<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/NCT04454047</url>
  </required_header>
  <id_info>
    <org_study_id>M2017421</org_study_id>
    <nct_id>NCT04454047</nct_id>
  </id_info>
  <brief_title>Extracapsular Arthroscopic Treatment for Refractory Tennis Elbow--Mid-and-short Term Retrospective Study of 50 Cases</brief_title>
  <official_title>Extracapsular Arthroscopic Treatment for Refractory Tennis Elbow--Mid-and-short Term Retrospective Study of 50 Cases</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 retrospectively analysed surgical outcomes of consecutive 50 cases to investigate&#xD;
      the technical standard and clinical effect of extracapsular arthroscopic treatment for&#xD;
      refractory tennis elbow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate the technical standard of extracapsular arthroscopic treatment for refractory&#xD;
      tennis elbow. Consecutive 50 cases of refractory tennis elbow from 50 patients who underwent&#xD;
      extracapsular arthroscopic surgery which performed independently by the same doctor from&#xD;
      March 2012 to November 2016 was retrospectively analyzed. The key points of technical&#xD;
      standard were summarized, including debridement, decortication and microfracture, suture&#xD;
      under arthroscopy and postoperative cast fixation. Visual Analogue Scale(VAS), Mayo elbow&#xD;
      performance score and Disability of Arm, Shoulder, and Hand outcome measure (DASH) were&#xD;
      evaluated for postoperative results. The effects of various technical points were analyzed by&#xD;
      rank sum test, independent sample t test, χ2 test and multiple logistic regression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2017</start_date>
  <completion_date type="Actual">June 26, 2018</completion_date>
  <primary_completion_date type="Actual">November 15, 2017</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>Mayo Elbow Performance Score</measure>
    <time_frame>24 months</time_frame>
    <description>Use Mayo Elbow Performance Score（MEPS） to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment. MEPS ranges from 0 to 100, higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>24 months</time_frame>
    <description>Use Visual Analog Scale(VAS) to evaluate the pain recovery of patients who received extracapsular arthroscopic treatment. VAS ranges from 0 to 10, higher scores mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability of Arm, Shoulder and Hand score</measure>
    <time_frame>24 months</time_frame>
    <description>Use Disability of Arm, Shoulder and Hand(DASH) score to evaluate the functional and pain recovery of patients who received extracapsular arthroscopic treatment. DASH ranges from 0 to 100, higher scores mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activity of Daily Life recovery time</measure>
    <time_frame>24 months</time_frame>
    <description>Use Activity of Daily Life(ADL) recovery time to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>Extracapsular method group</arm_group_label>
    <description>50 patients with refractory tennis elbow who received extracapsular arthroscopic surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Extracapsular arthroscopy</intervention_name>
    <description>Extracapsular arthroscopy method was used to treat refractory tennis elbow</description>
    <arm_group_label>Extracapsular method group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The quantitative data of 50 patients (20 men and 30 women) were reviewed. The minimum age&#xD;
        was 35 years, and the maximum age was 55 years old, with an average of 44.6 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis was refractory tennis elbow;&#xD;
&#xD;
          2. Standard extracapsular method was used for surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient had past history of joint infection, joint tuberculosis, or osteomyelitis, or&#xD;
             the upper limb had undergone surgery within the past 6 months;&#xD;
&#xD;
          2. Diagnosis was combined with severe heart, brain, kidney, or another organ dysfunction;&#xD;
&#xD;
          3. Case was complicated with other serious elbow joint diseases or injuries;&#xD;
&#xD;
          4. Patient did not sign the informed consent form.&#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 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>Refractory tennis elbow</keyword>
  <keyword>Arthroscopy</keyword>
  <keyword>Intracapsular method</keyword>
  <keyword>Extracapsular method</keyword>
  <keyword>Surgical technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</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/NCT04454047
org study id: M2017421
nct id: NCT04454047
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study retrospectively analysed surgical outcomes of consecutive 50 cases to investigate
      the technical standard and clinical effect of extracapsular arthroscopic treatment for
      refractory tennis elbow.
To investigate the technical standard of extracapsular arthroscopic treatment for refractory
      tennis elbow. Consecutive 50 cases of refractory tennis elbow from 50 patients who underwent
      extracapsular arthroscopic surgery which performed independently by the same doctor from
      March 2012 to November 2016 was retrospectively analyzed. The key points of technical
      standard were summarized, including debridement, decortication and microfracture, suture
      under arthroscopy and postoperative cast fixation. Visual Analogue Scale(VAS), Mayo elbow
      performance score and Disability of Arm, Shoulder, and Hand outcome measure (DASH) were
      evaluated for postoperative results. The effects of various technical points were analyzed by
      rank sum test, independent sample t test, χ2 test and multiple logistic regression.
observational model: Cohort
time perspective: Retrospective
measure: Mayo Elbow Performance Score
time frame: 24 months
description: Use Mayo Elbow Performance Score（MEPS） to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment. MEPS ranges from 0 to 100, higher scores mean a better outcome.
measure: Visual Analog Scale
time frame: 24 months
description: Use Visual Analog Scale(VAS) to evaluate the pain recovery of patients who received extracapsular arthroscopic treatment. VAS ranges from 0 to 10, higher scores mean a worse outcome.
measure: Disability of Arm, Shoulder and Hand score
time frame: 24 months
description: Use Disability of Arm, Shoulder and Hand(DASH) score to evaluate the functional and pain recovery of patients who received extracapsular arthroscopic treatment. DASH ranges from 0 to 100, higher scores mean a worse outcome.
measure: Activity of Daily Life recovery time
time frame: 24 months
description: Use Activity of Daily Life(ADL) recovery time to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment.
arm group label: Extracapsular method group
description: 50 patients with refractory tennis elbow who received extracapsular arthroscopic surgery.
intervention type: Procedure
intervention name: Extracapsular arthroscopy
description: Extracapsular arthroscopy method was used to treat refractory tennis elbow
arm group label: Extracapsular method group
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
sharing ipd: No