<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/NCT04457024</url>
  </required_header>
  <id_info>
    <org_study_id>M2019143</org_study_id>
    <nct_id>NCT04457024</nct_id>
  </id_info>
  <brief_title>Tennis Elbow Patients Undergoing Closed Therapy Can Easily Cause Tendon Tear</brief_title>
  <official_title>Tennis Elbow Patients Undergoing Closed Therapy Can Easily Cause Tendon Tear</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>
      To explore whether there is a difference in the rate of tendon tear after hyperlipemia in&#xD;
      tennis elbow patients and those with normal blood lipids after closed treatment, which&#xD;
      provides clues for further exploration of its mechanism. 1. Collect data from 108 cases of&#xD;
      tennis elbow patients treated at the Institute of Sports Medicine, Peking University Third&#xD;
      Hospital from January 2010 to December 2018 at the Institute of Sports Medicine, Peking&#xD;
      University Third Hospital. Statistics included the sex, age, BMI, number of closures, total&#xD;
      cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein. 2. Retrieve&#xD;
      the MRI imaging data of the above-mentioned patients, and use the extensor tendon at the&#xD;
      humerus to see if there is a tear as an observation indicator. Analyze the difference of&#xD;
      tendon tear after closed treatment in patients with high blood fat and normal blood fat.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Use MRI to assess whether the tendon is torn</measure>
    <time_frame>3 months</time_frame>
    <description>One sports medicine surgeon and one musculoskeletal radiologists, being blinded to the patients' information, reviewed the elbow MRI independently. The common extensor tendon (CET) abnormalities were evaluated on axial and coronal fat-suppressed T2-weighted FSE image. Tendinosis group was defined as an increased signal intensity, but lower than the fluid signal on T2-weighted images and/ or an increased tendon thickness. Tendon tear group contain a partial thickness tear defined as a region with fluid-signal-intensity that extended partway across the tendon and a full thickness tear appeared as a gap of fluid-signal-intensity across the entire tendon substance.</description>
  </primary_outcome>
  <enrollment type="Actual">108</enrollment>
  <condition>Tennis Elbow</condition>
  <condition>MRI</condition>
  <condition>Hyperlipidemia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>classification statistics</intervention_name>
    <description>Without any intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In order to rule out the influence of the imbalance between height and weight on blood&#xD;
        lipids, the difference between the case group and the control group was analyzed after&#xD;
        adjusting the height and weight covariates using the Generalized Linear Model.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with tennis elbows in our hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Peking Univerisity 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 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 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 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
    <mesh_term>Hyperlipidemias</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/NCT04457024
org study id: M2019143
nct id: NCT04457024
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To explore whether there is a difference in the rate of tendon tear after hyperlipemia in
      tennis elbow patients and those with normal blood lipids after closed treatment, which
      provides clues for further exploration of its mechanism. 1. Collect data from 108 cases of
      tennis elbow patients treated at the Institute of Sports Medicine, Peking University Third
      Hospital from January 2010 to December 2018 at the Institute of Sports Medicine, Peking
      University Third Hospital. Statistics included the sex, age, BMI, number of closures, total
      cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein. 2. Retrieve
      the MRI imaging data of the above-mentioned patients, and use the extensor tendon at the
      humerus to see if there is a tear as an observation indicator. Analyze the difference of
      tendon tear after closed treatment in patients with high blood fat and normal blood fat.
observational model: Case-Only
time perspective: Other
measure: Use MRI to assess whether the tendon is torn
time frame: 3 months
description: One sports medicine surgeon and one musculoskeletal radiologists, being blinded to the patients' information, reviewed the elbow MRI independently. The common extensor tendon (CET) abnormalities were evaluated on axial and coronal fat-suppressed T2-weighted FSE image. Tendinosis group was defined as an increased signal intensity, but lower than the fluid signal on T2-weighted images and/ or an increased tendon thickness. Tendon tear group contain a partial thickness tear defined as a region with fluid-signal-intensity that extended partway across the tendon and a full thickness tear appeared as a gap of fluid-signal-intensity across the entire tendon substance.
intervention type: Other
intervention name: classification statistics
description: Without any intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: China
responsible party type: Sponsor
mesh term: Tennis Elbow
mesh term: Hyperlipidemias
sharing ipd: No