

      Psychological well-being will be measured using the Patient Health Questionnaire-8 (PHQ-8),
      the 7-item General Anxiety Disorder scale (GAD-7), the Patient Catastrophizing Scale (PCS) ,
      and the expectations survey from the Musculoskeletal Outcomes Data Evaluation and Management
      System [MODEMS] . Post-operative satisfaction will be measured using the MODEMS satisfaction
      survey.
observational model: Cohort
time perspective: Prospective
measure: Western Ontario Rotator Cuff Index (WORC)
time frame: 1 year following surgery
description: The WORC is a disease specific, quality of life measurement tool with 21 questions separated into 5 domains: physical symptoms, sports/recreation, work, lifestyle, and emotion.
measure: Constant Murley Score
time frame: 1 year following surgery
intervention type: Procedure
intervention name: Surgical repair of the rotator cuff
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
last name: Aaron Nauth, MD, FRCSC
role: Principal Investigator
affiliation: Unity Health Toronto
last name: Milena Vicente, RN
phone: 416-864-6060
phone ext: 2608
email: vicentem@smh.ca
last name: Christine Schemitsch, BSc
phone: 416-864-6060
phone ext: 2608
email: schemitschc@smh.ca
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries
sharing ipd: No