<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/NCT03272243</url>
  </required_header>
  <id_info>
    <org_study_id>G10800</org_study_id>
    <nct_id>NCT03272243</nct_id>
  </id_info>
  <brief_title>Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures</brief_title>
  <official_title>Short Segment Posterior Fixation With Index Level Screws Versus Long Segment Posterior Fixation for Thoracolumbar Spine Fracture: Angle of Correction and Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
      A prospective study included 91 patients, who had single level thoracolumbar fracture with&#xD;
      Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment&#xD;
      fixation with screws into the index level, and 47 patients underwent long segment fixation&#xD;
      with skipped index level. The angle of correction, pain, and neurological state were&#xD;
      regularly assessed&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2012</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">February 28, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain</measure>
    <time_frame>3rd, 6th, 9th, 12th months</time_frame>
    <description>Visual analogue scale assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in disability</measure>
    <time_frame>3rd, 6th, 9th, 12th months</time_frame>
    <description>assessment of Oswestry Disability Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in angle of correction</measure>
    <time_frame>3rd, 6th, 9th, 12th months</time_frame>
    <description>Measurement of Cobb's angle</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>SPINAL Fracture</condition>
  <arm_group>
    <arm_group_label>Short Segment posterior spine fixation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Short segment transpedicular screw fixation with inclusion of the index level</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Long Segment posterior spine fixation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Long segment transpedicular screw fixation with escape of the index level</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>short segment posterior spine fixation</intervention_name>
    <arm_group_label>Short Segment posterior spine fixation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>long segment posterior spine fixation</intervention_name>
    <arm_group_label>Long Segment posterior spine fixation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  wedge fracture or burst fracture with Thoraco-Lumbar Injury Classification and&#xD;
             Severity (TLICS) score ≥ 4&#xD;
&#xD;
          -  Single level fracture&#xD;
&#xD;
          -  Less than 50% of spinal canal compromised&#xD;
&#xD;
          -  Mild kyphosis or scoliosis&#xD;
&#xD;
          -  Cobb's angle ≤ 25˚&#xD;
&#xD;
          -  with or without neurological deficit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with multiple level fractures&#xD;
&#xD;
          -  patients with more than 50% spinal canal compromise&#xD;
&#xD;
          -  patients who needed anterior approach to decompress the canal&#xD;
&#xD;
          -  patients who have fracture dislocation and / or marked kyphosis and scoliosis with&#xD;
             Cobb's angle &gt;25⁰&#xD;
&#xD;
          -  patients who needed 360⁰ fixation with long segment fixation to maintain the angle of&#xD;
             correction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Walid A Abdel Ghany, M.D., Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Neurosurgery</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Mohamed Nada</investigator_full_name>
    <investigator_title>Fellow of functional neurosurgery division</investigator_title>
  </responsible_party>
  <keyword>thoracolumbar fracture</keyword>
  <keyword>short segment fixation</keyword>
  <keyword>long segment fixation</keyword>
  <keyword>index level</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <pending_results>
    <submitted>March 30, 2018</submitted>
    <returned>October 30, 2018</returned>
  </pending_results>
  <!-- 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/NCT03272243
org study id: G10800
nct id: NCT03272243
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective study included 91 patients, who had single level thoracolumbar fracture with
      Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment
      fixation with screws into the index level, and 47 patients underwent long segment fixation
      with skipped index level. The angle of correction, pain, and neurological state were
      regularly assessed
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in pain
time frame: 3rd, 6th, 9th, 12th months
description: Visual analogue scale assessment
measure: Change in disability
time frame: 3rd, 6th, 9th, 12th months
description: assessment of Oswestry Disability Scale
measure: Change in angle of correction
time frame: 3rd, 6th, 9th, 12th months
description: Measurement of Cobb's angle
arm group label: Short Segment posterior spine fixation
arm group type: Active Comparator
description: Short segment transpedicular screw fixation with inclusion of the index level
arm group label: Long Segment posterior spine fixation
arm group type: Active Comparator
description: Long segment transpedicular screw fixation with escape of the index level
intervention type: Procedure
intervention name: short segment posterior spine fixation
arm group label: Short Segment posterior spine fixation
intervention type: Procedure
intervention name: long segment posterior spine fixation
arm group label: Long Segment posterior spine fixation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Walid A Abdel Ghany, M.D., Ph.D
role: Study Director
affiliation: Associate Professor of Neurosurgery
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Mohamed Nada
investigator title: Fellow of functional neurosurgery division
mesh term: Fractures, Bone
mesh term: Spinal Fractures
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
submitted: March 30, 2018
returned: October 30, 2018