<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/NCT01721889</url>
  </required_header>
  <id_info>
    <org_study_id>RSA100</org_study_id>
    <nct_id>NCT01721889</nct_id>
  </id_info>
  <brief_title>Radiostereometric Analysis of Spine Arthrodesis</brief_title>
  <official_title>Radiostereometric Analysis of Spine Arthrodesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OAD Orthopaedics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Halifax Biomedical Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central DuPage Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OAD Orthopaedics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this pilot study is to determine the precision of post-operative&#xD;
      radiostereometric measurements for the assessment of lumbar spinal fusion. This study will&#xD;
      also determine the potential for RSA as a more precise and accurate means for assessment of&#xD;
      lumbar spinal fusion and diagnosis of pseudarthrosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intervertebral motion post-op lumbar fusion</measure>
    <time_frame>2 years</time_frame>
    <description>The purpose of this radiostereometric analysis (RSA) evaluation is to measure relative intervertebral motion in lumbar spinal fusions. Two RSA loading provocation protocols will be employed in this study; sitting and supine extension. Both loading protocols will be compard to a standard supine position which is used as an unloaded baseline protocol. Induced intervetebral motion sets will be calculated between the two loaded states, sitting and supine extension, and the unloaded state. The RSA micromotion results will be calculated and reported as translations and rotations about the three anatomic axes, maximum total point motion (MTPM) will be calculated as well.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Lumbar Degenerative Disc Disease</condition>
  <arm_group>
    <arm_group_label>Radiostereometric analysis - Intact fusion</arm_group_label>
    <description>Clinically fused per classical radiographic assessment (≤ 2 degrees angular motion and evidence of bone bridging)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiostereometric analysis - Symptomatic pseudoarthrosis</arm_group_label>
    <description>Definitive clinical evidence of pseudarthrosis (not fused, ˃ 2 degrees angular motion or absence of bone bridge) and scheduled for surgical exploration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiostereometric analysis - Asymptomatic pseudoarthrosis</arm_group_label>
    <description>Definitive clinical evidence of pseudarthrosis without scheduled surgical exploration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiostereometric Analysis</intervention_name>
    <description>The radiostereometric (RSA) patient exam (flexion and extension RSA images) presents additional radiation exposure to the patient above standard of care (additional radiographs). Assuming 120kV, using three protocols (two loaded and one unloaded) per RSA exam results in a typical effective dose of approximately 2.04mSv per exam(single lumbar spine RSA at 120kV yields 0.68mSv,). HBI recommends using 140kV for lumbar spine RSA and has conducted simulations to estimate the effective dose using higher kV settings. 140kV reduces the effective dose from 0.68mSv per spine RSA to 0.2mSV, resulting in a total effective dose per RSA exam of 0.6mSv. In comparison, the estimated effective dose for a single standard lumbar spine x-ray is 1.2mSv. This additional radiation exposure is considered to be minimal risk in consideration of the number of planar x-rays the patient will undergo as part of standard care, as well as average background radiation received by humans per year (3.1mSv).</description>
    <arm_group_label>Radiostereometric analysis - Asymptomatic pseudoarthrosis</arm_group_label>
    <arm_group_label>Radiostereometric analysis - Intact fusion</arm_group_label>
    <arm_group_label>Radiostereometric analysis - Symptomatic pseudoarthrosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients between the ages of 18 and 75 that are diagnosed with lumbar DDD (L1-L5, and also&#xD;
        L5-S1) and scheduled for one or multi level spinal fusion surgery will be recruited for the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic degenerative disc disease of the lumbar spine indication surgical&#xD;
             intervention&#xD;
&#xD;
          -  Scheduled to undergo lumbar fusion surgery&#xD;
&#xD;
          -  Patients between the ages of 18 and 75&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Andreshak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OAD Orthopaedics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marjorie Delaney, APN</last_name>
    <phone>630-225-2554</phone>
    <email>marjorie.delaney@oadortho.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>John Andreshak, MD</last_name>
    <phone>630-225-2663</phone>
    <email>john.andreshak@oadortho.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>OAD Orthopaedics</name>
      <address>
        <city>Warrenville</city>
        <state>Illinois</state>
        <zip>60555</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marjorie Delaney, APN</last_name>
      <phone>630-225-2554</phone>
      <email>marjorie.delaney@oadortho.com</email>
    </contact>
    <investigator>
      <last_name>John Andreshak, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stephen Heim, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jerome Kolavo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>June 10, 2013</last_update_submitted>
  <last_update_submitted_qc>June 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</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/NCT01721889
org study id: RSA100
nct id: NCT01721889
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The primary objective of this pilot study is to determine the precision of post-operative
      radiostereometric measurements for the assessment of lumbar spinal fusion. This study will
      also determine the potential for RSA as a more precise and accurate means for assessment of
      lumbar spinal fusion and diagnosis of pseudarthrosis.
observational model: Case-Only
time perspective: Prospective
measure: Intervertebral motion post-op lumbar fusion
time frame: 2 years
description: The purpose of this radiostereometric analysis (RSA) evaluation is to measure relative intervertebral motion in lumbar spinal fusions. Two RSA loading provocation protocols will be employed in this study; sitting and supine extension. Both loading protocols will be compard to a standard supine position which is used as an unloaded baseline protocol. Induced intervetebral motion sets will be calculated between the two loaded states, sitting and supine extension, and the unloaded state. The RSA micromotion results will be calculated and reported as translations and rotations about the three anatomic axes, maximum total point motion (MTPM) will be calculated as well.
arm group label: Radiostereometric analysis - Intact fusion
description: Clinically fused per classical radiographic assessment (≤ 2 degrees angular motion and evidence of bone bridging)
arm group label: Radiostereometric analysis - Symptomatic pseudoarthrosis
description: Definitive clinical evidence of pseudarthrosis (not fused, ˃ 2 degrees angular motion or absence of bone bridge) and scheduled for surgical exploration
arm group label: Radiostereometric analysis - Asymptomatic pseudoarthrosis
description: Definitive clinical evidence of pseudarthrosis without scheduled surgical exploration.
intervention type: Radiation
intervention name: Radiostereometric Analysis
description: The radiostereometric (RSA) patient exam (flexion and extension RSA images) presents additional radiation exposure to the patient above standard of care (additional radiographs). Assuming 120kV, using three protocols (two loaded and one unloaded) per RSA exam results in a typical effective dose of approximately 2.04mSv per exam(single lumbar spine RSA at 120kV yields 0.68mSv,). HBI recommends using 140kV for lumbar spine RSA and has conducted simulations to estimate the effective dose using higher kV settings. 140kV reduces the effective dose from 0.68mSv per spine RSA to 0.2mSV, resulting in a total effective dose per RSA exam of 0.6mSv. In comparison, the estimated effective dose for a single standard lumbar spine x-ray is 1.2mSv. This additional radiation exposure is considered to be minimal risk in consideration of the number of planar x-rays the patient will undergo as part of standard care, as well as average background radiation received by humans per year (3.1mSv).
arm group label: Radiostereometric analysis - Asymptomatic pseudoarthrosis
arm group label: Radiostereometric analysis - Intact fusion
arm group label: Radiostereometric analysis - Symptomatic pseudoarthrosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: John Andreshak, MD
role: Principal Investigator
affiliation: OAD Orthopaedics
last name: Marjorie Delaney, APN
phone: 630-225-2554
email: marjorie.delaney@oadortho.com
last name: John Andreshak, MD
phone: 630-225-2663
email: john.andreshak@oadortho.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Intervertebral Disc Degeneration