<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/NCT03040739</url>
  </required_header>
  <id_info>
    <org_study_id>COTYLE_O'ARM</org_study_id>
    <nct_id>NCT03040739</nct_id>
  </id_info>
  <brief_title>Treatment of Acetabulum Fracture With O'ARM Surgical Imaging</brief_title>
  <official_title>Treatment of Acetabulum Fracture With O'ARM Surgical Imaging</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>
      Acetabulum fracture are high energy trauma in young people as it can be the result of a&#xD;
      simple fall in elder people. This fracture generates an incongruity between acetabulum and&#xD;
      femoral head. So surgery is recognized as the best treatment even if technically difficult&#xD;
      because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery .&#xD;
&#xD;
      The aim of the study is to evaluate the effect of peroperative navigation system on reduction&#xD;
      of the acetabulum articular surface&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2016</start_date>
  <completion_date type="Actual">June 15, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Height of incongruity</measure>
    <time_frame>Day 1</time_frame>
    <description>Reduction of the articular surface of the acetabulum</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">56</enrollment>
  <condition>Acetabulum Fracture</condition>
  <arm_group>
    <arm_group_label>case</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>use of O'ARM imaging system</intervention_name>
    <description>use of O'ARM imaging system</description>
    <arm_group_label>case</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Every patients admitted in the service of orthopaedic surgery for fracture of the cotyle&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  acetabulum fracture dating less than a month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>September 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>O'ARM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03040739
org study id: COTYLE_O'ARM
nct id: NCT03040739
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acetabulum fracture are high energy trauma in young people as it can be the result of a
      simple fall in elder people. This fracture generates an incongruity between acetabulum and
      femoral head. So surgery is recognized as the best treatment even if technically difficult
      because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery .

      The aim of the study is to evaluate the effect of peroperative navigation system on reduction
      of the acetabulum articular surface
observational model: Case-Control
time perspective: Prospective
measure: Height of incongruity
time frame: Day 1
description: Reduction of the articular surface of the acetabulum
arm group label: case
arm group label: control
intervention type: Other
intervention name: use of O'ARM imaging system
description: use of O'ARM imaging system
arm group label: case
arm group label: control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Fractures, Bone
sharing ipd: Undecided