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/NCT06024850</url>
    </required_header>
    <id_info>
      <org_study_id>IRBN342022/CHUSTE</org_study_id>
      <nct_id>NCT06024850</nct_id>
    </id_info>
    <brief_title>Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)</brief_title>
    <official_title>Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Saint Etienne</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>
        Multiligamentar knee injury has consequences on knee function (instability, arthritis, life&#xD;
        disagreement). Surgical reconstructions have known recent evolutions. The goal of this study&#xD;
        is to evaluate functional and clinical results at one year of those new surgical technics. A&#xD;
        clinical and functional follow up will be performed before the surgery, then at 6 months and&#xD;
        one year.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients will also benefit of a Magnetic Resonance Imaging (MRI) and isokinetic evaluations&#xD;
        at one year.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Functional score : International Knee Documentation Committee (IKDC)</measure>
      <time_frame>Months : 0, 6 and 12</time_frame>
      <description>The International Knee Documentation Committee (IKDC) is a questionnaire that assigns patients an overall functional score. Three categories are examined by the questionnaire: symptoms, sports activity and knee function, on a scale of 0 to 100.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Functional score : Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
      <time_frame>Months : 0, 6 and 12</time_frame>
      <description>The Knee Injury and Osteoarthritis Outcome Score (KOOS) is used to assess immediate and long-term patient outcomes after knee injury. Five outcomes are assessed by the self-administered KOOS: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life, on a scale of 0 to 100.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale (VAS) scale</measure>
      <time_frame>Months: 0, 6 and 12</time_frame>
      <description>Analysis of the Visual Analogue Scale (VAS) scale (from 0 to 10, 10 = pain ++)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Laxity</measure>
      <time_frame>Month : 12</time_frame>
      <description>Laxity assessed by Magnetic Resonance Imaging (MRI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Joint amplitudes</measure>
      <time_frame>Months: 0, 6 and 12</time_frame>
      <description>Joint amplitudes assessed by the iso-cinetic test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical data</measure>
      <time_frame>Month : 0</time_frame>
      <description>Data collected at inclusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recovery of muscle function</measure>
      <time_frame>Month : 12</time_frame>
      <description>Recovery of muscle function measured by iso kinetic muscle assessment</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Knee Ligament Injury</condition>
    <arm_group>
      <arm_group_label>multiligamentar knee reconstruction</arm_group_label>
      <description>Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne will be included.&#xD;
  Datas collected by medical record.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Datas collected</intervention_name>
      <description>Datas collected by medical record: medical data (weight, height, smoking status, history) and socio-demographic data (age, occupation, type of injury) information, assessment of knee function before surgery, at 6 months and 1 year after surgery, magnetic resonance imaging (MRI) and radiological imaging at 1 year after surgery, results of the Iso-kinetic Muscle Assessment Test at 1 year after surgery to objectively determine the recovery of muscle function&#xD;
  The data collected will be used to perform a statistical analysis to evaluate the factors predicting a good long-term post-surgical evolution</description>
      <arm_group_label>multiligamentar knee reconstruction</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Any patient who benefits of a multiligamentar knee reconstruction at hospital of&#xD;
          Saint-Etienne will be included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Any patient who benefits of a multiligamentar knee reconstruction at hospital of&#xD;
               Saint-Etienne&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Thomas NERI, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Saint-Etienne</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Thomas NERI, MD PhD</last_name>
      <phone>(0)477127549</phone>
      <phone_ext>+33</phone_ext>
      <email>Thomas.Neri@chu-st-etienne.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pierre-Henri VERMOREL, resident</last_name>
      <phone>(0)477127549</phone>
      <phone_ext>+33</phone_ext>
      <email>vermoph@hotmail.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU Saint-Etienne</name>
        <address>
          <city>Saint-Étienne</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Thomas NERI, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pierre-Henri VERMOREL, resident</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Multiligamentar</keyword>
    <keyword>injury</keyword>
    <keyword>knee</keyword>
    <keyword>magnetic resonance imaging (MRI)</keyword>
    <keyword>knee reconstruction</keyword>
    <keyword>knee dislocation</keyword>
    <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/NCT06024850
  org study id: IRBN342022/CHUSTE
  nct id: NCT06024850
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Multiligamentar knee injury has consequences on knee function (instability, arthritis, life
        disagreement). Surgical reconstructions have known recent evolutions. The goal of this study
        is to evaluate functional and clinical results at one year of those new surgical technics. A
        clinical and functional follow up will be performed before the surgery, then at 6 months and
        one year.
  Patients will also benefit of a Magnetic Resonance Imaging (MRI) and isokinetic evaluations
        at one year.
  observational model: Cohort
  time perspective: Prospective
  measure: Functional score : International Knee Documentation Committee (IKDC)
  time frame: Months : 0, 6 and 12
  description: The International Knee Documentation Committee (IKDC) is a questionnaire that assigns patients an overall functional score. Three categories are examined by the questionnaire: symptoms, sports activity and knee function, on a scale of 0 to 100.
  measure: Functional score : Knee Injury and Osteoarthritis Outcome Score (KOOS)
  time frame: Months : 0, 6 and 12
  description: The Knee Injury and Osteoarthritis Outcome Score (KOOS) is used to assess immediate and long-term patient outcomes after knee injury. Five outcomes are assessed by the self-administered KOOS: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life, on a scale of 0 to 100.
  measure: Visual Analogue Scale (VAS) scale
  time frame: Months: 0, 6 and 12
  description: Analysis of the Visual Analogue Scale (VAS) scale (from 0 to 10, 10 = pain ++)
  measure: Laxity
  time frame: Month : 12
  description: Laxity assessed by Magnetic Resonance Imaging (MRI)
  measure: Joint amplitudes
  time frame: Months: 0, 6 and 12
  description: Joint amplitudes assessed by the iso-cinetic test
  measure: Clinical data
  time frame: Month : 0
  description: Data collected at inclusion
  measure: Recovery of muscle function
  time frame: Month : 12
  description: Recovery of muscle function measured by iso kinetic muscle assessment
  arm group label: multiligamentar knee reconstruction
  description: Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne will be included.
  Datas collected by medical record.
  intervention type: Other
  intervention name: Datas collected
  description: Datas collected by medical record: medical data (weight, height, smoking status, history) and socio-demographic data (age, occupation, type of injury) information, assessment of knee function before surgery, at 6 months and 1 year after surgery, magnetic resonance imaging (MRI) and radiological imaging at 1 year after surgery, results of the Iso-kinetic Muscle Assessment Test at 1 year after surgery to objectively determine the recovery of muscle function
  The data collected will be used to perform a statistical analysis to evaluate the factors predicting a good long-term post-surgical evolution
  arm group label: multiligamentar knee reconstruction
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Thomas NERI, MD PhD
  role: Principal Investigator
  affiliation: CHU Saint-Etienne
  last name: Thomas NERI, MD PhD
  phone: (0)477127549
  phone ext: +33
  email: Thomas.Neri@chu-st-etienne.fr
  last name: Pierre-Henri VERMOREL, resident
  phone: (0)477127549
  phone ext: +33
  email: vermoph@hotmail.fr
  facility: 
  status: Recruiting
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  sharing ipd: No