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/NCT05987150</url>
    </required_header>
    <id_info>
      <org_study_id>2021-398-01</org_study_id>
      <nct_id>NCT05987150</nct_id>
    </id_info>
    <brief_title>Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis</brief_title>
    <official_title>Variation in Anisotropy of the Spinal Cord Around Apical Region in Patients With Hyperkyphosis: A Pilot Study Using Diffusion Tensor Imaging</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</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>
        Spinal cord compression is commonly seen in patients with severe kyphosis. However,&#xD;
        conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in&#xD;
        microstructural integrity of the spinal cord around the apical vertebrae in these patients.&#xD;
        The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord&#xD;
        around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Spinal cord compression is commonly seen in patients with severe kyphosis. However,&#xD;
        conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in&#xD;
        microstructural integrity of the spinal cord around the apical vertebrae in these patients.&#xD;
        The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord&#xD;
        around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).&#xD;
  &#xD;
        Twenty-four patients with hyperkyphosis aged 46.1±22.8 years who underwent 3.0T MRI&#xD;
        examination with DTI sequence were prospectively enrolled from July 2022 to January 2023.&#xD;
        Patients were divided into three groups according to spinal cord/cerebrospinal fluid&#xD;
        architecture (CSF) on sagittal-T2 MRI of the thoracic apex: Type A-circular cord with visible&#xD;
        CSF, Type B-circular cord but no visible CSF at apical dorsal, and Type C-spinal cord&#xD;
        deformed without intervening CSF. The Fractional Anisotropy (FA) values acquired from DTI&#xD;
        were compared among different groups. Correlations between DTI parameters and global kyphosis&#xD;
        (GK)/sagittal deformity angular ratio (SDAR) were evaluated using Pearson correlation&#xD;
        coefficients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Actual">April 30, 2023</completion_date>
    <primary_completion_date type="Actual">January 31, 2023</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>Fractional anisotropy (FA) values</measure>
      <time_frame>preoperative</time_frame>
      <description>Raw DTI data were postprocessed on FuncTool (GE) software. After an initial correction of geometric distortions, the color-coded FA maps were generated.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Global kyphosis (GK) in degrees</measure>
      <time_frame>preoperative</time_frame>
      <description>Measured on anteroposterior and lateral radiographs and defined as the angle from upper to lower most tilted end vertebrae.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sagittal deformity angular ratio (SDAR)</measure>
      <time_frame>preoperative</time_frame>
      <description>Divided GK by the number of levels spanning the curve.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">24</enrollment>
    <condition>Hyperkyphosis</condition>
    <arm_group>
      <arm_group_label>Type A</arm_group_label>
      <description>Type A was defined as a round/oval spinal cord shape with visible cerebrospinal fluid (CSF) between the cord and the apical vertebrae.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Type B</arm_group_label>
      <description>Type B was defined as a round/oval spinal cord shape with no CSF between the apical vertebrae and spinal cord.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Type C</arm_group_label>
      <description>Type C cord was defined as a spinal cord that is fattened/deformed by the vertebral body, with no visible CSF between the apex and the cord.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Variation in anisotropy of the Spinal Cord using diffusion tensor imaging</intervention_name>
      <description>All examinations were performed on a 3.0-T MRI machine with a 12-channel spine special coil (Ingenia CX, Philips Healthcare, Best, the Netherlands). The multi-sequence MRI protocol included conventional T1-weighted (sag &amp; tra), T2-weighted (sag &amp; tra), and DTI sequence.</description>
      <arm_group_label>Type A</arm_group_label>
      <arm_group_label>Type B</arm_group_label>
      <arm_group_label>Type C</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          24 patients with hyperkyphosis aged 46.1±22.8 years who underwent 3.0T magnetic resonance&#xD;
          imaging (MRI) examination with DTI sequence were prospectively enrolled.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of hyperkyphosis;&#xD;
  &#xD;
            -  the apex located at the thoracal region (T1-T12);&#xD;
  &#xD;
            -  full DTI data;&#xD;
  &#xD;
            -  records of detailed and systematic neurological physical examination.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  any case with active infection, tumor, or trauma;&#xD;
  &#xD;
            -  any cases of comorbidity of neurofibromatosis type I;&#xD;
  &#xD;
            -  any cases combined with spinal syringomyelia, split cord malformations or&#xD;
               diastematomyelia, tethered cord syndrome;&#xD;
  &#xD;
            -  previous spinal surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>78 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Drum Tower Hospital of Nanjing University Medical School</name>
        <address>
          <city>Nanjing</city>
          <state>Jiang Su</state>
          <zip>210000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kyphosis</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/NCT05987150
  org study id: 2021-398-01
  nct id: NCT05987150
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Spinal cord compression is commonly seen in patients with severe kyphosis. However,
        conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in
        microstructural integrity of the spinal cord around the apical vertebrae in these patients.
        The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord
        around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).
  Spinal cord compression is commonly seen in patients with severe kyphosis. However,
        conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in
        microstructural integrity of the spinal cord around the apical vertebrae in these patients.
        The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord
        around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).
  
        Twenty-four patients with hyperkyphosis aged 46.1±22.8 years who underwent 3.0T MRI
        examination with DTI sequence were prospectively enrolled from July 2022 to January 2023.
        Patients were divided into three groups according to spinal cord/cerebrospinal fluid
        architecture (CSF) on sagittal-T2 MRI of the thoracic apex: Type A-circular cord with visible
        CSF, Type B-circular cord but no visible CSF at apical dorsal, and Type C-spinal cord
        deformed without intervening CSF. The Fractional Anisotropy (FA) values acquired from DTI
        were compared among different groups. Correlations between DTI parameters and global kyphosis
        (GK)/sagittal deformity angular ratio (SDAR) were evaluated using Pearson correlation
        coefficients.
  observational model: Cohort
  time perspective: Prospective
  measure: Fractional anisotropy (FA) values
  time frame: preoperative
  description: Raw DTI data were postprocessed on FuncTool (GE) software. After an initial correction of geometric distortions, the color-coded FA maps were generated.
  measure: Global kyphosis (GK) in degrees
  time frame: preoperative
  description: Measured on anteroposterior and lateral radiographs and defined as the angle from upper to lower most tilted end vertebrae.
  measure: Sagittal deformity angular ratio (SDAR)
  time frame: preoperative
  description: Divided GK by the number of levels spanning the curve.
  arm group label: Type A
  description: Type A was defined as a round/oval spinal cord shape with visible cerebrospinal fluid (CSF) between the cord and the apical vertebrae.
  arm group label: Type B
  description: Type B was defined as a round/oval spinal cord shape with no CSF between the apical vertebrae and spinal cord.
  arm group label: Type C
  description: Type C cord was defined as a spinal cord that is fattened/deformed by the vertebral body, with no visible CSF between the apex and the cord.
  intervention type: Radiation
  intervention name: Variation in anisotropy of the Spinal Cord using diffusion tensor imaging
  description: All examinations were performed on a 3.0-T MRI machine with a 12-channel spine special coil (Ingenia CX, Philips Healthcare, Best, the Netherlands). The multi-sequence MRI protocol included conventional T1-weighted (sag & tra), T2-weighted (sag & tra), and DTI sequence.
  arm group label: Type A
  arm group label: Type B
  arm group label: Type C
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 78 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Kyphosis
  sharing ipd: No