xml: <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/NCT06002308</url>
    </required_header>
    <id_info>
      <org_study_id>KY2023-018-01</org_study_id>
      <nct_id>NCT06002308</nct_id>
    </id_info>
    <brief_title>Influence of Injury to the Kaplan Fibers in Adult and Pediatric Patients With ACL Injury</brief_title>
    <official_title>Influence of Injury to the Kaplan Fibers and Anterolateral Ligament on Anterolateral Rotatory Knee Laxity in Adult and Pediatric Patients With Anterior Cruciate Ligament Injury: A Retrospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sichuan Province Orthopetic Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sichuan Province Orthopetic Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this [type of study: observational study] is to [detect concomitant KF and ALL&#xD;
        injury in knees with ACL injury using MRI in both adult and pediatric patients and compare&#xD;
        the effect of KF injury and multiple risk factors (concomitant injury to the ALL, medial&#xD;
        collateral ligament [MCL], or anterior, central, or posterior part of the medial or lateral&#xD;
        meniscus) on anterolateral rotatory laxity as measured by the pivot-shift test in a clinical&#xD;
        setting.].&#xD;
  &#xD;
        The main question [s] it aims to answer are:&#xD;
  &#xD;
        [Does the main risk factor for a high-grade pivot shift after acute ACL injury differ between&#xD;
        pediatric patients and adults?] [Does Concomitant KF injury significantly affect the&#xD;
        pivot-shift phenomenon in pediatric patients with acute ACL injury?] Researchers will compare&#xD;
        [71 pediatric patients and 469 adults] to see if [main risk factor for a high-grade pivot&#xD;
        shift after acute ACL injury differs between pediatric patients and adults?].&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 20, 2023</start_date>
    <completion_date type="Actual">June 22, 2023</completion_date>
    <primary_completion_date type="Actual">June 22, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>KF injury</measure>
      <time_frame>3 years</time_frame>
      <description>concomitant KF injury or not</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ALL injury</measure>
      <time_frame>3 years</time_frame>
      <description>concomitant ALL injury or not</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MCL injury</measure>
      <time_frame>3 years</time_frame>
      <description>concomitant MCL injury or not</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Medial meniscus injury</measure>
      <time_frame>3 years</time_frame>
      <description>concomitant anterior, central, or posterior part of medial meniscus injury or not</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lateral meniscus</measure>
      <time_frame>3 years</time_frame>
      <description>concomitant anterior, central, or posterior part of lateral meniscus injury or not</description>
    </primary_outcome>
    <enrollment type="Actual">540</enrollment>
    <condition>ACL-injury</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Age</intervention_name>
      <description>The retrospective study included 540 patients with primary ACL tears (71 pediatric patients and 469 adults) whose MRI examination and pivot-shift test were conducted within 14 days after injury. To detect concomitant KF and ALL injury in knees with ACL injury using MRI in both adult and pediatric patients and compare the effect of KF injury and multiple risk factors on anterolateral rotatory laxity as measured by the pivot-shift test in a clinical setting.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          1994 patients were identified from medical records between Jan. 2019 and Dec. 2021. After&#xD;
          reviewing the inclusion and exclusion criteria, 540 patients were included in the present&#xD;
          study (71 pediatric patients and 469 adults).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  unilateral acute primary ACL tear, considered when the patient reported knee injury&#xD;
               occurring less than 2 weeks before the examination;&#xD;
  &#xD;
            -  bone bruising on the femoral condyles and tibial plateau identiﬁed on MRI.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  concomitant ligament (posterior cruciate ligament and/or posterolateral complex)&#xD;
               procedures or realignment procedures; contralateral knee injury;&#xD;
  &#xD;
            -  previous injury or surgery affecting the ipsilateral knee;&#xD;
  &#xD;
            -  insufficient data from the electronic medical record system;&#xD;
  &#xD;
            -  lack of KF visualization on MRI.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Sichuan Provincial Orthopedic Hospital</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sichuan Province Orthopetic Hospital</investigator_affiliation>
      <investigator_full_name>Jiaming Cui</investigator_full_name>
      <investigator_title>Attending Doctor</investigator_title>
    </responsible_party>
    <keyword>Rotatory instability</keyword>
    <keyword>Kaplan fiber injury</keyword>
    <keyword>Anterolateral ligament</keyword>
    <keyword>Meniscal injury</keyword>
    <keyword>Magnetic resonance imaging</keyword>
    <keyword>Anterior cruciate ligament</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002308
  org study id: KY2023-018-01
  nct id: NCT06002308
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this [type of study: observational study] is to [detect concomitant KF and ALL
        injury in knees with ACL injury using MRI in both adult and pediatric patients and compare
        the effect of KF injury and multiple risk factors (concomitant injury to the ALL, medial
        collateral ligament [MCL], or anterior, central, or posterior part of the medial or lateral
        meniscus) on anterolateral rotatory laxity as measured by the pivot-shift test in a clinical
        setting.].
  
        The main question [s] it aims to answer are:
  
        [Does the main risk factor for a high-grade pivot shift after acute ACL injury differ between
        pediatric patients and adults?] [Does Concomitant KF injury significantly affect the
        pivot-shift phenomenon in pediatric patients with acute ACL injury?] Researchers will compare
        [71 pediatric patients and 469 adults] to see if [main risk factor for a high-grade pivot
        shift after acute ACL injury differs between pediatric patients and adults?].
  observational model: Cohort
  time perspective: Retrospective
  measure: KF injury
  time frame: 3 years
  description: concomitant KF injury or not
  measure: ALL injury
  time frame: 3 years
  description: concomitant ALL injury or not
  measure: MCL injury
  time frame: 3 years
  description: concomitant MCL injury or not
  measure: Medial meniscus injury
  time frame: 3 years
  description: concomitant anterior, central, or posterior part of medial meniscus injury or not
  measure: Lateral meniscus
  time frame: 3 years
  description: concomitant anterior, central, or posterior part of lateral meniscus injury or not
  intervention type: Other
  intervention name: Age
  description: The retrospective study included 540 patients with primary ACL tears (71 pediatric patients and 469 adults) whose MRI examination and pivot-shift test were conducted within 14 days after injury. To detect concomitant KF and ALL injury in knees with ACL injury using MRI in both adult and pediatric patients and compare the effect of KF injury and multiple risk factors on anterolateral rotatory laxity as measured by the pivot-shift test in a clinical setting.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sichuan Province Orthopetic Hospital
  investigator full name: Jiaming Cui
  investigator title: Attending Doctor
  mesh term: Wounds and Injuries
  mesh term: Anterior Cruciate Ligament Injuries