<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/NCT03822000</url>
  </required_header>
  <id_info>
    <org_study_id>CDRPG8H0011-2</org_study_id>
    <nct_id>NCT03822000</nct_id>
  </id_info>
  <brief_title>Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture</brief_title>
  <official_title>Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture: A Cross-sectional Analysis Based on Trauma Registered Data</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to identify the risk factors and complications associated with mortality in&#xD;
      elderly patients with femoral fracture after a fall from the ground level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This retrospective study reviewed data pertaining to elderly patients aged ≥ 65 years who&#xD;
      were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2017.&#xD;
      Multivariate logistic regression analysis was performed to identify independent effects of&#xD;
      univariate predictive variables on the occurrence of mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">January 28, 2019</completion_date>
  <primary_completion_date type="Actual">January 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>up tp 2 months</time_frame>
    <description>Mortality was used as the primary outcome.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2407</enrollment>
  <condition>Femoral Fractures</condition>
  <arm_group>
    <arm_group_label>Elderly Patients with Femoral Fracture</arm_group_label>
    <description>Elderly patients with fall-induced femoral fracture. Patients were categorized into two groups: death (n = 42) and survival (n = 2,365).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survival</intervention_name>
    <description>Elderly patients with fall-induced femoral fracture who were survived.</description>
    <arm_group_label>Elderly Patients with Femoral Fracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Death</intervention_name>
    <description>Elderly patients with fall-induced femoral fracture who were dead.</description>
    <arm_group_label>Elderly Patients with Femoral Fracture</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This retrospective study reviewed data from 27,462 trauma patients registered between&#xD;
        January 1, 2009 and December 31, 2016. The inclusion criteria were age ≥65 years and&#xD;
        hospitalization for the treatment of femoral fracture following a fall from standing height&#xD;
        level (&lt;1 m). This study excluded those patients with a fall from ≥1 m as well as those for&#xD;
        whom incomplete data were available.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a fall from ≥1 m as well as those for whom incomplete data were&#xD;
             available.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those patients with a fall from ≥1 m&#xD;
&#xD;
          -  patients with incompleted data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>femur fracture</keyword>
  <keyword>trauma</keyword>
  <keyword>fall</keyword>
  <keyword>elderly</keyword>
  <keyword>mortality</keyword>
  <keyword>respiratory complication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <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/NCT03822000
org study id: CDRPG8H0011-2
nct id: NCT03822000
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to identify the risk factors and complications associated with mortality in
      elderly patients with femoral fracture after a fall from the ground level.
This retrospective study reviewed data pertaining to elderly patients aged ≥ 65 years who
      were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2017.
      Multivariate logistic regression analysis was performed to identify independent effects of
      univariate predictive variables on the occurrence of mortality.
observational model: Case-Control
time perspective: Retrospective
measure: Mortality
time frame: up tp 2 months
description: Mortality was used as the primary outcome.
arm group label: Elderly Patients with Femoral Fracture
description: Elderly patients with fall-induced femoral fracture. Patients were categorized into two groups: death (n = 42) and survival (n = 2,365).
intervention type: Other
intervention name: Survival
description: Elderly patients with fall-induced femoral fracture who were survived.
arm group label: Elderly Patients with Femoral Fracture
intervention type: Other
intervention name: Death
description: Elderly patients with fall-induced femoral fracture who were dead.
arm group label: Elderly Patients with Femoral Fracture
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Fractures