<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/NCT03021733</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00056320</org_study_id>
    <nct_id>NCT03021733</nct_id>
  </id_info>
  <brief_title>A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears</brief_title>
  <official_title>A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will involve planning and implementing a two-arm prospective pragmatic cohort&#xD;
      clinical trial in patients with known rotator cuff tears.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project will involve planning and implementing a two-arm prospective pragmatic cohort&#xD;
      clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical&#xD;
      trials reflect real world settings and thus have greater external generalizability than&#xD;
      efficacy trials. The evaluation component in this trial will be three-fold: first, the study&#xD;
      team will compare the success of patients undergoing operative versus non-operative&#xD;
      management and identify which variables predict success in each group; second, investigators&#xD;
      will attempt to predict which patients end up choosing, along with their care giver(s),&#xD;
      operative versus non-operative management by examining the predictive capability of a&#xD;
      selection of variables; third, investigators will evaluate the clinical research site(s),&#xD;
      personnel, and implementation processes for their capability to implement clinical trials&#xD;
      with the intent of planning for a future large multi-site clinical trial building on the&#xD;
      results of the present study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Veterans Rand VR-12 Quality of Life Score</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Veterans Rand VR-12 Quality of Life Score</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Veterans Rand VR-12 Quality of Life Score</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Veterans Rand VR-12 Quality of Life Score</measure>
    <time_frame>16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Veterans Rand VR-12 Quality of Life Score</measure>
    <time_frame>32 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Veterans Rand VR-12 Quality of Life Score</measure>
    <time_frame>48 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Veterans Rand VR-12 Quality of Life Score</measure>
    <time_frame>64 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">222</enrollment>
  <condition>Full Thickness Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>Non-operative</arm_group_label>
    <description>Patients whom elected non-operative treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Operative</arm_group_label>
    <description>Patients whom elected operative treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Operative management</intervention_name>
    <description>Rotator cuff surgery</description>
    <arm_group_label>Operative</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to an orthopaedic clinic with full-thickness rotator cuff tears as&#xD;
        determined by surgeon opinion and imaging&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age with full-thickness rotator cuff tears eligible for&#xD;
             operative repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 years old,&#xD;
&#xD;
          -  non-operative rotator cuff tears,&#xD;
&#xD;
          -  calcific tendonitis, fracture, adhesive capsulitis,&#xD;
&#xD;
          -  severe osteoarthritis of the shoulder,&#xD;
&#xD;
          -  no prior shoulder surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Joel Gagnier</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </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>
    <ipd_description>No individual patient data will be shared</ipd_description>
  </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/NCT03021733
org study id: HUM00056320
nct id: NCT03021733
lead sponsor: 
has dmc: No
This project will involve planning and implementing a two-arm prospective pragmatic cohort
      clinical trial in patients with known rotator cuff tears.
This project will involve planning and implementing a two-arm prospective pragmatic cohort
      clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical
      trials reflect real world settings and thus have greater external generalizability than
      efficacy trials. The evaluation component in this trial will be three-fold: first, the study
      team will compare the success of patients undergoing operative versus non-operative
      management and identify which variables predict success in each group; second, investigators
      will attempt to predict which patients end up choosing, along with their care giver(s),
      operative versus non-operative management by examining the predictive capability of a
      selection of variables; third, investigators will evaluate the clinical research site(s),
      personnel, and implementation processes for their capability to implement clinical trials
      with the intent of planning for a future large multi-site clinical trial building on the
      results of the present study.
observational model: Cohort
time perspective: Prospective
measure: Veterans Rand VR-12 Quality of Life Score
time frame: baseline
measure: Veterans Rand VR-12 Quality of Life Score
time frame: 4 weeks
measure: Veterans Rand VR-12 Quality of Life Score
time frame: 8 weeks
measure: Veterans Rand VR-12 Quality of Life Score
time frame: 16 weeks
measure: Veterans Rand VR-12 Quality of Life Score
time frame: 32 weeks
measure: Veterans Rand VR-12 Quality of Life Score
time frame: 48 weeks
measure: Veterans Rand VR-12 Quality of Life Score
time frame: 64 weeks
arm group label: Non-operative
description: Patients whom elected non-operative treatment
arm group label: Operative
description: Patients whom elected operative treatment
intervention type: Procedure
intervention name: Operative management
description: Rotator cuff surgery
arm group label: Operative
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Joel Gagnier
investigator title: Assistant Professor
mesh term: Rotator Cuff Injuries
sharing ipd: No
ipd description: No individual patient data will be shared