<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/NCT02971943</url>
  </required_header>
  <id_info>
    <org_study_id>FirstHebei_001</org_study_id>
    <nct_id>NCT02971943</nct_id>
  </id_info>
  <brief_title>Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging</brief_title>
  <official_title>Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging: a Retrospective, Self-controlled, Clinical Trial With 3-month Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Hospital of Hebei Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To verify whether X-ray combined with MRI is able to carry out correct fracture&#xD;
      classification and postoperative evaluation in patients with ankle fractures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      History and current related studies Intraarticular fractures and ruptures of ligaments around&#xD;
      the joint often occur after ankle injury. Early correct treatment can effectively help joint&#xD;
      repair, and reduce the incidence of serious complications. Ankle fractures are one of the&#xD;
      common orthopedic fractures. X-ray is a common method for detecting ankle injury, can&#xD;
      determine the fracture site, type and extent. However, X-ray is difficult to display ankle&#xD;
      fracture, bone fragments, displacement, or ligament injury, so it cannot make accurate&#xD;
      fracture classification or formulate treatment programs.&#xD;
&#xD;
      Magnetic resonance imaging (MRI) can clearly show the ankle ligament, tendon, and cartilage&#xD;
      injury, is advantageous in the diagnosis of ligament injury after ankle fracture, and can&#xD;
      provide accurate imaging information. MRI can provide accurate preoperative assessment of&#xD;
      clinical indicators for the rational formulation of treatment programs to reduce&#xD;
      complications. The observation of ankle contusion observed by MRI is conducive to analyzing&#xD;
      the mechanism of ankle joint injury.&#xD;
&#xD;
      Therefore, X-ray combined with MRI would perfectly verify soft tissue injury after ankle&#xD;
      fractures so as to make effective surgical program.&#xD;
&#xD;
      Adverse events Adverse events including incision pain, incision nonunion, ankle pain,&#xD;
      peripheral nerve injury of ankle joint, ankle joint inflammation, and soft tissue injury.&#xD;
      Severe adverse events are events occurred during clinical trial, including requiring&#xD;
      hospitalization, prolonged hospitalization, disability, inability to work, life-threatening,&#xD;
      or fatalities. If severe adverse events occur, investigators would report details, including&#xD;
      the date of occurrence and measures taken to treat the adverse events, to the principle&#xD;
      investigator and the institutional review board within 24 hours.&#xD;
&#xD;
      Data collection, management, analysis and open-access&#xD;
&#xD;
        1. Case report forms with demographic data, disease diagnosis, accompanying diseases, drug&#xD;
           allergy history, and adverse events were collected.&#xD;
&#xD;
        2. Data were processed using Epidata software (Epidata Association, Odense, Denmark),&#xD;
           collated, and then recorded electronically. All data regarding this trial were preserved&#xD;
           by the First Hospital, Hebei Medical University, China.&#xD;
&#xD;
        3. The electronic database was statistically analyzed by a professional statistician who&#xD;
           created an outcome analysis report that was submitted to the lead researchers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Percentage of patients with excellent effects</measure>
    <time_frame>at postoperative 3 months</time_frame>
    <description>higher value indicates better repair effect</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patients with Lauge-Hansen classification</measure>
    <time_frame>baseline</time_frame>
    <description>According to the degree of bone and ligament injury, there are supination-external rotation (supination-eversion), pronation-external rotation (pronation-eversion), supination-adduction and pronation-abduction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>X-ray examination</measure>
    <time_frame>baseline and 3 months postoperatively</time_frame>
    <description>To evaluate the healing degree of fracture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI findings</measure>
    <time_frame>baseline and 3 months postoperatively</time_frame>
    <description>To evaluate ligament repair effects</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Ankle Injury</condition>
  <arm_group>
    <arm_group_label>internal fixation for ankle fractures</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging preoperatively and 3 months postoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>internal fixation for ankle fractures</intervention_name>
    <description>The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging.</description>
    <arm_group_label>internal fixation for ankle fractures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ankle fractures patients detected by X-ray&#xD;
&#xD;
          -  Highly suspected ankle ligament injury&#xD;
&#xD;
          -  History of obvious trauma&#xD;
&#xD;
          -  Complete clinical data&#xD;
&#xD;
          -  Irrespective of sex and age&#xD;
&#xD;
          -  Sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiopulmonary function cannot tolerate anesthesia or surgery&#xD;
&#xD;
          -  Open fractures of ankle joint&#xD;
&#xD;
          -  Old fracture of the ankle joint&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guobin Liu, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Hebei Medical University</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 20, 2016</last_update_submitted>
  <last_update_submitted_qc>November 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Hospital of Hebei Medical University</investigator_affiliation>
    <investigator_full_name>Guobin Liu</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Ankle Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02971943
org study id: FirstHebei_001
nct id: NCT02971943
lead sponsor: 
has dmc: Yes
To verify whether X-ray combined with MRI is able to carry out correct fracture
      classification and postoperative evaluation in patients with ankle fractures.
History and current related studies Intraarticular fractures and ruptures of ligaments around
      the joint often occur after ankle injury. Early correct treatment can effectively help joint
      repair, and reduce the incidence of serious complications. Ankle fractures are one of the
      common orthopedic fractures. X-ray is a common method for detecting ankle injury, can
      determine the fracture site, type and extent. However, X-ray is difficult to display ankle
      fracture, bone fragments, displacement, or ligament injury, so it cannot make accurate
      fracture classification or formulate treatment programs.

      Magnetic resonance imaging (MRI) can clearly show the ankle ligament, tendon, and cartilage
      injury, is advantageous in the diagnosis of ligament injury after ankle fracture, and can
      provide accurate imaging information. MRI can provide accurate preoperative assessment of
      clinical indicators for the rational formulation of treatment programs to reduce
      complications. The observation of ankle contusion observed by MRI is conducive to analyzing
      the mechanism of ankle joint injury.

      Therefore, X-ray combined with MRI would perfectly verify soft tissue injury after ankle
      fractures so as to make effective surgical program.

      Adverse events Adverse events including incision pain, incision nonunion, ankle pain,
      peripheral nerve injury of ankle joint, ankle joint inflammation, and soft tissue injury.
      Severe adverse events are events occurred during clinical trial, including requiring
      hospitalization, prolonged hospitalization, disability, inability to work, life-threatening,
      or fatalities. If severe adverse events occur, investigators would report details, including
      the date of occurrence and measures taken to treat the adverse events, to the principle
      investigator and the institutional review board within 24 hours.

      Data collection, management, analysis and open-access

        1. Case report forms with demographic data, disease diagnosis, accompanying diseases, drug
           allergy history, and adverse events were collected.

        2. Data were processed using Epidata software (Epidata Association, Odense, Denmark),
           collated, and then recorded electronically. All data regarding this trial were preserved
           by the First Hospital, Hebei Medical University, China.

        3. The electronic database was statistically analyzed by a professional statistician who
           created an outcome analysis report that was submitted to the lead researchers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients with excellent effects
time frame: at postoperative 3 months
description: higher value indicates better repair effect
measure: patients with Lauge-Hansen classification
time frame: baseline
description: According to the degree of bone and ligament injury, there are supination-external rotation (supination-eversion), pronation-external rotation (pronation-eversion), supination-adduction and pronation-abduction.
measure: X-ray examination
time frame: baseline and 3 months postoperatively
description: To evaluate the healing degree of fracture
measure: MRI findings
time frame: baseline and 3 months postoperatively
description: To evaluate ligament repair effects
arm group label: internal fixation for ankle fractures
arm group type: Other
description: The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging preoperatively and 3 months postoperatively.
intervention type: Procedure
intervention name: internal fixation for ankle fractures
description: The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging.
arm group label: internal fixation for ankle fractures
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Guobin Liu, Master
role: Principal Investigator
affiliation: The First Affiliated Hospital of Hebei Medical University
responsible party type: Principal Investigator
investigator affiliation: The First Hospital of Hebei Medical University
investigator full name: Guobin Liu
investigator title: Chief Physician
mesh term: Wounds and Injuries
mesh term: Ankle Injuries
sharing ipd: Undecided