<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/NCT02202122</url>
  </required_header>
  <id_info>
    <org_study_id>FNF-OSA</org_study_id>
    <nct_id>NCT02202122</nct_id>
  </id_info>
  <brief_title>Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures</brief_title>
  <official_title>Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the&#xD;
      prognosis of postoperative mortality after femoral neck fracture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  All patients incoming at the Saint-Luc Bouge Hospital with a femoral neck fracture&#xD;
&#xD;
        -  Study between 15/09/2014 and 15/10/2015&#xD;
&#xD;
        -  The four OSA predictive scores will be collected&#xD;
&#xD;
        -  Evaluation of mortality at 1 month&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    lack of investigators&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Impact OSA predictive scores on mortality prognosis</measure>
    <time_frame>1 month</time_frame>
    <description>Impact of the four major OSA predictive scores (STOP-BANG, P-SAP, OSA50 et DES-OSA) on the mortality prognosis after surgery for femoral neck fracture</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Femoral Neck Fracture</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>OSA Scoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OSA Scoring</intervention_name>
    <description>Comparison of the preoperative OSA scoring (STOP-BANG, DES-OSA, P-SAP and OSA50) with the postoperative mortality at one month.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with femoral neck fractures&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with femoral neck fractures&#xD;
&#xD;
          -  Incoming at the Saint-Luc Bouge Hospital&#xD;
&#xD;
          -  Between 15/09/2014 and 15/10/2015&#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>Eric P Deflandre, MD, FCCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Astes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Saint-Luc de Bouge</name>
      <address>
        <city>Namur</city>
        <zip>5100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>June 22, 2015</last_update_submitted>
  <last_update_submitted_qc>June 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Astes</investigator_affiliation>
    <investigator_full_name>Eric DEFLANDRE, MD, FCCP</investigator_full_name>
    <investigator_title>Eric DEFLANDRE, MD, FCCP</investigator_title>
  </responsible_party>
  <keyword>Femoral Neck Fractures</keyword>
  <keyword>Obstructive Sleep Apnea</keyword>
  <keyword>Perioperative Complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Neck 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/NCT02202122
org study id: FNF-OSA
nct id: NCT02202122
lead sponsor: 
has dmc: No
Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the
      prognosis of postoperative mortality after femoral neck fracture.
-  All patients incoming at the Saint-Luc Bouge Hospital with a femoral neck fracture

        -  Study between 15/09/2014 and 15/10/2015

        -  The four OSA predictive scores will be collected

        -  Evaluation of mortality at 1 month
observational model: Cohort
time perspective: Prospective
measure: Impact OSA predictive scores on mortality prognosis
time frame: 1 month
description: Impact of the four major OSA predictive scores (STOP-BANG, P-SAP, OSA50 et DES-OSA) on the mortality prognosis after surgery for femoral neck fracture
arm group label: Study Group
description: OSA Scoring
intervention type: Other
intervention name: OSA Scoring
description: Comparison of the preoperative OSA scoring (STOP-BANG, DES-OSA, P-SAP and OSA50) with the postoperative mortality at one month.
arm group label: Study Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eric P Deflandre, MD, FCCP
role: Principal Investigator
affiliation: Astes
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Astes
investigator full name: Eric DEFLANDRE, MD, FCCP
investigator title: Eric DEFLANDRE, MD, FCCP
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Fractures, Bone
mesh term: Femoral Neck Fractures