<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/NCT03800186</url>
  </required_header>
  <id_info>
    <org_study_id>CDRPG8H0011</org_study_id>
    <nct_id>NCT03800186</nct_id>
  </id_info>
  <brief_title>Influence of Age on Trauma Femoral Fractures</brief_title>
  <official_title>The Influence of Ageing on the Incidence and Site of Trauma Femoral Fractures: a Cross-sectional Analysis</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 determine the influence of ageing on the incidence and site of femoral&#xD;
      fractures in trauma patients, by taking the sex, body weight, and trauma mechanisms into&#xD;
      account.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This retrospective study reviewed data from adult trauma patients aged ≥ 20 years who were&#xD;
      admitted into a Level I trauma center, between January 1, 2009 and December 31, 2016.&#xD;
      According to the femoral fracture locations, 3859 adult patients with 4011 fracture sites&#xD;
      were grouped into five subgroups: proximal type A (n = 1,359), proximal type B (n= 1,487),&#xD;
      proximal type C (n = 59), femoral shaft (n = 640), and distal femur (n = 466) groups. A&#xD;
      multivariate logistic regression analysis was applied to identify independent effects of the&#xD;
      univariate predictive variables on the occurrence of fracture at a specific site. The&#xD;
      propensity score accounts for the risk of a fracture at a specific femoral site was&#xD;
      calculated and presented visually with age in a two-dimensional plot.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</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>Locations of femoral fracture</measure>
    <time_frame>up tp 2 months</time_frame>
    <description>To provide a summary of covariate information regarding the occurrence of femur Fractures at a specific site.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3859</enrollment>
  <condition>FEMORAL FRACTURES</condition>
  <arm_group>
    <arm_group_label>Trauma femoral fracture</arm_group_label>
    <description>Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients were grouping into five subgroups as patients with fracture of proximal type A, proximal type B, proximal type C, femoral shaft, and distal femur.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Proximal type A</intervention_name>
    <description>Patients with fracture of proximal type A</description>
    <arm_group_label>Trauma femoral fracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Proximal type B</intervention_name>
    <description>Patients with fracture of proximal type B</description>
    <arm_group_label>Trauma femoral fracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Proximal type C</intervention_name>
    <description>Patients with fracture of proximal type C</description>
    <arm_group_label>Trauma femoral fracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>femoral shaft</intervention_name>
    <description>Patients with fracture of femoral shaft</description>
    <arm_group_label>Trauma femoral fracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>distal femur</intervention_name>
    <description>Patients with fracture of distal femur</description>
    <arm_group_label>Trauma 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 required patients to be aged&#xD;
        ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients&#xD;
        with incomplete data were excluded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture&#xD;
             following injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with incomplete data were excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TSANG-TANG Hsieh, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <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 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</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>
    <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/NCT03800186
org study id: CDRPG8H0011
nct id: NCT03800186
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to determine the influence of ageing on the incidence and site of femoral
      fractures in trauma patients, by taking the sex, body weight, and trauma mechanisms into
      account.
This retrospective study reviewed data from adult trauma patients aged ≥ 20 years who were
      admitted into a Level I trauma center, between January 1, 2009 and December 31, 2016.
      According to the femoral fracture locations, 3859 adult patients with 4011 fracture sites
      were grouped into five subgroups: proximal type A (n = 1,359), proximal type B (n= 1,487),
      proximal type C (n = 59), femoral shaft (n = 640), and distal femur (n = 466) groups. A
      multivariate logistic regression analysis was applied to identify independent effects of the
      univariate predictive variables on the occurrence of fracture at a specific site. The
      propensity score accounts for the risk of a fracture at a specific femoral site was
      calculated and presented visually with age in a two-dimensional plot.
observational model: Case-Control
time perspective: Retrospective
measure: Locations of femoral fracture
time frame: up tp 2 months
description: To provide a summary of covariate information regarding the occurrence of femur Fractures at a specific site.
arm group label: Trauma femoral fracture
description: Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients were grouping into five subgroups as patients with fracture of proximal type A, proximal type B, proximal type C, femoral shaft, and distal femur.
intervention type: Other
intervention name: Proximal type A
description: Patients with fracture of proximal type A
arm group label: Trauma femoral fracture
intervention type: Other
intervention name: Proximal type B
description: Patients with fracture of proximal type B
arm group label: Trauma femoral fracture
intervention type: Other
intervention name: Proximal type C
description: Patients with fracture of proximal type C
arm group label: Trauma femoral fracture
intervention type: Other
intervention name: femoral shaft
description: Patients with fracture of femoral shaft
arm group label: Trauma femoral fracture
intervention type: Other
intervention name: distal femur
description: Patients with fracture of distal femur
arm group label: Trauma femoral fracture
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
last name: TSANG-TANG Hsieh, MD
role: Study Chair
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Fractures