<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/NCT03772119</url>
  </required_header>
  <id_info>
    <org_study_id>RIPH3-RNI17/HEMIVERTEBRE SOFOP</org_study_id>
    <nct_id>NCT03772119</nct_id>
  </id_info>
  <brief_title>Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children</brief_title>
  <official_title>Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</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>
      The treatment of child's vertebral malformations has evolved a lot including the realization&#xD;
      of surgical vertebral resections. The surgical techniques used are multiple, require heavy&#xD;
      surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to&#xD;
      20% in some series, risk of non-consolidation, insufficient correction). These surgical&#xD;
      techniques deserve an evaluation of the early complications and the skeletal maturity of&#xD;
      these children (maintenance of the surgical correction, evolution of the associated&#xD;
      curvatures).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment of child's vertebral malformations has evolved a lot including the realization&#xD;
      of surgical vertebral resections. The surgical techniques used are multiple, require heavy&#xD;
      surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to&#xD;
      20% in some series, risk of non-consolidation, insufficient correction). These surgical&#xD;
      techniques deserve an evaluation of the early complications and the skeletal maturity of&#xD;
      these children (maintenance of the surgical correction, evolution of the associated&#xD;
      curvatures).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">February 2039</completion_date>
  <primary_completion_date type="Anticipated">February 2039</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>15 Years</target_duration>
  <primary_outcome>
    <measure>Immediate effectiveness of surgery: Evolution of Cobb angle</measure>
    <time_frame>From baseline to 6 months after surgery</time_frame>
    <description>Effectiveness of immediate correction : spinal deformities measured by the Cobb angle on radios face and profile</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Appearances of complications</measure>
    <time_frame>From baseline to 6 months after surgery</time_frame>
    <description>Appearances of complications (neurological, vascular, non consolidation) at 6 months. These complications will be gathered from hospitalization reports.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Late persistence of complications</measure>
    <time_frame>From 6 months after surgery to 15 years</time_frame>
    <description>Persistent complications will be collected through clinical examination at follow-up visits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Long-term effectiveness of surgery: Evolution of Cobb angle</measure>
    <time_frame>From 6 months after surgery to 15 years</time_frame>
    <description>Maintaining local correction with growth: spinal deformities measured by the Cobb angle on radios face and profile</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Hemivertebra</condition>
  <arm_group>
    <arm_group_label>Surgical treatment of hemivertebra</arm_group_label>
    <description>cohort of children with a vertebral malformation treated by surgical resection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical resection</intervention_name>
    <description>Surgical resection of hemivertebra</description>
    <arm_group_label>Surgical treatment of hemivertebra</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        children from 3 to 10 years old with vertebral malformation requiring surgery for&#xD;
        hemivertebra&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child from 3 to 10 years old&#xD;
&#xD;
          -  with a vertebral malformation requiring surgery for hemivertebras&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child previously operated on the spine&#xD;
&#xD;
          -  Different procedure of a surgical resection of vertebral malformation&#xD;
&#xD;
          -  Absence of medical follow-up&#xD;
&#xD;
          -  Parents refusal concerning data storage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thierry ODENT, MD-PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospttal, Tours</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thierry ODENT, MD-PhD</last_name>
    <phone>02 47 47 38 22</phone>
    <phone_ext>+33</phone_ext>
    <email>T.ODENT@chu-tours.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan LEFEVRE, MD-PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aurélien COURVOISIER, MD-PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Thierry HAUMONT, MD-PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Vincent CUNIN, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sébastien PESENTI, MD-PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine HAMEL, MD-PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Nice</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Federico SOLLA, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raphael VIALLE, MD-PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, Robert-Debré Hospital, AP-HP</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brice ILHARREBORDE, MD-PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Keyvan MAZDA, MD-PhD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP</name>
      <address>
        <city>Paris</city>
        <zip>75730</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lofti MILADI, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35203</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe VIOLAS, MD-PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elie HADDAD, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Bruno DOHIN, MD-PhD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franck ACCADBLED, MD-PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery Service, University Hospital, Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thierry ODent, MD-PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>October 10, 2022</last_update_submitted>
  <last_update_submitted_qc>October 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vertebral Malformation</keyword>
  <keyword>Hemivertebra</keyword>
  <keyword>Surgical resection</keyword>
  <keyword>SOFOP</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03772119
org study id: RIPH3-RNI17/HEMIVERTEBRE SOFOP
nct id: NCT03772119
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The treatment of child's vertebral malformations has evolved a lot including the realization
      of surgical vertebral resections. The surgical techniques used are multiple, require heavy
      surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to
      20% in some series, risk of non-consolidation, insufficient correction). These surgical
      techniques deserve an evaluation of the early complications and the skeletal maturity of
      these children (maintenance of the surgical correction, evolution of the associated
      curvatures).
The treatment of child's vertebral malformations has evolved a lot including the realization
      of surgical vertebral resections. The surgical techniques used are multiple, require heavy
      surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to
      20% in some series, risk of non-consolidation, insufficient correction). These surgical
      techniques deserve an evaluation of the early complications and the skeletal maturity of
      these children (maintenance of the surgical correction, evolution of the associated
      curvatures).
observational model: Cohort
time perspective: Prospective
measure: Immediate effectiveness of surgery: Evolution of Cobb angle
time frame: From baseline to 6 months after surgery
description: Effectiveness of immediate correction : spinal deformities measured by the Cobb angle on radios face and profile
measure: Appearances of complications
time frame: From baseline to 6 months after surgery
description: Appearances of complications (neurological, vascular, non consolidation) at 6 months. These complications will be gathered from hospitalization reports.
measure: Late persistence of complications
time frame: From 6 months after surgery to 15 years
description: Persistent complications will be collected through clinical examination at follow-up visits.
measure: Long-term effectiveness of surgery: Evolution of Cobb angle
time frame: From 6 months after surgery to 15 years
description: Maintaining local correction with growth: spinal deformities measured by the Cobb angle on radios face and profile
arm group label: Surgical treatment of hemivertebra
description: cohort of children with a vertebral malformation treated by surgical resection
intervention type: Procedure
intervention name: Surgical resection
description: Surgical resection of hemivertebra
arm group label: Surgical treatment of hemivertebra
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
healthy volunteers: No
last name: Thierry ODENT, MD-PhD
role: Study Director
affiliation: University Hospttal, Tours
last name: Thierry ODENT, MD-PhD
phone: 02 47 47 38 22
phone ext: +33
email: T.ODENT@chu-tours.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: No