<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/NCT04461431</url>
  </required_header>
  <id_info>
    <org_study_id>2014185</org_study_id>
    <nct_id>NCT04461431</nct_id>
  </id_info>
  <brief_title>Clinical Study of Posterolateral Structure of Knee Joint Under Arthroscopy</brief_title>
  <official_title>Clinical Study of Anatomical Reconstruction Technique of Posterolateral Structure of Knee Joint Under Arthroscopy</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>
      Objective: To study the clinical effect of anatomical reconstruction of the posterolateral&#xD;
      structure of the knee joint under arthroscopy.&#xD;
&#xD;
      Methods: The patients who were admitted to hospital for the treatment of posterolateral&#xD;
      structural injuries of the knee joint, including those with other ligament injuries (combined&#xD;
      with anterior and posterior cruciate ligament injuries and medial collateral ligament&#xD;
      injuries) were subjected to arthroscopic reconstruction of the posterolateral structures.&#xD;
      Carry out preoperative and postoperative evaluations, and conduct preoperative and&#xD;
      postoperative comparative studies to clarify the clinical effect of the procedure.&#xD;
&#xD;
      Expected results: The anatomical reconstruction technique of the posterolateral structure of&#xD;
      the knee joint under arthroscopy may effectively restore the stability and motor function of&#xD;
      the knee joint.&#xD;
&#xD;
      Expected conclusion: Arthroscopic anatomical reconstruction of the posterolateral structure&#xD;
      of the knee is an effective minimally invasive technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2020</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>KT2000</measure>
    <time_frame>1 year after operation</time_frame>
    <description>Using KT2000 to detect the backward stability of the knee joint after operation, and compare it with the healthy leg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lysholm</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>Tegner</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>
  <primary_outcome>
    <measure>IKDC</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>
  <secondary_outcome>
    <measure>MRI</measure>
    <time_frame>1 year after operation</time_frame>
    <description>Using MRI to exam the healing of the posterolateral ligament reconstructed 1 year after surgery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>the Posterolateral Structure of the Knee Joint</condition>
  <condition>Arthroscopy</condition>
  <condition>Anatomical Reconstruction</condition>
  <arm_group>
    <arm_group_label>Knee joint lateral reconstruction group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic anatomical reconstruction of the posterolateral structure of the knee</intervention_name>
    <description>Arthroscopic anatomical reconstruction of the posterolateral structure of the knee for patients with injury of the posterolateral structure of the knee</description>
    <arm_group_label>Knee joint lateral reconstruction group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &lt;70 years old&#xD;
&#xD;
          -  Those without avulsion of the affected biceps femoris tendon or iliac tibial bundle&#xD;
&#xD;
          -  Those without avulsion fracture of the fibular stop of the lateral collateral ligament&#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>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ping Liu</last_name>
    <phone>13683670396</phone>
    <email>bjusm@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>July 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04461431
org study id: 2014185
nct id: NCT04461431
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To study the clinical effect of anatomical reconstruction of the posterolateral
      structure of the knee joint under arthroscopy.

      Methods: The patients who were admitted to hospital for the treatment of posterolateral
      structural injuries of the knee joint, including those with other ligament injuries (combined
      with anterior and posterior cruciate ligament injuries and medial collateral ligament
      injuries) were subjected to arthroscopic reconstruction of the posterolateral structures.
      Carry out preoperative and postoperative evaluations, and conduct preoperative and
      postoperative comparative studies to clarify the clinical effect of the procedure.

      Expected results: The anatomical reconstruction technique of the posterolateral structure of
      the knee joint under arthroscopy may effectively restore the stability and motor function of
      the knee joint.

      Expected conclusion: Arthroscopic anatomical reconstruction of the posterolateral structure
      of the knee is an effective minimally invasive technique.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: KT2000
time frame: 1 year after operation
description: Using KT2000 to detect the backward stability of the knee joint after operation, and compare it with the healthy leg
measure: Lysholm
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: Tegner
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.
measure: IKDC
time frame: 1 year after operation
description: International Knee Documentation Committee (IKDC) 2000. The higher values represent a better outcome.
measure: MRI
time frame: 1 year after operation
description: Using MRI to exam the healing of the posterolateral ligament reconstructed 1 year after surgery
arm group label: Knee joint lateral reconstruction group
arm group type: Experimental
intervention type: Procedure
intervention name: Arthroscopic anatomical reconstruction of the posterolateral structure of the knee
description: Arthroscopic anatomical reconstruction of the posterolateral structure of the knee for patients with injury of the posterolateral structure of the knee
arm group label: Knee joint lateral reconstruction group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ping Liu
phone: 13683670396
email: bjusm@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: Undecided