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/NCT06004297</url>
    </required_header>
    <id_info>
      <org_study_id>AP/2019/003</org_study_id>
      <nct_id>NCT06004297</nct_id>
    </id_info>
    <brief_title>Influence of Combined Double-Bundle ACL Reconstruction With Lateral Retinacular Release to Prevent Patellofemoral Malalignment in Isolated ACL Rupture</brief_title>
    <official_title>Influence of Combined Double-Bundle ACL Reconstruction With Lateral Retinacular Release to Prevent Patellofemoral Malalignment in Isolated ACL Rupture: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indonesia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indonesia 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 knee pain which might be due to patellofemoral malalignment is an inevitable post&#xD;
        operative complication after an ACL reconstruction (ACLR). We combined the double bundle ACLR&#xD;
        technique with lateral release technique to prevent patellofemoral malalignment post ACLR.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 7, 2019</start_date>
    <completion_date type="Actual">December 20, 2019</completion_date>
    <primary_completion_date type="Actual">December 20, 2019</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>TTTG value</measure>
      <time_frame>6 months</time_frame>
      <description>tibial tuberosity to trochlea groove, radiographic outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Kujala score</measure>
      <time_frame>6 months</time_frame>
      <description>functional outcome</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">100</enrollment>
    <condition>ACL Injury</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Single bundle group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Double bundle only group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Double bundle with lateral release group</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ACL reconstruction</intervention_name>
      <description>performed arthroscopically</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  unilateral isolated total ACL rupture&#xD;
  &#xD;
            -  normal BMI&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  flexion contracture more than 200, presence of anterior knee pain before surgery, Q&#xD;
               angle &gt;140 in males and &gt;170 in females, presence of a patellar tilting, rupture of&#xD;
               other ligaments, and muscular dysfunction.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Medicine Universitas Indonesia</name>
        <address>
          <city>Jakarta</city>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>Ludwig Andre Pontoh</investigator_full_name>
      <investigator_title>DR., dr., Sp.OT(K)</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rupture</mesh_term>
      <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06004297
  org study id: AP/2019/003
  nct id: NCT06004297
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Anterior knee pain which might be due to patellofemoral malalignment is an inevitable post
        operative complication after an ACL reconstruction (ACLR). We combined the double bundle ACLR
        technique with lateral release technique to prevent patellofemoral malalignment post ACLR.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: TTTG value
  time frame: 6 months
  description: tibial tuberosity to trochlea groove, radiographic outcome
  measure: Kujala score
  time frame: 6 months
  description: functional outcome
  arm group label: Group 1
  arm group type: Active Comparator
  description: Single bundle group
  arm group label: Group 2
  arm group type: Active Comparator
  description: Double bundle only group
  arm group label: Group 3
  arm group type: Experimental
  description: Double bundle with lateral release group
  intervention type: Procedure
  intervention name: ACL reconstruction
  description: performed arthroscopically
  arm group label: Group 1
  arm group label: Group 2
  arm group label: Group 3
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: Ludwig Andre Pontoh
  investigator title: DR., dr., Sp.OT(K)
  mesh term: Rupture
  mesh term: Anterior Cruciate Ligament Injuries
  sharing ipd: No