<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/NCT04455386</url>
  </required_header>
  <id_info>
    <org_study_id>PKU-GUO-02</org_study_id>
    <nct_id>NCT04455386</nct_id>
  </id_info>
  <brief_title>Diagnostic Study of Lateral Ligament Complex Injury of Ankle</brief_title>
  <official_title>Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Ligament Complex Injury of Ankle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Collateral Ligament&#xD;
      Injury of Ankle&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The lateral ligament complex of ankle joint consisting of the anterior&#xD;
      talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior&#xD;
      talofibular ligament (PTFL), is often injured by an ankle sprain. Improper diagnosis and&#xD;
      treatment of lateral ligament complex injury are not only prone to recurrent sprain, pain,&#xD;
      swelling and other symptoms, but also can lead to chronic lateral ankle instability, and&#xD;
      osteoarthritis, which could seriously affect the joint motor function.&#xD;
&#xD;
      Method and objective: This study is a prospective diagnostic test. By comparing the&#xD;
      sensitivity and specificity of stress X-ray, B-ultrasound, Computed tomography (CT), and&#xD;
      Magnetic resonance imaging (MRI), and analyzing the imaging manifestations and&#xD;
      characteristics of different diagnostic methods of lateral chronic ankle instability, We aim&#xD;
      to propose the criteria of the imaging diagnosis of lateral ankle ligament injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>anterior talar translation and talar tilt</measure>
    <time_frame>before operation</time_frame>
    <description>Assess the instability through stress X ray of the ankle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>length of ATFL and CFL in relax and stress position</measure>
    <time_frame>before operation</time_frame>
    <description>Assess the instability through Ultrasound of the ankle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morphology of ATFL and CFL</measure>
    <time_frame>before operation</time_frame>
    <description>Assess the ATFL and CFL through MRI of the ankle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>status of ATFL and CFL</measure>
    <time_frame>during operation</time_frame>
    <description>evaluation of ATFL and CFL during operation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>avulsion fracture</measure>
    <time_frame>before operation</time_frame>
    <description>avulsion fracture found by X ray, Ultrasound, CT or MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>osteophyte</measure>
    <time_frame>before operation</time_frame>
    <description>osteophyte found by X ray, Ultrasound, CT or MRI</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Chronic Instability of Ankle Joint</condition>
  <condition>Lateral Ligament Complex Injury of Ankle</condition>
  <arm_group>
    <arm_group_label>stable</arm_group_label>
    <description>The anterior drawer test and/or talar tilt test are negative and the ankle joint is stable.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>slightly instable</arm_group_label>
    <description>The anterior drawer test and/or talar tilt test are slightly positive and the ankle joint is partially instable.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>obviously instable</arm_group_label>
    <description>The anterior drawer test and/or talar tilt test is significantly positive, with significantly instable. The ankle joint is completely instable and can featured with dimple sign.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy</intervention_name>
    <description>All patients suspected chronic ankle instability, will perform an anterior drawer test, stress ultrasound, computed tomography, magnetic resonance imaging of ankle. Patients with chronic ankle instability will be recommended to perform an arthroscopic repair if non-operative treatment failed.</description>
    <arm_group_label>obviously instable</arm_group_label>
    <arm_group_label>slightly instable</arm_group_label>
    <arm_group_label>stable</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic lateral ligament complex injury of the ankle were divided into 3&#xD;
        groups and each group with 25 cases, according to the anterior drawer test and talar tilt&#xD;
        test.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic lateral ankle ligament injury due to ankle sprain in patients over 16 years of&#xD;
             age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute and subacute injury of the lateral ligament complex of the ankle joint (less&#xD;
             than 3 months), malalignment of ankle (more than 5 degrees), osteoarthritis (stage&#xD;
             IV).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qinwei Guo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qinwei Guo</last_name>
    <phone>18601129252</phone>
    <email>guoqinwei@vip.sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anhong Wang</last_name>
    <phone>18501325799</phone>
    <email>wah1995@pku.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute of Sports Medicine</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qinwei Guo, MD</last_name>
      <phone>86+18601129252</phone>
      <email>guoqinwei@vip.sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Third Hospital</investigator_affiliation>
    <investigator_full_name>Guo Qinwei</investigator_full_name>
    <investigator_title>associated professor</investigator_title>
  </responsible_party>
  <keyword>Lateral Ligament complex</keyword>
  <keyword>Ankle</keyword>
  <keyword>Diagnostic Methods</keyword>
  <keyword>Chronic Lateral Instability of Ankle</keyword>
  <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>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/NCT04455386
org study id: PKU-GUO-02
nct id: NCT04455386
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Collateral Ligament
      Injury of Ankle
Background: The lateral ligament complex of ankle joint consisting of the anterior
      talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior
      talofibular ligament (PTFL), is often injured by an ankle sprain. Improper diagnosis and
      treatment of lateral ligament complex injury are not only prone to recurrent sprain, pain,
      swelling and other symptoms, but also can lead to chronic lateral ankle instability, and
      osteoarthritis, which could seriously affect the joint motor function.

      Method and objective: This study is a prospective diagnostic test. By comparing the
      sensitivity and specificity of stress X-ray, B-ultrasound, Computed tomography (CT), and
      Magnetic resonance imaging (MRI), and analyzing the imaging manifestations and
      characteristics of different diagnostic methods of lateral chronic ankle instability, We aim
      to propose the criteria of the imaging diagnosis of lateral ankle ligament injury.
observational model: Cohort
time perspective: Prospective
measure: anterior talar translation and talar tilt
time frame: before operation
description: Assess the instability through stress X ray of the ankle
measure: length of ATFL and CFL in relax and stress position
time frame: before operation
description: Assess the instability through Ultrasound of the ankle
measure: Morphology of ATFL and CFL
time frame: before operation
description: Assess the ATFL and CFL through MRI of the ankle
measure: status of ATFL and CFL
time frame: during operation
description: evaluation of ATFL and CFL during operation
measure: avulsion fracture
time frame: before operation
description: avulsion fracture found by X ray, Ultrasound, CT or MRI
measure: osteophyte
time frame: before operation
description: osteophyte found by X ray, Ultrasound, CT or MRI
arm group label: stable
description: The anterior drawer test and/or talar tilt test are negative and the ankle joint is stable.
arm group label: slightly instable
description: The anterior drawer test and/or talar tilt test are slightly positive and the ankle joint is partially instable.
arm group label: obviously instable
description: The anterior drawer test and/or talar tilt test is significantly positive, with significantly instable. The ankle joint is completely instable and can featured with dimple sign.
intervention type: Diagnostic Test
intervention name: Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy
description: All patients suspected chronic ankle instability, will perform an anterior drawer test, stress ultrasound, computed tomography, magnetic resonance imaging of ankle. Patients with chronic ankle instability will be recommended to perform an arthroscopic repair if non-operative treatment failed.
arm group label: obviously instable
arm group label: slightly instable
arm group label: stable
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Qinwei Guo
role: Principal Investigator
affiliation: Peking University Third Hospital
last name: Qinwei Guo
phone: 18601129252
email: guoqinwei@vip.sina.com
last name: Anhong Wang
phone: 18501325799
email: wah1995@pku.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Third Hospital
investigator full name: Guo Qinwei
investigator title: associated professor
mesh term: Wounds and Injuries
mesh term: Ankle Injuries
sharing ipd: No