<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/NCT04454060</url>
  </required_header>
  <id_info>
    <org_study_id>M2018063</org_study_id>
    <nct_id>NCT04454060</nct_id>
  </id_info>
  <brief_title>Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow</brief_title>
  <official_title>Study on the Development of Arthroscopic Treatment of Refractory Tennis Elbow</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>
      The aim of this study was to investigate the exploration history, key theories, methods, and&#xD;
      techniques involved in the evolution from the intracapsular method to the extracapsular&#xD;
      method for arthroscopic treatment of tennis elbow, and explore the effectiveness and safety&#xD;
      of extracapsular method on the basis of retrospective analysis of 43 cases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Arthroscopic surgery is widely used in the treatment of refractory tennis elbow&#xD;
      due to its advantages of minimally invasive, safe and direct vision. Intra-capsular&#xD;
      arthroscopy(intracapsular method), which is performed via natural cavity, is the mainstream&#xD;
      arthroscopic procedure. However, intracapsular method requires the damage of joint capsule&#xD;
      and may cause intraoperative neurovascular injury and other complications. In view of the&#xD;
      defects of intracapsular method, the surgical scheme of the extracapsular arthroscopy&#xD;
      (referred to as &quot;extracapsular method&quot;) has emerged. The aim of this study was to investigate&#xD;
      the exploration history, key theories, methods, and techniques involved in the evolution from&#xD;
      the intracapsular method to the extracapsular method for arthroscopic treatment of tennis&#xD;
      elbow, and explore the effectiveness and safety of extracapsular method.&#xD;
&#xD;
      Methods: Qualitative data were collected via focus group interview. 7 surgeons who were&#xD;
      selected through purposive sampling discussed on the theories, methods, and technical&#xD;
      specifications of the transition from intracapsular method to extracapsular method.&#xD;
      Qualitative data were analysed using NVivo11. Quantitative data of consecutive 43 patients&#xD;
      were analysed to evaluate the effectiveness and safety of the extracapsular method.&#xD;
      Descriptive analysis was conducted to analyse the demographic characteristics and clinical&#xD;
      outcomes after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2018</start_date>
  <completion_date type="Actual">May 2, 2019</completion_date>
  <primary_completion_date type="Actual">November 23, 2018</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>12 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>12 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>12 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>12 months</time_frame>
    <description>Use Activity of Daily Life 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">43</enrollment>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>Extracapsular method group</arm_group_label>
    <description>consecutive 43 patients who received extracapsular method treatment for refractory tennis elbow</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 43 patients (14 men and 29 women) were reviewed. The minimum age&#xD;
        was 35 years, and the maximum age was 55 years old, with an average of 44.4 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>
    <healthy_volunteers>No</healthy_volunteers>
  </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>Qualitative</keyword>
  <keyword>Quantitative</keyword>
  <keyword>Tennis Elbow</keyword>
  <keyword>Arthroscopy</keyword>
  <keyword>Surgical Techniques</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/NCT04454060
org study id: M2018063
nct id: NCT04454060
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the exploration history, key theories, methods, and
      techniques involved in the evolution from the intracapsular method to the extracapsular
      method for arthroscopic treatment of tennis elbow, and explore the effectiveness and safety
      of extracapsular method on the basis of retrospective analysis of 43 cases.
Background: Arthroscopic surgery is widely used in the treatment of refractory tennis elbow
      due to its advantages of minimally invasive, safe and direct vision. Intra-capsular
      arthroscopy(intracapsular method), which is performed via natural cavity, is the mainstream
      arthroscopic procedure. However, intracapsular method requires the damage of joint capsule
      and may cause intraoperative neurovascular injury and other complications. In view of the
      defects of intracapsular method, the surgical scheme of the extracapsular arthroscopy
      (referred to as "extracapsular method") has emerged. The aim of this study was to investigate
      the exploration history, key theories, methods, and techniques involved in the evolution from
      the intracapsular method to the extracapsular method for arthroscopic treatment of tennis
      elbow, and explore the effectiveness and safety of extracapsular method.

      Methods: Qualitative data were collected via focus group interview. 7 surgeons who were
      selected through purposive sampling discussed on the theories, methods, and technical
      specifications of the transition from intracapsular method to extracapsular method.
      Qualitative data were analysed using NVivo11. Quantitative data of consecutive 43 patients
      were analysed to evaluate the effectiveness and safety of the extracapsular method.
      Descriptive analysis was conducted to analyse the demographic characteristics and clinical
      outcomes after surgery.
observational model: Cohort
time perspective: Retrospective
measure: Mayo Elbow Performance Score
time frame: 12 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: 12 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: 12 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: 12 months
description: Use Activity of Daily Life recovery time to evaluate the functional recovery of patients who received extracapsular arthroscopic treatment.
arm group label: Extracapsular method group
description: consecutive 43 patients who received extracapsular method treatment for refractory tennis elbow
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
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Tennis Elbow
sharing ipd: No