<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/NCT03305640</url>
  </required_header>
  <id_info>
    <org_study_id>ALARIC</org_study_id>
    <nct_id>NCT03305640</nct_id>
  </id_info>
  <brief_title>Identification of an Atypical acetabuLar frActure With an Independent Roof Component: Incidence and Description</brief_title>
  <official_title>Identification of an Atypical acetabuLar frActure With an Independent Roof Component: Incidence and Description</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      Treatment of acetabular fractures needs a perfect diagnosis to anticipate surgical&#xD;
      difficulties. E. Letournel described a rare atypical both-column fracture which &quot; introduces&#xD;
      enormous surgical difficulties &quot;. Its particularity is a sagittal comminution interesting the&#xD;
      acetabular roof.&#xD;
&#xD;
      In this experience the particular fracture is probably under-diagnosed. The purpose of this&#xD;
      study is to give the exact incidence and a precise description of these fractures to improve&#xD;
      their surgical management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2016</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">August 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>measurement of volume-rendered 3D-CT images on preoperative CT-scans</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <enrollment type="Actual">35</enrollment>
  <condition>Acetabular Fracture</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>acetabular fracture surgery</intervention_name>
    <description>acetabular fracture surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        every patient with acute acetabular fractures managed in a single institution between 2007&#xD;
        and 2013&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with acetabular fracture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other type of fracture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Pomme JOUFFROY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHPSJ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</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/NCT03305640
org study id: ALARIC
nct id: NCT03305640
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment of acetabular fractures needs a perfect diagnosis to anticipate surgical
      difficulties. E. Letournel described a rare atypical both-column fracture which " introduces
      enormous surgical difficulties ". Its particularity is a sagittal comminution interesting the
      acetabular roof.

      In this experience the particular fracture is probably under-diagnosed. The purpose of this
      study is to give the exact incidence and a precise description of these fractures to improve
      their surgical management.
observational model: Cohort
time perspective: Retrospective
measure: measurement of volume-rendered 3D-CT images on preoperative CT-scans
time frame: Day 1
intervention type: Procedure
intervention name: acetabular fracture surgery
description: acetabular fracture surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Pomme JOUFFROY, MD
role: Principal Investigator
affiliation: GHPSJ
facility: 
country: France
responsible party type: Sponsor
mesh term: Fractures, Bone