<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/NCT03764501</url>
  </required_header>
  <id_info>
    <org_study_id>18-19</org_study_id>
    <nct_id>NCT03764501</nct_id>
  </id_info>
  <brief_title>Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy</brief_title>
  <official_title>Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tokyo Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tokyo Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Utility of image fusion system for the fracture and fracture malunion management will be&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The fracture and malunion patients need osteosynthesis or osteotomy will be recruited. Image&#xD;
      fusion group utilizes 3D preoperative planning and image fusion system. Control group&#xD;
      utilizes only 3D preoperative planning. The age, sex, and fracture types will be matched&#xD;
      between groups. In both groups, 3D preoperative planning will be performed in order to&#xD;
      determine reduction, placement and choices of implants. In the image fusion group, the&#xD;
      outline of planned image will be displayed on the monitor overlapping with fluoroscopy image&#xD;
      during surgery. Reductions, implant choices/positions, and clinical outcomes will be&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 21, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 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>
    <intervention_model_description>Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction accuracy</measure>
    <time_frame>1month after the surgery</time_frame>
    <description>Reproducibility of the reduction shape will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implant placement</measure>
    <time_frame>1month after the surgery</time_frame>
    <description>Reproducibility of the implant placement will be evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implant choices</measure>
    <time_frame>1month after the surgery</time_frame>
    <description>Reproducibility of the implant choices will be evaluated.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Fractures, Bone</condition>
  <condition>Fracture Malunion, Bone</condition>
  <arm_group>
    <arm_group_label>Image fusion group (Image fusion)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group (ZedTrauma)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>only use 3D preoperative planning (Zed Trauma, LEXI Co., Ltd.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Image fusion system</intervention_name>
    <description>Image fusion system for the 3D preoperative planning</description>
    <arm_group_label>Image fusion group (Image fusion)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fracture paitents need osteosynthesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fracture patients under 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuichi M Yoshii</last_name>
    <phone>81298871161</phone>
    <phone_ext>81298871161</phone_ext>
    <email>yy12721@yahoo.co.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tokyo Medical University Ibaraki Medical Center</name>
      <address>
        <city>Ami</city>
        <state>Ibaraki</state>
        <zip>300-0395</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuichi Yoshii</last_name>
      <phone>81298871161</phone>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tokyo Medical University</investigator_affiliation>
    <investigator_full_name>Yuichi Yoshii</investigator_full_name>
    <investigator_title>Associate Professor, Department of Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Fractures, Malunited</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/NCT03764501
org study id: 18-19
nct id: NCT03764501
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Utility of image fusion system for the fracture and fracture malunion management will be
      evaluated.
The fracture and malunion patients need osteosynthesis or osteotomy will be recruited. Image
      fusion group utilizes 3D preoperative planning and image fusion system. Control group
      utilizes only 3D preoperative planning. The age, sex, and fracture types will be matched
      between groups. In both groups, 3D preoperative planning will be performed in order to
      determine reduction, placement and choices of implants. In the image fusion group, the
      outline of planned image will be displayed on the monitor overlapping with fluoroscopy image
      during surgery. Reductions, implant choices/positions, and clinical outcomes will be
      evaluated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction accuracy
time frame: 1month after the surgery
description: Reproducibility of the reduction shape will be measured.
measure: Implant placement
time frame: 1month after the surgery
description: Reproducibility of the implant placement will be evaluated.
measure: Implant choices
time frame: 1month after the surgery
description: Reproducibility of the implant choices will be evaluated.
arm group label: Image fusion group (Image fusion)
arm group type: Active Comparator
description: Use image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.)
arm group label: Control group (ZedTrauma)
arm group type: No Intervention
description: only use 3D preoperative planning (Zed Trauma, LEXI Co., Ltd.)
intervention type: Device
intervention name: Image fusion system
description: Image fusion system for the 3D preoperative planning
arm group label: Image fusion group (Image fusion)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuichi M Yoshii
phone: 81298871161
phone ext: 81298871161
email: yy12721@yahoo.co.jp
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Tokyo Medical University
investigator full name: Yuichi Yoshii
investigator title: Associate Professor, Department of Orthopaedic Surgery
mesh term: Fractures, Bone
mesh term: Fractures, Malunited
sharing ipd: No