<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/NCT03768843</url>
  </required_header>
  <id_info>
    <org_study_id>Sohag3</org_study_id>
    <nct_id>NCT03768843</nct_id>
  </id_info>
  <brief_title>Surgical Outcome of Type II Odontoid Fracture, Harms Technique</brief_title>
  <official_title>Surgical Outcome of Type II Odontoid Fracture, Harms Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sohag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sohag 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>
      Cervical trauma is a common cause of disability following spinal cord injury, especially in&#xD;
      athletic populations. The biomechanics in the atlantoaxial joint carry more than 50% of the&#xD;
      rotational movement which can be affected in transverse ligament tear associated with&#xD;
      odontoid fracture type II. Odontoid fracture type II considered an unstable fracture with a&#xD;
      high rate of non-union in conservative treatment. Limitation of the odontoid screws in some&#xD;
      cases gives the chance of posterior cervical fixation to have the superior role. Use of&#xD;
      polyaxial screws in Harms technique gives the best results in maintaining the majority of the&#xD;
      biomechanics.&#xD;
&#xD;
      Purpose: our aim in this study to evaluate Harms technique in those patients regarding pain&#xD;
      improvement and restoration of the motor power and to report the complications.&#xD;
&#xD;
      Study design: A retrospective case series study. We Used the Frankel grading system to&#xD;
      evaluate the postoperative neurological state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval of Research Ethics Committee, twelve patients with post-traumatic odontoid&#xD;
      fracture type II were scheduled in our Neurosurgery department at Sohag University Hospital&#xD;
      for atlantoaxial fusion using polyaxial C1 lateral mass and C2 pedicle screws between January&#xD;
      2015 and January 2018.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>evaluation neurological deficit using Frankel grading system within 3 years</measure>
    <time_frame>3 years</time_frame>
    <description>grades from A to E and A is the best neurological function while E is the worst neurological function</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Tramatic Odontoid Fracture</condition>
  <arm_group>
    <arm_group_label>traumatic odontoid fracture</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>C1 C2 fusion screws</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Harms technique</intervention_name>
    <description>Atlantoaxial fusion</description>
    <arm_group_label>traumatic odontoid fracture</arm_group_label>
    <other_name>C1 C2 fusion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. C1-C2 displacement that needs intra-operative reduction&#xD;
&#xD;
          2. Short neck not suitable for anterior odontoid screw&#xD;
&#xD;
          3. Osteoporotic patients&#xD;
&#xD;
          4. Odontoid fracture associated with transverse ligament tear suspected.&#xD;
&#xD;
          5. Oblique line of fracture&#xD;
&#xD;
          6. Failure of union after conservative treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated spinal fractures&#xD;
&#xD;
          -  Other comorbidities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hisham A Elsharkawy, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Sohag faculty of medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmed Salaheldin Mohammed Saro</name>
      <address>
        <city>Sohag</city>
        <zip>82511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sohag University</investigator_affiliation>
    <investigator_full_name>ahmed salaheldin mohammed saro</investigator_full_name>
    <investigator_title>Assistant professor of neurosurgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</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/NCT03768843
org study id: Sohag3
nct id: NCT03768843
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cervical trauma is a common cause of disability following spinal cord injury, especially in
      athletic populations. The biomechanics in the atlantoaxial joint carry more than 50% of the
      rotational movement which can be affected in transverse ligament tear associated with
      odontoid fracture type II. Odontoid fracture type II considered an unstable fracture with a
      high rate of non-union in conservative treatment. Limitation of the odontoid screws in some
      cases gives the chance of posterior cervical fixation to have the superior role. Use of
      polyaxial screws in Harms technique gives the best results in maintaining the majority of the
      biomechanics.

      Purpose: our aim in this study to evaluate Harms technique in those patients regarding pain
      improvement and restoration of the motor power and to report the complications.

      Study design: A retrospective case series study. We Used the Frankel grading system to
      evaluate the postoperative neurological state.
After approval of Research Ethics Committee, twelve patients with post-traumatic odontoid
      fracture type II were scheduled in our Neurosurgery department at Sohag University Hospital
      for atlantoaxial fusion using polyaxial C1 lateral mass and C2 pedicle screws between January
      2015 and January 2018.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: evaluation neurological deficit using Frankel grading system within 3 years
time frame: 3 years
description: grades from A to E and A is the best neurological function while E is the worst neurological function
arm group label: traumatic odontoid fracture
arm group type: Other
description: C1 C2 fusion screws
intervention type: Procedure
intervention name: Harms technique
description: Atlantoaxial fusion
arm group label: traumatic odontoid fracture
other name: C1 C2 fusion
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hisham A Elsharkawy, Professor
role: Study Director
affiliation: Sohag faculty of medicine
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Sohag University
investigator full name: ahmed salaheldin mohammed saro
investigator title: Assistant professor of neurosurgery
mesh term: Fractures, Bone