<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/NCT01660490</url>
  </required_header>
  <id_info>
    <org_study_id>IO Image Quality</org_study_id>
    <nct_id>NCT01660490</nct_id>
  </id_info>
  <brief_title>Development and Validation of Intraoperative Image-quality Criteria</brief_title>
  <official_title>Development and Validation of Intraoperative Image-quality Criteria A Retrospective Multicenter Case Series to Validate a Set of Intraoperative Image-quality Criteria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AO Clinical Investigation and Publishing Documentation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AO Innovation Translation Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An expert panel of surgeons agreed that there is not any established, standardized approach&#xD;
      to the teaching of intraoperative imaging and that there may be practice gaps in decision&#xD;
      making and the use of imaging among trauma surgeons.&#xD;
&#xD;
      The panel is set to initiate a consensus-based evaluation process to develop a list of&#xD;
      criteria for assessing images and would like to validate these criteria for differentiating&#xD;
      good quality versus poor quality images in term of reliability and accuracy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate if C-Arm pictures can be a predictive factor for the outcome of repositioning of humerus fractures.</measure>
    <time_frame>Intraoperatively</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Proximal Femur Fractures</condition>
  <arm_group>
    <arm_group_label>Proximal femur fractures with ORIF</arm_group_label>
    <description>Proximal femur fractures treated with ORIF</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ORIF</intervention_name>
    <description>Open reduction internal fixation of the proximal femur</description>
    <arm_group_label>Proximal femur fractures with ORIF</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with a proximal femur fractures treated with ORIF between May 2010 and&#xD;
        December 2010&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of proximal femur fracture&#xD;
&#xD;
          -  Operated between May 2010 and December 2010&#xD;
&#xD;
          -  Open Reduction Internal Fixation (ORIF)&#xD;
&#xD;
          -  Lateral and anteroposterior intraoperative images available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Blauth, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Innsbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prof. Michael Blauth</name>
      <address>
        <city>Innsbruck</city>
        <state>Tyrol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>March 18, 2014</last_update_submitted>
  <last_update_submitted_qc>March 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiographic Image Enhancement,</keyword>
  <keyword>Intraoperative Care</keyword>
  <keyword>Femoral Fractures</keyword>
  <keyword>Femoral Neck Fractures</keyword>
  <keyword>Hip Fractures, Internal Fixators</keyword>
  <keyword>Fracture Fixation Internal</keyword>
  <keyword>Fracture Fixation Intramedullary</keyword>
  <keyword>Fractures Bone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femoral Fractures</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/NCT01660490
org study id: IO Image Quality
nct id: NCT01660490
lead sponsor: 
has dmc: No
An expert panel of surgeons agreed that there is not any established, standardized approach
      to the teaching of intraoperative imaging and that there may be practice gaps in decision
      making and the use of imaging among trauma surgeons.

      The panel is set to initiate a consensus-based evaluation process to develop a list of
      criteria for assessing images and would like to validate these criteria for differentiating
      good quality versus poor quality images in term of reliability and accuracy.
observational model: Case-Only
time perspective: Retrospective
measure: Evaluate if C-Arm pictures can be a predictive factor for the outcome of repositioning of humerus fractures.
time frame: Intraoperatively
arm group label: Proximal femur fractures with ORIF
description: Proximal femur fractures treated with ORIF
intervention type: Procedure
intervention name: ORIF
description: Open reduction internal fixation of the proximal femur
arm group label: Proximal femur fractures with ORIF
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Michael Blauth, Professor
role: Principal Investigator
affiliation: Medical University Innsbruck
facility: 
facility: 
facility: 
country: Austria
country: Switzerland
country: United States
responsible party type: Sponsor
mesh term: Femoral Fractures