<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/NCT03809520</url>
  </required_header>
  <id_info>
    <org_study_id>201612747</org_study_id>
    <nct_id>NCT03809520</nct_id>
  </id_info>
  <brief_title>An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA</brief_title>
  <official_title>An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>J L Marsh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orthopaedic Trauma Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The immediate goal of the proposed research is to test the value of a new low-cost, low-dose&#xD;
      standing CT system for efficient early detection of both joint degeneration and elevated&#xD;
      contact stress. The standing CT scanner holds promise for detecting arthritic changes earlier&#xD;
      than other imaging modalities because of the combination of its 3D nature and ability to&#xD;
      image joints in a weight-bearing pose. A secondary goal of the proposed research is to enable&#xD;
      predictive models for osteoarthritis risk based on measures of post treatment contact stress,&#xD;
      both to inform treatment and so that new interventions can be tested in a manner&#xD;
      incorporating risk stratification.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals who present with an intra-articular of the tibial plafond will be consented to&#xD;
      participate in this study. We will obtain pedCAT scans at 6, 12, and 18 months post-injury,&#xD;
      as well as several questionnaires that will be administered during the clinical visits. We&#xD;
      will also review the subjects' electronic medical record for data related to the injury,&#xD;
      including the timing and mechanism of injury, time from injury to surgery, length of hospital&#xD;
      stay, any complications and/or subsequent ankle surgeries, as well as any clinic notes,&#xD;
      imaging, and/or outcomes scores related to the calcaneus fracture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the ankle joint space width</measure>
    <time_frame>18 months</time_frame>
    <description>Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging compared to baseline pedCAT imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ankle pain</measure>
    <time_frame>18 months</time_frame>
    <description>Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ankle function</measure>
    <time_frame>18 months</time_frame>
    <description>Subjective measure of foot and ankle function gathered by patient reported outcomes questionnaires</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Orthopedic Disorder</condition>
  <condition>Trauma</condition>
  <condition>Ankle Fractures</condition>
  <condition>Post-traumatic Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Experimental: pedCAT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>pedCAT</intervention_name>
    <description>Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.</description>
    <arm_group_label>Experimental: pedCAT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals 18 to 70 years old Sustained an intra-articular fracture of the tibial&#xD;
             plafond Indicated for operative treatment Present for treatment within 4 weeks of&#xD;
             injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or planning on becoming pregnant Individuals younger than 18&#xD;
             and older than 70&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J L Marsh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Catherine Fruehling, BA</last_name>
    <phone>3194678256</phone>
    <email>catherine-fruehling@uiowa.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Fruehling, BA</last_name>
      <phone>319-467-8256</phone>
      <email>catherine-fruehling@uiowa.edu</email>
    </contact>
    <investigator>
      <last_name>J L Marsh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>J L Marsh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Ankle Fractures</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/NCT03809520
org study id: 201612747
nct id: NCT03809520
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The immediate goal of the proposed research is to test the value of a new low-cost, low-dose
      standing CT system for efficient early detection of both joint degeneration and elevated
      contact stress. The standing CT scanner holds promise for detecting arthritic changes earlier
      than other imaging modalities because of the combination of its 3D nature and ability to
      image joints in a weight-bearing pose. A secondary goal of the proposed research is to enable
      predictive models for osteoarthritis risk based on measures of post treatment contact stress,
      both to inform treatment and so that new interventions can be tested in a manner
      incorporating risk stratification.
Individuals who present with an intra-articular of the tibial plafond will be consented to
      participate in this study. We will obtain pedCAT scans at 6, 12, and 18 months post-injury,
      as well as several questionnaires that will be administered during the clinical visits. We
      will also review the subjects' electronic medical record for data related to the injury,
      including the timing and mechanism of injury, time from injury to surgery, length of hospital
      stay, any complications and/or subsequent ankle surgeries, as well as any clinic notes,
      imaging, and/or outcomes scores related to the calcaneus fracture.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in the ankle joint space width
time frame: 18 months
description: Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging compared to baseline pedCAT imaging
measure: Change in ankle pain
time frame: 18 months
description: Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaires
measure: Change in ankle function
time frame: 18 months
description: Subjective measure of foot and ankle function gathered by patient reported outcomes questionnaires
arm group label: Experimental: pedCAT
arm group type: Experimental
description: Subjects in this group will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury.
intervention type: Radiation
intervention name: pedCAT
description: Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
arm group label: Experimental: pedCAT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: J L Marsh, MD
role: Principal Investigator
affiliation: University of Iowa
last name: Catherine Fruehling, BA
phone: 3194678256
email: catherine-fruehling@uiowa.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: J L Marsh
investigator title: Professor
mesh term: Musculoskeletal Diseases
mesh term: Ankle Fractures
sharing ipd: No