<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/NCT04456881</url>
  </required_header>
  <id_info>
    <org_study_id>2014205</org_study_id>
    <nct_id>NCT04456881</nct_id>
  </id_info>
  <brief_title>Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament</brief_title>
  <official_title>Arthroscopic Clinical Study of Double Bundle Anatomical Reconstruction of Medial Patellofemoral Ligament</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To study the clinical effect of double-beam anatomical reconstruction of medial&#xD;
      patellofemoral ligament under arthroscopy.&#xD;
&#xD;
      Methods: Double-beam anatomical reconstruction of medial patellofemoral ligament was&#xD;
      performed under arthroscopy in patients admitted to our hospital for treatment of recurrent&#xD;
      patellar dislocation. Carry out preoperative and postoperative evaluations, and conduct&#xD;
      preoperative and postoperative comparative studies to clarify the clinical effect of the&#xD;
      procedure.&#xD;
&#xD;
      Expected results: Arthroscopic double-beam anatomical reconstruction of the medial&#xD;
      patellofemoral ligament can effectively restore the stability of the patella and the motor&#xD;
      function of the knee joint.&#xD;
&#xD;
      Expected conclusion: Arthroscopic double-beam anatomical reconstruction of the medial&#xD;
      patellofemoral ligament is an effective minimally invasive technique.&#xD;
&#xD;
      Keywords: knee joint; medial patellofemoral ligament; double-beam anatomical reconstruction;&#xD;
      arthroscopy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lysholm score</measure>
    <time_frame>1 year after operation</time_frame>
    <description>The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Knee Documentation Committee (IKDC) 2000</measure>
    <time_frame>1 year after operation</time_frame>
    <description>International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tegner activity level score</measure>
    <time_frame>1 year after operation</time_frame>
    <description>The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Recurrent Patellar Dislocation</condition>
  <arm_group>
    <arm_group_label>anatomical reconstruction group of Patellofemoral ligament</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patients with patellar dislocation undergo patellar femoral medial reconstruction</intervention_name>
    <description>Arthroscopic double-beam anatomical reconstruction of medial patellofemoral ligament</description>
    <arm_group_label>anatomical reconstruction group of Patellofemoral ligament</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  17&lt;age&lt;60 years&#xD;
&#xD;
          -  Recurrent patellar dislocation or instability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Bone spurs or bone protrusions on the D-type of the femoral pulley or proximal of the&#xD;
        pulley.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ping Liu</last_name>
    <phone>13683670396</phone>
    <email>bjusmlp@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ping Liu</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 17, 2023</last_update_submitted>
  <last_update_submitted_qc>April 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>arthroscopy</keyword>
  <keyword>medial patellofemoral ligament</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellar Dislocation</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/NCT04456881
org study id: 2014205
nct id: NCT04456881
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Objective: To study the clinical effect of double-beam anatomical reconstruction of medial
      patellofemoral ligament under arthroscopy.

      Methods: Double-beam anatomical reconstruction of medial patellofemoral ligament was
      performed under arthroscopy in patients admitted to our hospital for treatment of recurrent
      patellar dislocation. Carry out preoperative and postoperative evaluations, and conduct
      preoperative and postoperative comparative studies to clarify the clinical effect of the
      procedure.

      Expected results: Arthroscopic double-beam anatomical reconstruction of the medial
      patellofemoral ligament can effectively restore the stability of the patella and the motor
      function of the knee joint.

      Expected conclusion: Arthroscopic double-beam anatomical reconstruction of the medial
      patellofemoral ligament is an effective minimally invasive technique.

      Keywords: knee joint; medial patellofemoral ligament; double-beam anatomical reconstruction;
      arthroscopy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Lysholm score
time frame: 1 year after operation
description: The Lysholm score consists of eight items including limping, locking, pain, stair climbing, use of supports, instability, swelling, and squatting. The higher values represent a better outcome.
measure: International Knee Documentation Committee (IKDC) 2000
time frame: 1 year after operation
description: International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
measure: Tegner activity level score
time frame: 1 year after operation
description: The highest level of activity that you participated in before your injury and the highest level you are able to participate in currently. The higher values represent a better outcome.
arm group label: anatomical reconstruction group of Patellofemoral ligament
arm group type: Experimental
intervention type: Other
intervention name: Patients with patellar dislocation undergo patellar femoral medial reconstruction
description: Arthroscopic double-beam anatomical reconstruction of medial patellofemoral ligament
arm group label: anatomical reconstruction group of Patellofemoral ligament
criteria: 
gender: All
minimum age: 17 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ping Liu
phone: 13683670396
email: bjusmlp@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Patellar Dislocation
sharing ipd: No