xml: <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/NCT05962580</url>
    </required_header>
    <id_info>
      <org_study_id>MD 13/2021</org_study_id>
      <nct_id>NCT05962580</nct_id>
    </id_info>
    <brief_title>Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Among High Demand Patients</brief_title>
    <official_title>of Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Between High Demand Patients: Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</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>
        Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis&#xD;
        between high demand patients&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It is a randomized control trial comparing between isolated anterior cruciate ligament&#xD;
        reconstruction with and without lateral extra articular tenodesis between high demand and&#xD;
        high risk groups with high pivot regarding failure rate (primary out come) and patient&#xD;
        reported functions score (IKDC and Lysholm)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 15, 2021</start_date>
    <completion_date type="Actual">March 1, 2023</completion_date>
    <primary_completion_date type="Actual">February 15, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>failure rate</measure>
      <time_frame>one year follow up</time_frame>
      <description>retear of ACL graft confirmed by clinical examination and MRI</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>International knee documentation committee score (IKDC)</measure>
      <time_frame>at 3,6,9,12 months</time_frame>
      <description>The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lysholm score</measure>
      <time_frame>at 3,6,9,12 months</time_frame>
      <description>The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Physicians use this condition-specific, subjective outcome score to assess patient progress after surgery or injury to the knee. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>antero-posterior instability measure</measure>
      <time_frame>at 3,6,9 and 12 months</time_frame>
      <description>measure AP instability by KT1000 lachmeter for injured and non injured knee</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>side to side KT 1000 lachmeter difference</measure>
      <time_frame>one year follow up</time_frame>
      <description>measure side to side KT 1000 lachmeter difference by (injured - noninjured)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Anterior Cruciate Ligament Tear</condition>
    <arm_group>
      <arm_group_label>Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis</intervention_name>
      <description>Anatomical single bundle ACLR with modified Lemiere technique</description>
      <arm_group_label>Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Isolated anterior cruciate ligament reconstruction only</intervention_name>
      <description>arthroscopic anatomical single bundle ACL Reconstruction</description>
      <arm_group_label>Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  High demand patients (manual workers, athletes,...etc.).&#xD;
  &#xD;
            -  Normal average body mass index ( 18.5 - 24.9 ).&#xD;
  &#xD;
            -  Age &lt;40 years old.&#xD;
  &#xD;
            -  Patients will be diagnosed as ACL tear by the following:&#xD;
  &#xD;
                 1. History of knee traumatic event.&#xD;
  &#xD;
                 2. Clinical examination ( positive Lachman test and pivot shift test).&#xD;
  &#xD;
                 3. Radiological evidence of ACL tear by MRI.&#xD;
  &#xD;
            -  patient with high pivot shift test.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Generalized ligamentous laxity.&#xD;
  &#xD;
            -  Other intra or extra articular knee injuries.&#xD;
  &#xD;
            -  Previous ACL surgery on the affected knee.&#xD;
  &#xD;
            -  Bilateral ACL injuries.&#xD;
  &#xD;
            -  Significant Articular surface injury.&#xD;
  &#xD;
            -  Medical comorbidities&#xD;
  &#xD;
            -  Patients with malalignment ( genu varum, genu valgum or genu recurvatum )&#xD;
  &#xD;
            -  Neuromuscular disorders&#xD;
  &#xD;
            -  Knee arthritic changes.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amr Mo Abdelhady, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Faculty of medecine, Ain shams university</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mohamed Ha Sobhey, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Faculty of medecine, Ain shams university</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Moustapha Al ElAbd, lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Faculty of medecine, Ain shams university</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yehia Mo Haroun, Lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Faculty of medecine, Ain shams university</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmed Ab Amer, Msc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of medecine, Ain shams university</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ahmed Abdel Salam Abdel Halim</name>
        <address>
          <city>Cairo</city>
          <state>Abbasia</state>
          <zip>11539</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>anterior cruciate ligament tear</keyword>
    <keyword>anterolateral instability</keyword>
    <keyword>retear</keyword>
    <keyword>extra articular tenodesis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962580
  org study id: MD 13/2021
  nct id: NCT05962580
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis
        between high demand patients
  It is a randomized control trial comparing between isolated anterior cruciate ligament
        reconstruction with and without lateral extra articular tenodesis between high demand and
        high risk groups with high pivot regarding failure rate (primary out come) and patient
        reported functions score (IKDC and Lysholm)
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: failure rate
  time frame: one year follow up
  description: retear of ACL graft confirmed by clinical examination and MRI
  measure: International knee documentation committee score (IKDC)
  time frame: at 3,6,9,12 months
  description: The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
  measure: Lysholm score
  time frame: at 3,6,9,12 months
  description: The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Physicians use this condition-specific, subjective outcome score to assess patient progress after surgery or injury to the knee. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
  measure: antero-posterior instability measure
  time frame: at 3,6,9 and 12 months
  description: measure AP instability by KT1000 lachmeter for injured and non injured knee
  measure: side to side KT 1000 lachmeter difference
  time frame: one year follow up
  description: measure side to side KT 1000 lachmeter difference by (injured - noninjured)
  arm group label: Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis
  arm group type: Experimental
  description: Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis
  arm group label: Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis
  arm group type: Active Comparator
  description: Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only
  intervention type: Procedure
  intervention name: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis
  description: Anatomical single bundle ACLR with modified Lemiere technique
  arm group label: Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis
  intervention type: Procedure
  intervention name: Isolated anterior cruciate ligament reconstruction only
  description: arthroscopic anatomical single bundle ACL Reconstruction
  arm group label: Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Amr Mo Abdelhady, Professor
  role: Study Chair
  affiliation: Faculty of medecine, Ain shams university
  last name: Mohamed Ha Sobhey, Professor
  role: Study Director
  affiliation: Faculty of medecine, Ain shams university
  last name: Moustapha Al ElAbd, lecturer
  role: Study Director
  affiliation: Faculty of medecine, Ain shams university
  last name: Yehia Mo Haroun, Lecturer
  role: Study Director
  affiliation: Faculty of medecine, Ain shams university
  last name: Ahmed Ab Amer, Msc
  role: Principal Investigator
  affiliation: Faculty of medecine, Ain shams university
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Anterior Cruciate Ligament Injuries