<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/NCT02210052</url>
  </required_header>
  <id_info>
    <org_study_id>14-003619</org_study_id>
    <nct_id>NCT02210052</nct_id>
  </id_info>
  <brief_title>Safety of Spine Radiofrequency Procedures</brief_title>
  <official_title>Safety of Lumbar Spine Radiofrequency Procedures in the Presence of Posterior Pedicle Screws: A Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the study was to determine if patients undergoing radiofrequency neurotomy (RFN)&#xD;
      of lumbar facet joints that are adjacent to previously placed pedicle screws from a fusion,&#xD;
      would lead to an increase in the temperature of the pedicle screws.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a prospective clinical trial, examining outcomes related to temperature&#xD;
      increases in pedicle screws. It was not possible to blind the investigators or the patient.&#xD;
      Outcomes related temperature differences were collected at each pedicle screw adjacent to a&#xD;
      zygapophyseal joint being treated.&#xD;
&#xD;
      A conventional 18-gauge, 1-cm curved active tip radiofrequency cannula was placed under&#xD;
      fluoroscopic guidance to the area to be treated (the junction of the transverse process and&#xD;
      the superior articulating process of the facet joint). This position placed the tip of the&#xD;
      radiofrequency cannula immediately adjacent to, but not in direct contact with, the pedicle&#xD;
      screws. The radiofrequency cannula was connected to a radiofrequency generator, and the&#xD;
      conventional settings for clinical medial branch neurotomy was used, heating the tissue to&#xD;
      80°C for 90 seconds. The procedure described up to this point is the normal procedure and&#xD;
      protocol for RFN performed at the Mayo Clinic.&#xD;
&#xD;
      The experimental portion of the procedure is as follows: A separate 22 gauge radiofrequency&#xD;
      cannula was intentionally placed in direct contact with the dorsal surface of the pedicle&#xD;
      screws and was connected to a radiofrequency generator solely for the purpose of measuring&#xD;
      temperature, as the RF cannula are dual purpose probes capable of both conducting energy for&#xD;
      the radiofrequency lesion and monitoring tissue temperature. In other words, this small gauge&#xD;
      needle was placed for the sole purpose of acting as a thermistor probe/temperature monitor.&#xD;
      This process was repeated for each level necessary for treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Procedures in Which Temperature of Screws Increased</measure>
    <time_frame>2 hours</time_frame>
    <description>The study will measure for increased temperature in pedicle screws adjacent to lumbar facet joints during radiofrequency neurotomy (RFN). Temperatures will be recorded by placing a thermistor probe on the surface of the adjacent hardware.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Radiofrequency Ablation in Patients With Spinal Hardware</condition>
  <arm_group>
    <arm_group_label>Radiofrequency neurotomy subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Radiofrequency cannula</intervention_name>
    <description>Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.</description>
    <arm_group_label>Radiofrequency neurotomy subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Scheduled for Radiofrequency procedure AND has spinal hardware placed from a previous&#xD;
        spinal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection over skin where needle will be placed&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tim J Lamer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gazelka HM, Welch TL, Nassr A, Lamer TJ. Safety of lumbar spine radiofrequency procedures in the presence of posterior pedicle screws: technical report of a cadaver study. Pain Med. 2015 May;16(5):877-80. doi: 10.1111/pme.12678. Epub 2015 Jan 8.</citation>
    <PMID>25580992</PMID>
  </reference>
  <results_reference>
    <citation>Lamer TJ, Smith J, Hoelzer BC, Mauck WD, Qu W, Gazelka HM. Safety of Lumbar Spine Radiofrequency Procedures in Patients Who Have Posterior Spinal Hardware. Pain Med. 2016 Sep;17(9):1634-7. doi: 10.1093/pm/pnv078. Epub 2016 Jan 13.</citation>
    <PMID>26764338</PMID>
  </results_reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <results_first_submitted>March 28, 2017</results_first_submitted>
  <results_first_submitted_qc>May 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 28, 2017</results_first_posted>
  <last_update_submitted>June 27, 2017</last_update_submitted>
  <last_update_submitted_qc>June 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Tim J. Lamer, M.D.</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>radiofrequency ablation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Radiofrequency Neurotomy Subjects</title>
          <description>Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Radiofrequency Neurotomy Subjects</title>
          <description>Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.8" lower_limit="27" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Procedures in Which Temperature of Screws Increased</title>
        <description>The study will measure for increased temperature in pedicle screws adjacent to lumbar facet joints during radiofrequency neurotomy (RFN). Temperatures will be recorded by placing a thermistor probe on the surface of the adjacent hardware.</description>
        <time_frame>2 hours</time_frame>
        <population>There were 6 participants, but some participants had more than 1 procedure. There were a total of 10 procedures analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Radiofrequency Neurotomy Subjects</title>
            <description>Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Procedures in Which Temperature of Screws Increased</title>
          <description>The study will measure for increased temperature in pedicle screws adjacent to lumbar facet joints during radiofrequency neurotomy (RFN). Temperatures will be recorded by placing a thermistor probe on the surface of the adjacent hardware.</description>
          <population>There were 6 participants, but some participants had more than 1 procedure. There were a total of 10 procedures analyzed.</population>
          <units>procedures</units>
          <param>Number</param>
          <units_analyzed>Procedures</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Procedures</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-significant increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Significant increase; procedure stopped</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collect during the procedure.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Radiofrequency Neurotomy Subjects</title>
          <description>Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Tim J. Lamer, M.D.</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507 778-8760</phone>
      <email>lamer.tim@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02210052
org study id: 14-003619
nct id: NCT02210052
lead sponsor: 
has dmc: No
The goal of the study was to determine if patients undergoing radiofrequency neurotomy (RFN)
      of lumbar facet joints that are adjacent to previously placed pedicle screws from a fusion,
      would lead to an increase in the temperature of the pedicle screws.
This study was a prospective clinical trial, examining outcomes related to temperature
      increases in pedicle screws. It was not possible to blind the investigators or the patient.
      Outcomes related temperature differences were collected at each pedicle screw adjacent to a
      zygapophyseal joint being treated.

      A conventional 18-gauge, 1-cm curved active tip radiofrequency cannula was placed under
      fluoroscopic guidance to the area to be treated (the junction of the transverse process and
      the superior articulating process of the facet joint). This position placed the tip of the
      radiofrequency cannula immediately adjacent to, but not in direct contact with, the pedicle
      screws. The radiofrequency cannula was connected to a radiofrequency generator, and the
      conventional settings for clinical medial branch neurotomy was used, heating the tissue to
      80°C for 90 seconds. The procedure described up to this point is the normal procedure and
      protocol for RFN performed at the Mayo Clinic.

      The experimental portion of the procedure is as follows: A separate 22 gauge radiofrequency
      cannula was intentionally placed in direct contact with the dorsal surface of the pedicle
      screws and was connected to a radiofrequency generator solely for the purpose of measuring
      temperature, as the RF cannula are dual purpose probes capable of both conducting energy for
      the radiofrequency lesion and monitoring tissue temperature. In other words, this small gauge
      needle was placed for the sole purpose of acting as a thermistor probe/temperature monitor.
      This process was repeated for each level necessary for treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Number of Procedures in Which Temperature of Screws Increased
time frame: 2 hours
description: The study will measure for increased temperature in pedicle screws adjacent to lumbar facet joints during radiofrequency neurotomy (RFN). Temperatures will be recorded by placing a thermistor probe on the surface of the adjacent hardware.
arm group label: Radiofrequency neurotomy subjects
arm group type: Experimental
description: Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
intervention type: Device
intervention name: Radiofrequency cannula
description: Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
arm group label: Radiofrequency neurotomy subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Tim J Lamer, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
citation: Gazelka HM, Welch TL, Nassr A, Lamer TJ. Safety of lumbar spine radiofrequency procedures in the presence of posterior pedicle screws: technical report of a cadaver study. Pain Med. 2015 May;16(5):877-80. doi: 10.1111/pme.12678. Epub 2015 Jan 8.
PMID: 25580992
citation: Lamer TJ, Smith J, Hoelzer BC, Mauck WD, Qu W, Gazelka HM. Safety of Lumbar Spine Radiofrequency Procedures in Patients Who Have Posterior Spinal Hardware. Pain Med. 2016 Sep;17(9):1634-7. doi: 10.1093/pm/pnv078. Epub 2016 Jan 13.
PMID: 26764338
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Tim J. Lamer, M.D.
investigator title: PI
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 