<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/NCT04426916</url>
  </required_header>
  <id_info>
    <org_study_id>H-2005-149-1125</org_study_id>
    <nct_id>NCT04426916</nct_id>
  </id_info>
  <brief_title>Spine Ultrasound Image Study of Spondylolisthesis Patient</brief_title>
  <official_title>Ultrasound Image Study to Evaluate the Optimal Angulation of Needle Insertion for Spinal Anesthesia in Patients With Spondylolisthesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is to evaluate the anatomical characteristics of spondylolisthesis patients using&#xD;
      spine ultrasound imaging. The optimal angle of spinal needle insertion for spinal anesthesia&#xD;
      in spondylolisthesis patients was compared to that of normal patients without abnormal spinal&#xD;
      anatomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">August 7, 2020</completion_date>
  <primary_completion_date type="Actual">August 6, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>The predicted optimal angle of spinal needle insertion for spinal anesthesia at the level of spondylolisthesis. (alpha 1)</measure>
    <time_frame>Preanesthesia</time_frame>
    <description>The needle insertion angle where the height of ligamentum flavum/dura mater complex(LFD) is measured the longest in ultrasound image.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The predicted optimal angle of spinal needle insertion for spinal anesthesia at the one upper level of spondylolisthesis. (alpha 2)</measure>
    <time_frame>Preanesthesia</time_frame>
    <description>The needle insertion angle where the height of LFD is measured the longest in ultrasound image.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The height of LFD measured by ultrasound image.</measure>
    <time_frame>Preanesthesia</time_frame>
    <description>The height of LFD at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 &amp; alpha 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The depth from skin (needle insertion point) to LFD.</measure>
    <time_frame>Preanesthesia</time_frame>
    <description>The depth from skin to LFD at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 &amp; alpha 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The depth from skin (needle insertion point) to posterior longitudinal ligament(PLL).</measure>
    <time_frame>Preanesthesia</time_frame>
    <description>The depth from skin to PLL at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 &amp; alpha 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' gender, age, height, weight, BMI, etc.</measure>
    <time_frame>Preanesthesia</time_frame>
    <description>gender, age, height, weight, BMI</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Spondylolisthesis</condition>
  <arm_group>
    <arm_group_label>normal lumbar spine</arm_group_label>
    <description>Patient without spondylolisthesis or significant spinal anatomic deformity. (ex&gt; severe spondylosis, spinal stenosis, scoliosis, etc..)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>spondylolisthesis</arm_group_label>
    <description>Spondylolisthesis patients, with whom the deformity is at just one level. The patients should not have any other significant spinal deformity. (ex&gt; severe spondylosis, spinal stenosis, scoliosis, etc..)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spondylolisthesis</intervention_name>
    <description>Spondylolisthesis at a single level</description>
    <arm_group_label>spondylolisthesis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients scheduled for elective orthopedic surgery in SNUH(Seoul national university&#xD;
        hospital) with ASA physical status classification system I, II, III.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients scheduled for elective orthopedic surgery.&#xD;
&#xD;
          -  with ASA physical status classification system I, II, III.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with communication difficulties.&#xD;
&#xD;
          -  Patient who can not take a lateral decubitus position for spinal anesthesia. (e.g)&#xD;
             fracture)&#xD;
&#xD;
          -  Patients with a medical history of spinal surgery.&#xD;
&#xD;
          -  Patients with significant spinal anatomical deformity any other than&#xD;
             spondylolisthesis. (for spondylolisthesis patients group)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Tae Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin-Tae Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>optimal angle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylolisthesis</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/NCT04426916
org study id: H-2005-149-1125
nct id: NCT04426916
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the anatomical characteristics of spondylolisthesis patients using
      spine ultrasound imaging. The optimal angle of spinal needle insertion for spinal anesthesia
      in spondylolisthesis patients was compared to that of normal patients without abnormal spinal
      anatomy.
observational model: Case-Control
time perspective: Prospective
measure: The predicted optimal angle of spinal needle insertion for spinal anesthesia at the level of spondylolisthesis. (alpha 1)
time frame: Preanesthesia
description: The needle insertion angle where the height of ligamentum flavum/dura mater complex(LFD) is measured the longest in ultrasound image.
measure: The predicted optimal angle of spinal needle insertion for spinal anesthesia at the one upper level of spondylolisthesis. (alpha 2)
time frame: Preanesthesia
description: The needle insertion angle where the height of LFD is measured the longest in ultrasound image.
measure: The height of LFD measured by ultrasound image.
time frame: Preanesthesia
description: The height of LFD at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 & alpha 2.
measure: The depth from skin (needle insertion point) to LFD.
time frame: Preanesthesia
description: The depth from skin to LFD at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 & alpha 2.
measure: The depth from skin (needle insertion point) to posterior longitudinal ligament(PLL).
time frame: Preanesthesia
description: The depth from skin to PLL at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 & alpha 2.
measure: Patients' gender, age, height, weight, BMI, etc.
time frame: Preanesthesia
description: gender, age, height, weight, BMI
arm group label: normal lumbar spine
description: Patient without spondylolisthesis or significant spinal anatomic deformity. (ex> severe spondylosis, spinal stenosis, scoliosis, etc..)
arm group label: spondylolisthesis
description: Spondylolisthesis patients, with whom the deformity is at just one level. The patients should not have any other significant spinal deformity. (ex> severe spondylosis, spinal stenosis, scoliosis, etc..)
intervention type: Other
intervention name: Spondylolisthesis
description: Spondylolisthesis at a single level
arm group label: spondylolisthesis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Jin-Tae Kim, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: Professor
mesh term: Spondylolisthesis