<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/NCT01719666</url>
  </required_header>
  <id_info>
    <org_study_id>2010.651</org_study_id>
    <nct_id>NCT01719666</nct_id>
  </id_info>
  <brief_title>Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release</brief_title>
  <official_title>Randomized Control Trial on Lateral Retinaculum Release in MPFL Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesis is lateral retinaculum release has no effect on treatment of&#xD;
      Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 22, 2011</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2024</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patellar tilt measurement</measure>
    <time_frame>2 years of follow up</time_frame>
    <description>IKDC score, patellar tilt measurement on x-rays and CT-scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of complications</measure>
    <time_frame>2 years of follow up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Episodic Patellar Dislocation</condition>
  <arm_group>
    <arm_group_label>isolated MPFL reconstruction</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MPFL reconstruction and Lateral retinaculum release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MPFL reconstruction and lateral retinaculum release</intervention_name>
    <description>MPFL is performed with a standard technique using gracilis tendon. A tunnel is performed at the femoral part with a bioabsorbable screw fixation and 2 bundles with suture fixation at the patellar side</description>
    <arm_group_label>MPFL reconstruction and Lateral retinaculum release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional surgery</intervention_name>
    <description>conventional surgery: MPFL reconstruction</description>
    <arm_group_label>isolated MPFL reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18yo and 45yo&#xD;
&#xD;
          -  indication for MPFL reconstruction&#xD;
&#xD;
          -  unilateral or bilateral indication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  indication for bony procedures&#xD;
&#xD;
          -  previous surgery for PF disorders&#xD;
&#xD;
          -  patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Croix-Rousse Hospital, Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 22, 2011</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MPFL</keyword>
  <keyword>patella</keyword>
  <keyword>dislocation</keyword>
  <keyword>release</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Patellar Dislocation</mesh_term>
  </condition_browse>
  <!-- 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/NCT01719666
org study id: 2010.651
nct id: NCT01719666
lead sponsor: 
has dmc: No
The investigators hypothesis is lateral retinaculum release has no effect on treatment of
      Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patellar tilt measurement
time frame: 2 years of follow up
description: IKDC score, patellar tilt measurement on x-rays and CT-scan
measure: rate of complications
time frame: 2 years of follow up
arm group label: isolated MPFL reconstruction
arm group type: Other
arm group label: MPFL reconstruction and Lateral retinaculum release
arm group type: Experimental
intervention type: Procedure
intervention name: MPFL reconstruction and lateral retinaculum release
description: MPFL is performed with a standard technique using gracilis tendon. A tunnel is performed at the femoral part with a bioabsorbable screw fixation and 2 bundles with suture fixation at the patellar side
arm group label: MPFL reconstruction and Lateral retinaculum release
intervention type: Procedure
intervention name: conventional surgery
description: conventional surgery: MPFL reconstruction
arm group label: isolated MPFL reconstruction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Patellar Dislocation