<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/NCT02187653</url>
  </required_header>
  <id_info>
    <org_study_id>DOC 1002</org_study_id>
    <nct_id>NCT02187653</nct_id>
  </id_info>
  <brief_title>Intraoperative Monitoring (IOM) Patient Registry</brief_title>
  <acronym>IOM</acronym>
  <official_title>Spine Registry Exposure for: Lumbar and Cervical Surgery Utilizing IOM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DC2 Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Research Independent Operations Management</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>DC2 Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the rate of new or worsening neurologic&#xD;
      deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using&#xD;
      neurological testing (motor and sensory) in the optimal management of the surgical patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective reports will be collected on approximately 10,000 patients undergoing lumbar or&#xD;
      cervical spinal surgery using intraoperative monitoring. Patients will be enrolled in&#xD;
      registry after signing informed consent. Data will be collected prior to surgery, during&#xD;
      surgery, immediately following surgery and 4 to 6 weeks post surgery. The registry will serve&#xD;
      as a database for surgeries using IOM.&#xD;
&#xD;
      Specific outcome measures will be: neurological assessment, length of hospital stay, pain&#xD;
      intensity, and complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>6 Weeks</target_duration>
  <primary_outcome>
    <measure>Change from baseline in Neurological Assessment at 24 hours</measure>
    <time_frame>baseline and 24 hours from time of surgery</time_frame>
    <description>Motor, Reflex, and Sensory testing will be assessed for change from baseline and 24 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Pain Intensity from Baseline at 24 hours</measure>
    <time_frame>baseline and 24 hours from time of surgery</time_frame>
    <description>Pain intensity will be measured by Visual Analogue Scale (VAS) for change from baseline and 24 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>At time of surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Neurological Assessment at 6 weeks</measure>
    <time_frame>baseline and 6 weeks</time_frame>
    <description>Motor, Reflex, and Sensory testing will be assessed for change from baseline, within 6 weeks but not less than 4 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Pain Intensity from Baseline at 6 weeks</measure>
    <time_frame>baseline and 6 weeks</time_frame>
    <description>Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>24 hours after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>6 weeks after surgery</time_frame>
    <description>within 6 weeks after surgery but not less than 4 weeks</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Intraoperative Monitoring</condition>
  <condition>Spinal Diseases</condition>
  <arm_group>
    <arm_group_label>Lumbar</arm_group_label>
    <description>Patients undergoing lumbar surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical</arm_group_label>
    <description>Patients undergoing cervical surgery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing cervical or lumbar surgery in which intraoperative monitoring has been&#xD;
        utilized.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing lumbar or cervical surgery&#xD;
&#xD;
          -  Utilization of IOM&#xD;
&#xD;
          -  Understand and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no specific exclusion criteria&#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_contact>
    <last_name>Christina R Cook, PhD</last_name>
    <phone>615-712-9574</phone>
    <email>ccook@dc2healthcare.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Risa Tyo, PharmD</last_name>
    <phone>615-712-9574</phone>
    <email>rtyo@dc2healthcare.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>DC2 Healthcare</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina R Cook, PhD</last_name>
      <phone>615-712-9574</phone>
      <email>ccook@dc2healthcare.com</email>
    </contact>
    <contact_backup>
      <last_name>Risa Tyo, PharmD</last_name>
      <phone>615-712-9574</phone>
      <email>rtyo@dc2healthcare.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.dc2healthcare.com</url>
    <description>DC2 Healthcare</description>
  </link>
  <link>
    <url>http://www.nriom.com/</url>
    <description>NRIOM</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IOM</keyword>
  <keyword>IONM</keyword>
  <keyword>Intraoperative Monitoring</keyword>
  <keyword>Intraoperative Neuromonitoring</keyword>
  <keyword>Spine</keyword>
  <keyword>Lumbar</keyword>
  <keyword>Cervical</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Diseases</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/NCT02187653
org study id: DOC 1002
nct id: NCT02187653
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The primary objective of this study is to evaluate the rate of new or worsening neurologic
      deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using
      neurological testing (motor and sensory) in the optimal management of the surgical patient.
Prospective reports will be collected on approximately 10,000 patients undergoing lumbar or
      cervical spinal surgery using intraoperative monitoring. Patients will be enrolled in
      registry after signing informed consent. Data will be collected prior to surgery, during
      surgery, immediately following surgery and 4 to 6 weeks post surgery. The registry will serve
      as a database for surgeries using IOM.

      Specific outcome measures will be: neurological assessment, length of hospital stay, pain
      intensity, and complications.
observational model: Cohort
time perspective: Prospective
measure: Change from baseline in Neurological Assessment at 24 hours
time frame: baseline and 24 hours from time of surgery
description: Motor, Reflex, and Sensory testing will be assessed for change from baseline and 24 hours after surgery
measure: Change in Pain Intensity from Baseline at 24 hours
time frame: baseline and 24 hours from time of surgery
description: Pain intensity will be measured by Visual Analogue Scale (VAS) for change from baseline and 24 hours after surgery
measure: Complications
time frame: At time of surgery
measure: Change from baseline in Neurological Assessment at 6 weeks
time frame: baseline and 6 weeks
description: Motor, Reflex, and Sensory testing will be assessed for change from baseline, within 6 weeks but not less than 4 weeks
measure: Change in Pain Intensity from Baseline at 6 weeks
time frame: baseline and 6 weeks
description: Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks
measure: Complications
time frame: 24 hours after surgery
measure: Complications
time frame: 6 weeks after surgery
description: within 6 weeks after surgery but not less than 4 weeks
arm group label: Lumbar
description: Patients undergoing lumbar surgery
arm group label: Cervical
description: Patients undergoing cervical surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christina R Cook, PhD
phone: 615-712-9574
email: ccook@dc2healthcare.com
last name: Risa Tyo, PharmD
phone: 615-712-9574
email: rtyo@dc2healthcare.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
url: http://www.dc2healthcare.com
description: DC2 Healthcare
url: http://www.nriom.com/
description: NRIOM
responsible party type: Sponsor
mesh term: Spinal Diseases