<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/NCT03749122</url>
  </required_header>
  <id_info>
    <org_study_id>331-16</org_study_id>
    <nct_id>NCT03749122</nct_id>
  </id_info>
  <brief_title>Time to Hip Fracture Surgery</brief_title>
  <official_title>Preoperative Waiting Time to Surgery Related to Mortality in Hip Fracture Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</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>
      The purpose of the study is to evaluate how time from hospital admission to start of surgery&#xD;
      influence mortality in patients with acute hip fracture. Data on patients with hip fracture&#xD;
      surgery will be collected from the hospital's registration system and will be analyzed&#xD;
      regarding age, gender, American Society of Anesthesiologists (ASA) Physical Status&#xD;
      Classification, type of surgery and time from admission to surgery along with data on&#xD;
      mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2006</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 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>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Date of Death captured through Swedish Taxation Authority within 30 days</description>
  </primary_outcome>
  <enrollment type="Actual">10000</enrollment>
  <condition>Hip Fractures</condition>
  <condition>Mortality</condition>
  <condition>Surgery</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Waiting time for hip fracture surgery</intervention_name>
    <description>Time from hospital admission to start of hip fracture surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute hip fracture&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: undergoing&#xD;
&#xD;
          -  hip fracture surgery between 2007-2016.&#xD;
&#xD;
          -  Over 60 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pathological fracture.&#xD;
&#xD;
          -  In-hospital falls.&#xD;
&#xD;
          -  Diagnostic delay.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Bengt Nellgard</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03749122
org study id: 331-16
nct id: NCT03749122
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate how time from hospital admission to start of surgery
      influence mortality in patients with acute hip fracture. Data on patients with hip fracture
      surgery will be collected from the hospital's registration system and will be analyzed
      regarding age, gender, American Society of Anesthesiologists (ASA) Physical Status
      Classification, type of surgery and time from admission to surgery along with data on
      mortality.
observational model: Cohort
time perspective: Retrospective
measure: Mortality
time frame: 30 days
description: Date of Death captured through Swedish Taxation Authority within 30 days
intervention type: Procedure
intervention name: Waiting time for hip fracture surgery
description: Time from hospital admission to start of hip fracture surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Bengt Nellgard
investigator title: Associate professor
mesh term: Fractures, Bone
mesh term: Hip Fractures
sharing ipd: No