<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/NCT03269851</url>
  </required_header>
  <id_info>
    <org_study_id>Neurological deficit</org_study_id>
    <secondary_id>Thoracolumbar fractures</secondary_id>
    <nct_id>NCT03269851</nct_id>
  </id_info>
  <brief_title>Parameters of Neurological Deficit After Thoracolumbar Fractures</brief_title>
  <official_title>Radiological Parameters Predicting Neurological Injury After Thoracolumbar Spinal Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      To detect Radiological parameters affecting neurological injury after thoracolumbar spinal&#xD;
      fractures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thoracolumbar spine fractures are the most common spinal column fractures. High activity and&#xD;
      lack of stability make it more prone to fractures.&#xD;
&#xD;
      Many studies have attempted to determine whether the neurological deficit in such fractures&#xD;
      is related to spinal canal stenosis or other parameters observed on axial computed tomography&#xD;
      (CT). However, this relationship remains controversial.&#xD;
&#xD;
      Few reports shed light on the relation between different imaging parameters like sagittal&#xD;
      alignment, vertebral body compression, canal stenosis, and type of fracture according to AO&#xD;
      classification with the severity of nerve damage.&#xD;
&#xD;
      These four radiographic parameters will be tested as expected risk factors for the&#xD;
      neurological deficit in thoracolumbar fractures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">March 21, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To Measure spinal canal stenosis by cubic cm</measure>
    <time_frame>one year</time_frame>
    <description>CT-Radiological parameters measured in patients with or without thoracolumbar fractures .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure sagittal alignment of vertebral column by cobb angle</measure>
    <time_frame>one year</time_frame>
    <description>CT-Radiological parameters measured in patients with or without thoracolumbar fractures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure vertebral body compression by cm</measure>
    <time_frame>one year</time_frame>
    <description>CT-Radiological parameters measured in patients with or without thoracolumbar fractures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure type of fracture according to AO classification</measure>
    <time_frame>one year</time_frame>
    <description>CT-Radiological parameters measured in patients with or without thoracolumbar fractures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Neurological deficit among patients with thoracolumbar spine fractures.</measure>
    <time_frame>one year</time_frame>
    <description>Number of patients with neurological deficit to the total number of patients with thoracolumbar spine fractures.</description>
  </secondary_outcome>
  <enrollment type="Actual">160</enrollment>
  <condition>SPINAL Fracture</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>computed tomography</intervention_name>
    <description>ct will be done to detect radiological risk factors for neurological deficits after thoracolumbar fractures</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient with Acute (within one month) thoracolumbar spine fracture above 18 years old&#xD;
        with or without neurological deficit in orthopaedics and trauma department of Assiut&#xD;
        university hospital from 1st of November 2018 to 31 st of October 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Any patient with Acute (within one month) thoracolumbar spine fracture above 18 years&#xD;
             old with or without neurological deficit&#xD;
&#xD;
          2. In orthopaedics and trauma department of Assiut university hospital from 1st of&#xD;
             November 2018 to 31 st of October 2019.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years old.&#xD;
&#xD;
          -  Patients suffering from preoperative neurological diseases that hinder our examination&#xD;
             like peripheral neuropathy or previous strokes.&#xD;
&#xD;
          -  Obtuned patients who cannot be properly examined like those with low GCS score.&#xD;
&#xD;
          -  Patients with old thoracolumbar fractures more than one month duration.&#xD;
&#xD;
          -  Patients with pathological spine fractures like those with osteoporosis and cancer&#xD;
             metastasis.&#xD;
&#xD;
          -  Patients with fracture type A0 according to AO classification.&#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>Mohammed G. Hassan</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut University Hospital</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.1097/00007632-200102150-00013</url>
    <description>The significance of thoracolumbar spinal canal size in spinal cord injury patients.</description>
  </link>
  <link>
    <url>http://bjj.boneandjoint.org.uk/content/74-B/5/683.short</url>
    <description>CT scan prediction of neurological deficit in thoracolumbar burst fractures.</description>
  </link>
  <link>
    <url>https://doi.org/10.1097/00007632-198811000-00011</url>
    <description>Relationship between traumatic spinal canal stenosis and neurologic deficits in thoracolumbar burst fractures.</description>
  </link>
  <link>
    <url>https://doi.org/10.1097/00007632-199902010-00020</url>
    <description>Neurologic injury and recovery in patients with burst fracture of the thoracolumbar spine.</description>
  </link>
  <link>
    <url>https://doi.org/10.1097/01.brs.0000231730.34754.9e</url>
    <description>Correlation among canal compromise, neurologic deficit, and injury severity in thoracolumbar burst fractures.</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Zamboo Safwat</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>neurological deficit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Spinal Fractures</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/NCT03269851
org study id: Neurological deficit
secondary id: Thoracolumbar fractures
nct id: NCT03269851
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To detect Radiological parameters affecting neurological injury after thoracolumbar spinal
      fractures.
Thoracolumbar spine fractures are the most common spinal column fractures. High activity and
      lack of stability make it more prone to fractures.

      Many studies have attempted to determine whether the neurological deficit in such fractures
      is related to spinal canal stenosis or other parameters observed on axial computed tomography
      (CT). However, this relationship remains controversial.

      Few reports shed light on the relation between different imaging parameters like sagittal
      alignment, vertebral body compression, canal stenosis, and type of fracture according to AO
      classification with the severity of nerve damage.

      These four radiographic parameters will be tested as expected risk factors for the
      neurological deficit in thoracolumbar fractures.
observational model: Case-Only
time perspective: Cross-Sectional
measure: To Measure spinal canal stenosis by cubic cm
time frame: one year
description: CT-Radiological parameters measured in patients with or without thoracolumbar fractures .
measure: To measure sagittal alignment of vertebral column by cobb angle
time frame: one year
description: CT-Radiological parameters measured in patients with or without thoracolumbar fractures
measure: To measure vertebral body compression by cm
time frame: one year
description: CT-Radiological parameters measured in patients with or without thoracolumbar fractures
measure: To measure type of fracture according to AO classification
time frame: one year
description: CT-Radiological parameters measured in patients with or without thoracolumbar fractures
measure: Proportion of Neurological deficit among patients with thoracolumbar spine fractures.
time frame: one year
description: Number of patients with neurological deficit to the total number of patients with thoracolumbar spine fractures.
intervention type: Radiation
intervention name: computed tomography
description: ct will be done to detect radiological risk factors for neurological deficits after thoracolumbar fractures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohammed G. Hassan
role: Study Chair
affiliation: Assiut University
facility: 
country: Egypt
url: https://doi.org/10.1097/00007632-200102150-00013
description: The significance of thoracolumbar spinal canal size in spinal cord injury patients.
url: http://bjj.boneandjoint.org.uk/content/74-B/5/683.short
description: CT scan prediction of neurological deficit in thoracolumbar burst fractures.
url: https://doi.org/10.1097/00007632-198811000-00011
description: Relationship between traumatic spinal canal stenosis and neurologic deficits in thoracolumbar burst fractures.
url: https://doi.org/10.1097/00007632-199902010-00020
description: Neurologic injury and recovery in patients with burst fracture of the thoracolumbar spine.
url: https://doi.org/10.1097/01.brs.0000231730.34754.9e
description: Correlation among canal compromise, neurologic deficit, and injury severity in thoracolumbar burst fractures.
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Zamboo Safwat
investigator title: Principal investigator
mesh term: Fractures, Bone
mesh term: Spinal Fractures