<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/NCT02187666</url>
  </required_header>
  <id_info>
    <org_study_id>NOC 1001</org_study_id>
    <nct_id>NCT02187666</nct_id>
  </id_info>
  <brief_title>NOC2 Spine Registry</brief_title>
  <official_title>National Neurosurgical and Orthopedic Optimum Care Continuum Spine Registry Exposure for Various Implants/Products</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)</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 the Spine Registry is to enhance the understanding of spinal disease&#xD;
      and treatment of spinal disease with the goal of guiding treatment options.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enhance the understanding of the variability, progression and treatment of&#xD;
      spinal disease with the ultimate goal of better guiding and assessing therapeutic&#xD;
      intervention. Researchers will collect complications and safety following cervical and lumbar&#xD;
      surgeries to determine best options for patients. Prospective reports will be collected on&#xD;
      patients undergoing lumbar or cervical spinal surgery. Patients will be enrolled in registry&#xD;
      after signing informed consent. Data will be collected at various time points. The registry&#xD;
      will serve as a database of cervical and lumbar surgeries in which retrospective analysis and&#xD;
      exploratory analysis of specific research questions can be answered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 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>2 Years</target_duration>
  <primary_outcome>
    <measure>Change in Visual Analogue Scale (VAS) from baseline at 4 weeks</measure>
    <time_frame>baseline and 4 weeks after surgery</time_frame>
    <description>Pain intensity scale taken at baseline and 4 weeks after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Visual Analogue Scale (VAS) from baseline at 3 months</measure>
    <time_frame>baseline and 3 months after surgery</time_frame>
    <description>Pain intensity scale taken at baseline and 3 months after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Visual Analogue Scale (VAS) from baseline at 6 months</measure>
    <time_frame>baseline and 6 months after surgery</time_frame>
    <description>Pain intensity scale taken at baseline and 6 months after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Visual Analogue Scale (VAS) from baseline at 12 months</measure>
    <time_frame>baseline and 12 months after surgery</time_frame>
    <description>Pain intensity scale taken at baseline and 12 months after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Visual Analogue Scale (VAS) from baseline at 24 months</measure>
    <time_frame>baseline and 24 months after surgery</time_frame>
    <description>Pain intensity scale taken at baseline and 24 months after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Oswestry Disability index at 4 weeks</measure>
    <time_frame>baseline and 4 weeks after surgery</time_frame>
    <description>Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 4 weeks after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fusion at 6 months</measure>
    <time_frame>6 months post-op</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>one to three days following surgery</time_frame>
    <description>Date of discharge will be recorded, an average of one to three days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revision surgery within 30 days</measure>
    <time_frame>30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>Time off of work and whether patient returned restricted or unrestricted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to normal/usual activity</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>Time between surgery and resuming normal activity for patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>24 hours after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Oswestry Disability index at 3 months</measure>
    <time_frame>baseline and 3 months after surgery</time_frame>
    <description>Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 3 months after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Oswestry Disability index at 6 months</measure>
    <time_frame>baseline and 6 months after surgery</time_frame>
    <description>Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 6 months after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Oswestry Disability index at 12 months</measure>
    <time_frame>baseline and 12 months after surgery</time_frame>
    <description>Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 12 months after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Oswestry Disability index at 24 months</measure>
    <time_frame>baseline and 24 months after surgery</time_frame>
    <description>Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 24 months after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Time off of work and whether patient returned restricted or unrestricted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Time off of work and whether patient returned restricted or unrestricted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Time off of work and whether patient returned restricted or unrestricted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>24 months after surgery</time_frame>
    <description>Time off of work and whether patient returned restricted or unrestricted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to normal/usual activity</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Time between surgery and resuming normal activity for patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to normal/usual activity</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Time between surgery and resuming normal activity for patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to normal/usual activity</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Time between surgery and resuming normal activity for patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to normal/usual activity</measure>
    <time_frame>24 months after surgery</time_frame>
    <description>Time between surgery and resuming normal activity for patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>4 weeks after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>3 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>6 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>12 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>24 months after surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Spinal Disease</condition>
  <arm_group>
    <arm_group_label>Lumbar</arm_group_label>
    <description>Patients undergoing lumbar spinal surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical</arm_group_label>
    <description>Patients undergoing cervical spine surgery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 10,000 patients undergoing lumbar or cervical surgery will be screened to&#xD;
        decide whether they meet the inclusion and exclusion criteria of the study/patient&#xD;
        registry. Patients who meet the study criteria will be informed by the investigator and&#xD;
        should read the 'patient information' document. Patients must give their written informed&#xD;
        consent to be enrolled into this study.&#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;
          -  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>N/A</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>37211</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 9, 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>Cervical</keyword>
  <keyword>Lumbar</keyword>
  <keyword>Spine</keyword>
  <keyword>Spinal Disease</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/NCT02187666
org study id: NOC 1001
nct id: NCT02187666
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The primary objective of the Spine Registry is to enhance the understanding of spinal disease
      and treatment of spinal disease with the goal of guiding treatment options.
This study will enhance the understanding of the variability, progression and treatment of
      spinal disease with the ultimate goal of better guiding and assessing therapeutic
      intervention. Researchers will collect complications and safety following cervical and lumbar
      surgeries to determine best options for patients. Prospective reports will be collected on
      patients undergoing lumbar or cervical spinal surgery. Patients will be enrolled in registry
      after signing informed consent. Data will be collected at various time points. The registry
      will serve as a database of cervical and lumbar surgeries in which retrospective analysis and
      exploratory analysis of specific research questions can be answered.
observational model: Cohort
time perspective: Prospective
measure: Change in Visual Analogue Scale (VAS) from baseline at 4 weeks
time frame: baseline and 4 weeks after surgery
description: Pain intensity scale taken at baseline and 4 weeks after surgery
measure: Change in Visual Analogue Scale (VAS) from baseline at 3 months
time frame: baseline and 3 months after surgery
description: Pain intensity scale taken at baseline and 3 months after surgery
measure: Change in Visual Analogue Scale (VAS) from baseline at 6 months
time frame: baseline and 6 months after surgery
description: Pain intensity scale taken at baseline and 6 months after surgery
measure: Change in Visual Analogue Scale (VAS) from baseline at 12 months
time frame: baseline and 12 months after surgery
description: Pain intensity scale taken at baseline and 12 months after surgery
measure: Change in Visual Analogue Scale (VAS) from baseline at 24 months
time frame: baseline and 24 months after surgery
description: Pain intensity scale taken at baseline and 24 months after surgery
measure: Change from baseline in Oswestry Disability index at 4 weeks
time frame: baseline and 4 weeks after surgery
description: Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 4 weeks after surgery.
measure: Fusion at 6 months
time frame: 6 months post-op
measure: Length of hospital stay
time frame: one to three days following surgery
description: Date of discharge will be recorded, an average of one to three days
measure: Revision surgery within 30 days
time frame: 30 days after surgery
measure: Return to work
time frame: 4 weeks after surgery
description: Time off of work and whether patient returned restricted or unrestricted
measure: Return to normal/usual activity
time frame: 4 weeks after surgery
description: Time between surgery and resuming normal activity for patient
measure: Complications
time frame: 24 hours after surgery
measure: Change from baseline in Oswestry Disability index at 3 months
time frame: baseline and 3 months after surgery
description: Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 3 months after surgery.
measure: Change from baseline in Oswestry Disability index at 6 months
time frame: baseline and 6 months after surgery
description: Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 6 months after surgery.
measure: Change from baseline in Oswestry Disability index at 12 months
time frame: baseline and 12 months after surgery
description: Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 12 months after surgery.
measure: Change from baseline in Oswestry Disability index at 24 months
time frame: baseline and 24 months after surgery
description: Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 24 months after surgery.
measure: Return to work
time frame: 3 months after surgery
description: Time off of work and whether patient returned restricted or unrestricted
measure: Return to work
time frame: 6 months after surgery
description: Time off of work and whether patient returned restricted or unrestricted
measure: Return to work
time frame: 12 months after surgery
description: Time off of work and whether patient returned restricted or unrestricted
measure: Return to work
time frame: 24 months after surgery
description: Time off of work and whether patient returned restricted or unrestricted
measure: Return to normal/usual activity
time frame: 3 months after surgery
description: Time between surgery and resuming normal activity for patient
measure: Return to normal/usual activity
time frame: 6 months after surgery
description: Time between surgery and resuming normal activity for patient
measure: Return to normal/usual activity
time frame: 12 months after surgery
description: Time between surgery and resuming normal activity for patient
measure: Return to normal/usual activity
time frame: 24 months after surgery
description: Time between surgery and resuming normal activity for patient
measure: Complications
time frame: 4 weeks after surgery
measure: Complications
time frame: 3 months after surgery
measure: Complications
time frame: 6 months after surgery
measure: Complications
time frame: 12 months after surgery
measure: Complications
time frame: 24 months after surgery
arm group label: Lumbar
description: Patients undergoing lumbar spinal surgery
arm group label: Cervical
description: Patients undergoing cervical spine surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
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