<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/NCT04402502</url>
  </required_header>
  <id_info>
    <org_study_id>5147</org_study_id>
    <nct_id>NCT04402502</nct_id>
  </id_info>
  <brief_title>Dynamic 4DCT to Examine Wrist Carpal Mechanics</brief_title>
  <official_title>Dynamic 4DCT to Examine the Effect of Mal-united Distal Radius Fractures on Carpal Contact Mechanics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</source>
  <oversight_info>
    <has_dmc>No</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>
      Osteoarthritis can develop after an injury like a broken bone. Problems with how the bones&#xD;
      line up can lead to abnormal loading which will destroy the cartilage that covers and&#xD;
      protects the bones. Once this happens, patients experience substantial pain and disability.&#xD;
      Researchers and doctors use planar x-rays to evaluate joints; but these are not always&#xD;
      precise and are limited to two dimensions. Three-dimensional (3D) computed tomography (CT)&#xD;
      can be used to look at the joints of the wrist in three dimensions, but is limited to static&#xD;
      frames. Symptoms arising from joint instability often occur when the wrist is moving and when&#xD;
      it is performing a functional task (opening a jar). Four dimensional computed tomography&#xD;
      (4DCT) can detect dynamics changes in the small structures of the wrist with high temporal&#xD;
      and spatial resolution. This novel imaging techniques provides a movie of bones in the wrist,&#xD;
      in 3D, while in the scanner. In this proposal, the investigator's will use 4DCT and look at&#xD;
      how joint alignment of the distal radius effects the joints in the wrist, and investigate how&#xD;
      it relates to patient's function, description of pain and the presence of Osteoarthritis 10&#xD;
      years following fracture. This imaging will drive safer clinical research and practice and&#xD;
      will develop tools that predict the risk of developing arthritis that will help doctors&#xD;
      determine when surgery is necessary to prevent arthritis of the hand and wrist, and pain and&#xD;
      disability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A series of 60 participants (30 male: 30 female) with current distal radius fractures will be&#xD;
      recruited. Clinical eligibility will include a unilateral DRF treated with closed reduction&#xD;
      and casting. These measures will be assessed at baseline (&lt;6 weeks following injury), 3- 6&#xD;
      months and 12 months following fracture. A second series of 80 participants (40 male: 40&#xD;
      female) who suffered a DRF ≥10 years previously will be recruited and tested. Exclusion&#xD;
      criteria for these two cohorts will include presence of neurological disorders, rheumatoid&#xD;
      arthritis or co-morbid health conditions that preclude completion of study measures. Twenty&#xD;
      additional healthy participants will be recruited.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2018</start_date>
  <completion_date type="Actual">February 2, 2022</completion_date>
  <primary_completion_date type="Actual">September 24, 2021</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>
    <intervention_model_description>Healthy Population</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hand Joint Spacing</measure>
    <time_frame>3 years</time_frame>
    <description>To measure joint spacing of the hand in a 3D ultrasound image</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Healthy Population</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy Individuals with no presence of neurological disorders, rheumatoid arthritis or comorbid health conditions, and are not pregnant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound Imaging</intervention_name>
    <description>The participant will go to the Rheumatology clinic (St. Joseph's Hospital) and have 3D hand ultrasound performed on their hands.</description>
    <arm_group_label>Healthy Population</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fluent in English, capacity to provide consent,&#xD;
&#xD;
          -  over the age of 18 years old, with no previous injury to either hand or wrist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy and presence of neurological disorders, rheumatoid arthritis or comorbid&#xD;
             health conditions that preclude completion of study measures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. Joseph's Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>August 9, 2022</last_update_submitted>
  <last_update_submitted_qc>August 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>3D Ultrasound Monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04402502
org study id: 5147
nct id: NCT04402502
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Osteoarthritis can develop after an injury like a broken bone. Problems with how the bones
      line up can lead to abnormal loading which will destroy the cartilage that covers and
      protects the bones. Once this happens, patients experience substantial pain and disability.
      Researchers and doctors use planar x-rays to evaluate joints; but these are not always
      precise and are limited to two dimensions. Three-dimensional (3D) computed tomography (CT)
      can be used to look at the joints of the wrist in three dimensions, but is limited to static
      frames. Symptoms arising from joint instability often occur when the wrist is moving and when
      it is performing a functional task (opening a jar). Four dimensional computed tomography
      (4DCT) can detect dynamics changes in the small structures of the wrist with high temporal
      and spatial resolution. This novel imaging techniques provides a movie of bones in the wrist,
      in 3D, while in the scanner. In this proposal, the investigator's will use 4DCT and look at
      how joint alignment of the distal radius effects the joints in the wrist, and investigate how
      it relates to patient's function, description of pain and the presence of Osteoarthritis 10
      years following fracture. This imaging will drive safer clinical research and practice and
      will develop tools that predict the risk of developing arthritis that will help doctors
      determine when surgery is necessary to prevent arthritis of the hand and wrist, and pain and
      disability.
A series of 60 participants (30 male: 30 female) with current distal radius fractures will be
      recruited. Clinical eligibility will include a unilateral DRF treated with closed reduction
      and casting. These measures will be assessed at baseline (<6 weeks following injury), 3- 6
      months and 12 months following fracture. A second series of 80 participants (40 male: 40
      female) who suffered a DRF ≥10 years previously will be recruited and tested. Exclusion
      criteria for these two cohorts will include presence of neurological disorders, rheumatoid
      arthritis or co-morbid health conditions that preclude completion of study measures. Twenty
      additional healthy participants will be recruited.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Healthy Population
primary purpose: Other
masking: None (Open Label)
measure: Hand Joint Spacing
time frame: 3 years
description: To measure joint spacing of the hand in a 3D ultrasound image
arm group label: Healthy Population
arm group type: Experimental
description: Healthy Individuals with no presence of neurological disorders, rheumatoid arthritis or comorbid health conditions, and are not pregnant.
intervention type: Device
intervention name: Ultrasound Imaging
description: The participant will go to the Rheumatology clinic (St. Joseph's Hospital) and have 3D hand ultrasound performed on their hands.
arm group label: Healthy Population
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Osteoarthritis