<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/NCT03026920</url>
  </required_header>
  <id_info>
    <org_study_id>HZY2015</org_study_id>
    <nct_id>NCT03026920</nct_id>
  </id_info>
  <brief_title>Pelvic and Acetabular Fracture in Old People</brief_title>
  <official_title>Different Surgical Methods for Pelvic or Acetabular Fracture of Old Man</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebei Medical University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hebei Medical University Third Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It was reported that satisfactory postoperative outcome was difficult to obtain for the&#xD;
      pelvic or acetabular fracture in old people. The less invasive surgical method was conducted&#xD;
      in this study. Then, the clinical results were compared with the patients treated using&#xD;
      traditional methods to assess the less invasive method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pelvic or acetabular fractures were caused by high energy trauma, which may lead to poor&#xD;
      prognosis for the old. The patients over 60 years were included in this study. The surgical&#xD;
      procedure was conducted in two weeks. The less invasive methods involved Stoppa approach and&#xD;
      novel plate. The data including surgical time, blood loss and results of follow-up were&#xD;
      recorded. The clinical results were compared with the patients treated using traditional&#xD;
      methods. Thus, the clinical outcome of Pelvic or acetabular fractures in old man was&#xD;
      assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fracture union time</measure>
    <time_frame>4 months</time_frame>
    <description>how long the fracture line disappeared postoperatively in radiograph</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>complication</measure>
    <time_frame>12 months</time_frame>
    <description>wound infection, iatrogenic injury of vessels and nerves, nonunion</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Fracture Dislocation</condition>
  <arm_group>
    <arm_group_label>clinical outcome</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Less invasive method was applied to pelvic or acetabular fracture of old people. Thus, the clinical outcome of Pelvic or acetabular fractures in old man was assessed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>less invasive method</intervention_name>
    <description>The less invasive surgical method was conducted in this study. Then, the clinical results were compared with the patients treated using traditional methods to assess the less invasive method.</description>
    <arm_group_label>clinical outcome</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Over 60 years old Fracture involving pelvis or acetabulum Operation was conducted within 14&#xD;
        days Sign the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Presented with a pathologic acetabular fracture Refused to participate Follow-up&#xD;
        insufficient 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruipeng Zhang, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Third Hospital of Hebei Medical University Department of Orthopaedic Surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhiyong Hou, M.D</last_name>
    <phone>+8618533112800</phone>
    <email>houzhiyong1234@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hebei Medical University Third Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050051</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhiyong Hou, M.D</last_name>
      <phone>+8618533112800</phone>
      <email>houzhiyong1234@126.com</email>
    </contact>
    <investigator>
      <last_name>Ruipeng Zhang, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fracture</keyword>
  <keyword>outcome</keyword>
  <keyword>pelvic</keyword>
  <keyword>acetabular</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fracture Dislocation</mesh_term>
    <mesh_term>Fractures, Bone</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/NCT03026920
org study id: HZY2015
nct id: NCT03026920
lead sponsor: 
has dmc: No
It was reported that satisfactory postoperative outcome was difficult to obtain for the
      pelvic or acetabular fracture in old people. The less invasive surgical method was conducted
      in this study. Then, the clinical results were compared with the patients treated using
      traditional methods to assess the less invasive method.
Pelvic or acetabular fractures were caused by high energy trauma, which may lead to poor
      prognosis for the old. The patients over 60 years were included in this study. The surgical
      procedure was conducted in two weeks. The less invasive methods involved Stoppa approach and
      novel plate. The data including surgical time, blood loss and results of follow-up were
      recorded. The clinical results were compared with the patients treated using traditional
      methods. Thus, the clinical outcome of Pelvic or acetabular fractures in old man was
      assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: fracture union time
time frame: 4 months
description: how long the fracture line disappeared postoperatively in radiograph
measure: complication
time frame: 12 months
description: wound infection, iatrogenic injury of vessels and nerves, nonunion
arm group label: clinical outcome
arm group type: Experimental
description: Less invasive method was applied to pelvic or acetabular fracture of old people. Thus, the clinical outcome of Pelvic or acetabular fractures in old man was assessed.
intervention type: Procedure
intervention name: less invasive method
description: The less invasive surgical method was conducted in this study. Then, the clinical results were compared with the patients treated using traditional methods to assess the less invasive method.
arm group label: clinical outcome
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ruipeng Zhang, M.D
role: Principal Investigator
affiliation: Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
last name: Zhiyong Hou, M.D
phone: +8618533112800
email: houzhiyong1234@126.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Fracture Dislocation
mesh term: Fractures, Bone
sharing ipd: No