<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/NCT04467775</url>
  </required_header>
  <id_info>
    <org_study_id>7624</org_study_id>
    <nct_id>NCT04467775</nct_id>
  </id_info>
  <brief_title>Sagittal Balance Through Ages</brief_title>
  <acronym>ESTA</acronym>
  <official_title>Sagittal Balance Through Ages</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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 parameters of the sagittal balance of the cervical, thoracic and lumbar spine vary&#xD;
      according to the types of spino-pelvic organization (types 1-4 according to Roussouly). These&#xD;
      parameters have been described as a function of age in previous scientific work without&#xD;
      taking into account the pelvic anatomy (pelvic incidence and spino-pelvic organization). This&#xD;
      work, carried out within the framework of a round table of the French Society of Spinal&#xD;
      Surgery (SFCR), would make it possible to provide a more detailed repository of existing&#xD;
      radiographic parameters.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2020</start_date>
  <completion_date type="Actual">October 2, 2020</completion_date>
  <primary_completion_date type="Actual">October 2, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Retrospective study of the radiographic parameters measured by the KEOPS software</measure>
    <time_frame>files analysed retrospectily from from January 1, 2014 to December 31, 2019 will be examined</time_frame>
  </primary_outcome>
  <enrollment type="Actual">2000</enrollment>
  <condition>Spinal Deformity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subject having carried out a telecolonne or EOS type X-ray for spinal balance (low back&#xD;
        pain, sciatica, cervico-brachial neuralgia, inequality of length of the lower limbs) in&#xD;
        spinal surgery consultation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Minor or major subject aged 5 to 100&#xD;
&#xD;
          -  Subject having carried out a telecolonne or EOS type X-ray for spinal balance (low&#xD;
             back pain, sciatica, cervico-brachial neuralgia, inequality of length of the lower&#xD;
             limbs) in spinal surgery consultation&#xD;
&#xD;
          -  Subject not having expressed its opposition, after information, to the re-use of its&#xD;
             data for the purposes of this research.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Subject with surgical history, fractures, osteoporotic packing, vertebral deformation&#xD;
             (scoliosis, kyphosis, spondylolisthesis grades 2-5), vertebral osteolysis&#xD;
             (spondylodiscitis, tumor or metastasis).&#xD;
&#xD;
          -  Subject who expressed his opposition to participate in the study&#xD;
&#xD;
          -  Subject under guardianship or curatorship&#xD;
&#xD;
          -  Subject under judicial protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service de Chirurgie du Rachis</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal Deformity</keyword>
  <keyword>Low back pain</keyword>
  <keyword>Sciatica</keyword>
  <keyword>Cervico brachial neuralgia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</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/NCT04467775
org study id: 7624
nct id: NCT04467775
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The parameters of the sagittal balance of the cervical, thoracic and lumbar spine vary
      according to the types of spino-pelvic organization (types 1-4 according to Roussouly). These
      parameters have been described as a function of age in previous scientific work without
      taking into account the pelvic anatomy (pelvic incidence and spino-pelvic organization). This
      work, carried out within the framework of a round table of the French Society of Spinal
      Surgery (SFCR), would make it possible to provide a more detailed repository of existing
      radiographic parameters.
observational model: Case-Only
time perspective: Retrospective
measure: Retrospective study of the radiographic parameters measured by the KEOPS software
time frame: files analysed retrospectily from from January 1, 2014 to December 31, 2019 will be examined
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Congenital Abnormalities