<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/NCT03026868</url>
  </required_header>
  <id_info>
    <org_study_id>HZY2016</org_study_id>
    <nct_id>NCT03026868</nct_id>
  </id_info>
  <brief_title>Novel Quadrilateral Surface Plate for Acetabular Fracture</brief_title>
  <official_title>Randomized Trails of Different Fixations for Acetabular Fracture Involving Quadrilateral Surface</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The novel plate could be used to manage acetabular fractures involving quadrilateral surface&#xD;
      and posterior column, which may lower the intraoperative blood loss and reduce complication&#xD;
      rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and&#xD;
      acetabular fractures. Then, Stoppa approach was widely used clinically. For the fragments&#xD;
      involving quadrilateral surface, the Kocher-Langenbeck approach was added because the&#xD;
      fixation of posterior fragments could not be obtained with reconstruction plate through&#xD;
      single Stoppa approach. Novel quadrilateral surface plate was used in this study to examine&#xD;
      its fixed role for posterior fragments. Functional outcome and complication were recorded to&#xD;
      compare with the results treated with reconstruction plate. If good results were obtained for&#xD;
      the patients fixed with quadrilateral surface plate, it was meaningful to popularize the&#xD;
      fixed method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Anticipated">March 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 healing time</measure>
    <time_frame>4 months</time_frame>
    <description>fracture line disappeared in the radiograph</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>complication</measure>
    <time_frame>1 month</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">80</enrollment>
  <condition>Fracture Dislocation</condition>
  <arm_group>
    <arm_group_label>quadrilateral surface plate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>quadrilateral surface plate</intervention_name>
    <description>Both anterior and posterior approaches were always conducted to manage the fragments of quadrilateral surface. Novel quadrilateral surface plate was used in this study to examine whether the fragments could be fixed through single Stoppa approach.</description>
    <arm_group_label>quadrilateral surface plate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years old&#xD;
&#xD;
          -  Fracture involving quadrilateral surface&#xD;
&#xD;
          -  Operation was conducted within 14 days&#xD;
&#xD;
          -  Fixed with quadrilateral surface plate through Stoppa approach&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presented with a pathologic acetabular fracture&#xD;
&#xD;
          -  Neuropathic arthropathy,dementia and other disease processes which made postoperative&#xD;
             compliance unreliable&#xD;
&#xD;
          -  Refused to participate&#xD;
&#xD;
          -  Follow-up insufficient 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 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>Zhiyong Hou</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 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 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>acetabular</keyword>
  <keyword>quadrilateral surface plate</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/NCT03026868
org study id: HZY2016
nct id: NCT03026868
lead sponsor: 
has dmc: Yes
The novel plate could be used to manage acetabular fractures involving quadrilateral surface
      and posterior column, which may lower the intraoperative blood loss and reduce complication
      rate.
Stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and
      acetabular fractures. Then, Stoppa approach was widely used clinically. For the fragments
      involving quadrilateral surface, the Kocher-Langenbeck approach was added because the
      fixation of posterior fragments could not be obtained with reconstruction plate through
      single Stoppa approach. Novel quadrilateral surface plate was used in this study to examine
      its fixed role for posterior fragments. Functional outcome and complication were recorded to
      compare with the results treated with reconstruction plate. If good results were obtained for
      the patients fixed with quadrilateral surface plate, it was meaningful to popularize the
      fixed method.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: fracture healing time
time frame: 4 months
description: fracture line disappeared in the radiograph
measure: complication
time frame: 1 month
description: wound infection, iatrogenic injury of vessels and nerves, nonunion
arm group label: quadrilateral surface plate
arm group type: Experimental
description: The fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach.
intervention type: Procedure
intervention name: quadrilateral surface plate
description: Both anterior and posterior approaches were always conducted to manage the fragments of quadrilateral surface. Novel quadrilateral surface plate was used in this study to examine whether the fragments could be fixed through single Stoppa approach.
arm group label: quadrilateral surface plate
criteria: 
gender: All
minimum age: 18 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