<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/NCT01670344</url>
  </required_header>
  <id_info>
    <org_study_id>10308644 Final 2.5</org_study_id>
    <nct_id>NCT01670344</nct_id>
  </id_info>
  <brief_title>Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions</brief_title>
  <acronym>VIPS</acronym>
  <official_title>Virtual Implant Planning System - A Method to Support Image-guided Surgical Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Siemens Healthcare QT</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Siemens Healthcare QT</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative&#xD;
      positioning system in the clinical setting of orthopedic surgery.&#xD;
&#xD;
      Aim of the study is the validation and comparison of the innovative medical device with the&#xD;
      current standard method.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of screw replacements in both treatments arms</measure>
    <time_frame>Participants will be followed for the duration of the hospital stay, an expected average of 3 days</time_frame>
    <description>The number of screw replacements in both treatment arms will be assessed to evaluate the investigational method in comparison to the standard of care (arm B)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the investigational method to the standard of care regarding radiation time.</measure>
    <time_frame>Participants will be followed for the duration of the hospital stay, an expected average of 3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events and serious adverse events during the clinical investigarion.</measure>
    <time_frame>Participants will be followed for the duration of the hospital stay, an expected average of 3 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Fracture of Distal End of Radius</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment with investigational method (virtual implant positioning system)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment with surgical standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Treatment with investigational method (virtual implant positioning system)</intervention_name>
    <arm_group_label>A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Treatment with surgical standard of care</intervention_name>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diastal fracture of the radius&#xD;
&#xD;
          -  Patients with the mentioned fracture and indication for surgical treatment according&#xD;
             to national guidelines&#xD;
&#xD;
          -  Age &gt;/= 18 years of age&#xD;
&#xD;
          -  Patients willing to participate and after having given their informed consent in&#xD;
             written form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in other interventional clinical trials&#xD;
&#xD;
          -  Pregnant or lactating women&#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_official>
    <last_name>Kleinszig Gerhard, MSc</last_name>
    <role>Study Director</role>
    <affiliation>Sponsor GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siemens AG Healthcare Sector</name>
      <address>
        <city>Erlangen</city>
        <zip>91052</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>June 20, 2013</last_update_submitted>
  <last_update_submitted_qc>June 20, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 21, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01670344
org study id: 10308644 Final 2.5
nct id: NCT01670344
lead sponsor: 
has dmc: No
This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative
      positioning system in the clinical setting of orthopedic surgery.

      Aim of the study is the validation and comparison of the innovative medical device with the
      current standard method.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of screw replacements in both treatments arms
time frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
description: The number of screw replacements in both treatment arms will be assessed to evaluate the investigational method in comparison to the standard of care (arm B)
measure: Comparison of the investigational method to the standard of care regarding radiation time.
time frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
measure: Number of adverse events and serious adverse events during the clinical investigarion.
time frame: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
arm group label: A
arm group type: Other
description: Treatment with investigational method (virtual implant positioning system)
arm group label: B
arm group type: Other
description: Treatment with surgical standard of care
intervention type: Procedure
intervention name: Treatment with investigational method (virtual implant positioning system)
arm group label: A
intervention type: Procedure
intervention name: Treatment with surgical standard of care
arm group label: B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kleinszig Gerhard, MSc
role: Study Director
affiliation: Sponsor GmbH
facility: 
country: Germany
responsible party type: Sponsor