<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/NCT04454593</url>
  </required_header>
  <id_info>
    <org_study_id>M2019464</org_study_id>
    <nct_id>NCT04454593</nct_id>
  </id_info>
  <brief_title>Novel Method for Diagnosing Lateral Patellar Compression Syndrome Using X-ray: a Retrospective Case-Control Study</brief_title>
  <official_title>Novel Method for Diagnosing Lateral Patellar Compression Syndrome Using X-ray: a Retrospective Case-Control Study</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>No</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>
      This study evaluates whether the patellar axial radiograph of lateral patellar curvature&#xD;
      angle （LPCA）with knee flexion at 30 ° can be used as a new diagnostic surrogate of lateral&#xD;
      patellar compression syndrome（LPCS）. We believe that the new index LPCA has high sensitivity&#xD;
      and specificity in initial diagnosis of LPCS using axial patellar radiograph with knee&#xD;
      flexion at 30 ° , and has high application value.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: A well-established reference is lacking for diagnosing lateral patellar&#xD;
      compression syndrome (LPCS), and this diagnosis currently depends on clinicians' subjective&#xD;
      judgment and several examination results. X-rays are primarily used to diagnose LPCS, but&#xD;
      they have low detection rates of patellar tilt using the congruence angle (CA) and patellar&#xD;
      tilting angle (PTA).&#xD;
&#xD;
      Purpose: To investigate whether patellar axial radiography of the lateral patellar curvature&#xD;
      angle (LPCA) of knee in 30° flexion can diagnose LPCS.&#xD;
&#xD;
      Methods: We enrolled 87 patients between 2016 and 2019 and divided them as per diagnosis into&#xD;
      three groups of 29 each: LPCS, patellar dislocation (PD, control), and meniscus tear (MT,&#xD;
      negative control) groups. A senior radiologist and the chief physician of sports medicine&#xD;
      examined their patellar axial radiographs of the knee in 30° flexion using a computer imaging&#xD;
      system, measuring LPCA, PTA, and CA. Univariate analysis of variance and Kruskal-Wallis H&#xD;
      test were used to compare measurement data with normal distribution and non-normal&#xD;
      distribution, respectively. Bonferroni correction was used to analyze different indicators&#xD;
      for different groups. The area under the curve (AUC) was calculated to verify the value of&#xD;
      LPCA in initial diagnosis of LPCS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2020</start_date>
  <completion_date type="Actual">May 22, 2020</completion_date>
  <primary_completion_date type="Actual">April 22, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>lateral patellar curvature angle</measure>
    <time_frame>between 2016 and 2019</time_frame>
    <description>lateral patellar curvature angle in three groups was compared</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">87</enrollment>
  <condition>Lateral Patellar Compression Syndrome</condition>
  <arm_group>
    <arm_group_label>Lateral patellar compression syndrome</arm_group_label>
    <description>Patients diagnosed with lateral patellar compression syndrome between February 2016 and April 2019</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patellar dislocation</arm_group_label>
    <description>Patients diagnosed with patellar dislocation between February 2016 and April 2019</description>
  </arm_group>
  <arm_group>
    <arm_group_label>meniscus tear</arm_group_label>
    <description>Patients diagnosed with meniscus tear between February 2016 and April 2019</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>This is an observation study,with no intervention</description>
    <arm_group_label>Lateral patellar compression syndrome</arm_group_label>
    <arm_group_label>meniscus tear</arm_group_label>
    <arm_group_label>patellar dislocation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We enrolled 87 patients between 2016 and 2019 and divided them as per diagnosis into three&#xD;
        groups of 29 each: LPCS, patellar dislocation (PD, control), and meniscus tear (MT,&#xD;
        negative control) groups.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were diagnosed as LPCS ，MT and PD respectively&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with ligament injury, malunion of patella fracture, free bodies in the joint,&#xD;
             surgical contraindications, and with both knees affected.&#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>Yang Yu-ping</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lateral patellar compression syndrome</keyword>
  <keyword>Lateral patellar curvature angle</keyword>
  <keyword>Patellar axial radiographs</keyword>
  <keyword>The area under the curve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</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/NCT04454593
org study id: M2019464
nct id: NCT04454593
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates whether the patellar axial radiograph of lateral patellar curvature
      angle （LPCA）with knee flexion at 30 ° can be used as a new diagnostic surrogate of lateral
      patellar compression syndrome（LPCS）. We believe that the new index LPCA has high sensitivity
      and specificity in initial diagnosis of LPCS using axial patellar radiograph with knee
      flexion at 30 ° , and has high application value.
Background: A well-established reference is lacking for diagnosing lateral patellar
      compression syndrome (LPCS), and this diagnosis currently depends on clinicians' subjective
      judgment and several examination results. X-rays are primarily used to diagnose LPCS, but
      they have low detection rates of patellar tilt using the congruence angle (CA) and patellar
      tilting angle (PTA).

      Purpose: To investigate whether patellar axial radiography of the lateral patellar curvature
      angle (LPCA) of knee in 30° flexion can diagnose LPCS.

      Methods: We enrolled 87 patients between 2016 and 2019 and divided them as per diagnosis into
      three groups of 29 each: LPCS, patellar dislocation (PD, control), and meniscus tear (MT,
      negative control) groups. A senior radiologist and the chief physician of sports medicine
      examined their patellar axial radiographs of the knee in 30° flexion using a computer imaging
      system, measuring LPCA, PTA, and CA. Univariate analysis of variance and Kruskal-Wallis H
      test were used to compare measurement data with normal distribution and non-normal
      distribution, respectively. Bonferroni correction was used to analyze different indicators
      for different groups. The area under the curve (AUC) was calculated to verify the value of
      LPCA in initial diagnosis of LPCS.
observational model: Case-Control
time perspective: Retrospective
measure: lateral patellar curvature angle
time frame: between 2016 and 2019
description: lateral patellar curvature angle in three groups was compared
arm group label: Lateral patellar compression syndrome
description: Patients diagnosed with lateral patellar compression syndrome between February 2016 and April 2019
arm group label: patellar dislocation
description: Patients diagnosed with patellar dislocation between February 2016 and April 2019
arm group label: meniscus tear
description: Patients diagnosed with meniscus tear between February 2016 and April 2019
intervention type: Other
intervention name: no intervention
description: This is an observation study,with no intervention
arm group label: Lateral patellar compression syndrome
arm group label: meniscus tear
arm group label: patellar dislocation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yang Yu-ping
role: Study Chair
affiliation: Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Syndrome
sharing ipd: No