<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/NCT03015142</url>
  </required_header>
  <id_info>
    <org_study_id>XCY607-130099</org_study_id>
    <nct_id>NCT03015142</nct_id>
  </id_info>
  <brief_title>Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions</brief_title>
  <official_title>Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Clinical &amp; Medical Affairs Global</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Clinical &amp; Medical Affairs Global</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>
      There is a clear need in spine surgery to place pedicle screws in the right place in the&#xD;
      spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or&#xD;
      vertebral arteries). The objective of the study was to investigate the accuracy of screw&#xD;
      placement during spine surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2016</start_date>
  <completion_date type="Actual">October 8, 2017</completion_date>
  <primary_completion_date type="Actual">October 8, 2017</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software</measure>
    <time_frame>During surgery, mean 6.71 hours</time_frame>
    <description>Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification.&#xD;
Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach &lt; 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach &gt; 4 mm.&#xD;
Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure Time</measure>
    <time_frame>During surgery, mean 6.71 hours</time_frame>
    <description>Time from skin incision to skin closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Insert Pedicle Screw</measure>
    <time_frame>Intraoperative, mean 5.18 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospitalization</measure>
    <time_frame>From start of the interventional procedure until hospital discharge, approximately 5.3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>System Usability Score (SUS Score)</measure>
    <time_frame>End of all surgeries</time_frame>
    <description>The SUS is a validated standard questionnaire to evaluate the system usability. Score varies between 0 and 100 (0 meaning the lowest usability score, 100 meaning highest usability score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Radiation Dose</measure>
    <time_frame>During surgery, mean 6.71 hours</time_frame>
    <description>Radiation dose measured in Air Kerma (AK)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Radiation Dose</measure>
    <time_frame>During surgery, mean 6.71 hours</time_frame>
    <description>Radiation dose measured in Dose Area Product (DAP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose (Effective Dose) Received by Operator</measure>
    <time_frame>During surgery, mean 6.71 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Related Complications</measure>
    <time_frame>During surgery, mean 6.71 hours</time_frame>
    <description>Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event</measure>
    <time_frame>From start of enrollment until hospital discharge, approximately 51 days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Spinal Diseases</condition>
  <arm_group>
    <arm_group_label>New image-guidance software</arm_group_label>
    <description>Patients in this group had spine surgery with new image-guidance software application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>New image-guidance software</intervention_name>
    <description>Patients in this group had spine surgery with new image-guidance software application</description>
    <arm_group_label>New image-guidance software</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients &gt; 16 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject undergoing a spine surgery with pedicle screw placement&#xD;
&#xD;
          -  Subject 16 years of age or older&#xD;
&#xD;
          -  Subject able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject participating in a potentially confounding device or drug trial during the&#xD;
             course of the study.&#xD;
&#xD;
          -  Subject meeting an exclusion criteria according to national law (e.g. pregnant woman,&#xD;
             breast feeding woman)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrian Elmi-Terander, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>https://journals.lww.com/spinejournal/Abstract/publishahead/Pedicle_Screw_Placement_Using_Augmented_Reality.94855.aspx</url>
    <description>Pedicle Screw Placement Using Augmented Reality Surgical Navigation with Intraoperative 3D Imaging. A First In-Human Prospective Cohort Study.</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>July 22, 2019</results_first_submitted>
  <results_first_submitted_qc>September 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 30, 2019</results_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2022</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>Spinal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 4, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03015142/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03015142/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>New Image-guidance Software</title>
          <description>Patients who had spine surgery with new image-guidance software.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>New Image-guidance Software</title>
          <description>Patients who had spine surgery with new image-guidance software</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </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>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software</title>
        <description>Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification.&#xD;
Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach &lt; 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach &gt; 4 mm.&#xD;
Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers.</description>
        <time_frame>During surgery, mean 6.71 hours</time_frame>
        <population>20 subjects were treated with the new image-guidance software. One was treated in the conventional method placing screws by free-hand method.&#xD;
Total of 253 screws (163 in thoracic, 77 in lumbar and 13 in sacral regions) were placed with new image-guidance software.</population>
        <group_list>
          <group group_id="O1">
            <title>New Image-guidance Software</title>
            <description>Patients who had spine surgery with new image-guidance software</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software</title>
          <description>Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification.&#xD;
Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach &lt; 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach &gt; 4 mm.&#xD;
Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers.</description>
          <population>20 subjects were treated with the new image-guidance software. One was treated in the conventional method placing screws by free-hand method.&#xD;
Total of 253 screws (163 in thoracic, 77 in lumbar and 13 in sacral regions) were placed with new image-guidance software.</population>
          <units>Percentage of screw placements</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Screw placements</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Screw placements</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="253"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.1" lower_limit="90.4" upper_limit="96.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Time</title>
        <description>Time from skin incision to skin closure</description>
        <time_frame>During surgery, mean 6.71 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>New Image-guidance Software</title>
            <description>Patients who had spine surgery with new image-guidance software</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Time</title>
          <description>Time from skin incision to skin closure</description>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.71" spread="1.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Insert Pedicle Screw</title>
        <time_frame>Intraoperative, mean 5.18 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>New Image-guidance Software</title>
            <description>Patients who had spine surgery with new image-guidance software</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Insert Pedicle Screw</title>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.18" spread="4.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospitalization</title>
        <time_frame>From start of the interventional procedure until hospital discharge, approximately 5.3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>New Image-guidance Software</title>
            <description>Patients who had spine surgery with new image-guidance software</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospitalization</title>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>System Usability Score (SUS Score)</title>
        <description>The SUS is a validated standard questionnaire to evaluate the system usability. Score varies between 0 and 100 (0 meaning the lowest usability score, 100 meaning highest usability score).</description>
        <time_frame>End of all surgeries</time_frame>
        <population>Four independent physicians provided feedback via a validated system usability score (SUS)</population>
        <group_list>
          <group group_id="O1">
            <title>New Image-guidance Software</title>
            <description>Patients who had spine surgery with new image-guidance software</description>
          </group>
        </group_list>
        <measure>
          <title>System Usability Score (SUS Score)</title>
          <description>The SUS is a validated standard questionnaire to evaluate the system usability. Score varies between 0 and 100 (0 meaning the lowest usability score, 100 meaning highest usability score).</description>
          <population>Four independent physicians provided feedback via a validated system usability score (SUS)</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.6" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Radiation Dose</title>
        <description>Radiation dose measured in Air Kerma (AK)</description>
        <time_frame>During surgery, mean 6.71 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>New Image-guidance Software</title>
            <description>Patients who had spine surgery with new image-guidance software</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Radiation Dose</title>
          <description>Radiation dose measured in Air Kerma (AK)</description>
          <units>mGy (AK)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158.60" spread="71.014"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Radiation Dose</title>
        <description>Radiation dose measured in Dose Area Product (DAP)</description>
        <time_frame>During surgery, mean 6.71 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>New Image-guidance Software</title>
            <description>Patients who had spine surgery with new image-guidance software</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Radiation Dose</title>
          <description>Radiation dose measured in Dose Area Product (DAP)</description>
          <units>Gy.cm^2 (DAP)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.26" spread="12.604"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiation Dose (Effective Dose) Received by Operator</title>
        <time_frame>During surgery, mean 6.71 hours</time_frame>
        <population>There were 2 cases out of the 20 patients were the dosage information was missing.</population>
        <group_list>
          <group group_id="O1">
            <title>New Image-guidance Software</title>
            <description>Patients who had spine surgery with new image-guidance software</description>
          </group>
        </group_list>
        <measure>
          <title>Radiation Dose (Effective Dose) Received by Operator</title>
          <population>There were 2 cases out of the 20 patients were the dosage information was missing.</population>
          <units>μSv</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="0.261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Related Complications</title>
        <description>Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).</description>
        <time_frame>During surgery, mean 6.71 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>New Image-guidance Software</title>
            <description>Patients who had spine surgery with new image-guidance software.</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Related Complications</title>
          <description>Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).</description>
          <units>Procedure related complications</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event</title>
        <time_frame>From start of enrollment until hospital discharge, approximately 51 days</time_frame>
        <population>21 patients enrolled, 20 patients treated with new image-guidance software</population>
        <group_list>
          <group group_id="O1">
            <title>New Image-guidance Software</title>
            <description>Patients who had spine surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event</title>
          <population>21 patients enrolled, 20 patients treated with new image-guidance software</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse Events (serious and non-serious)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse Device Effects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Device deficiencies that could have led to SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of enrollment until hospital discharge, approximately 51 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>New Image-guidance Software</title>
          <description>Patients who had spine surgery with new image-guidance software</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Pain right leg due to foramina stenosis by L5 screw. Screw was placed by free-hand.</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Horner's syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Postoperative pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Repeated Xper-CT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Rami Nachabe</name_or_title>
      <organization>Philips</organization>
      <phone>+1-513-926-1486</phone>
      <email>rami.nachabe@philips.com</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/NCT03015142
org study id: XCY607-130099
nct id: NCT03015142
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is a clear need in spine surgery to place pedicle screws in the right place in the
      spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or
      vertebral arteries). The objective of the study was to investigate the accuracy of screw
      placement during spine surgery.
observational model: Cohort
time perspective: Prospective
measure: Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software
time frame: During surgery, mean 6.71 hours
description: Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification.
Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach < 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach > 4 mm.
Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers.
measure: Procedure Time
time frame: During surgery, mean 6.71 hours
description: Time from skin incision to skin closure
measure: Time to Insert Pedicle Screw
time frame: Intraoperative, mean 5.18 hours
measure: Length of Hospitalization
time frame: From start of the interventional procedure until hospital discharge, approximately 5.3 days
measure: System Usability Score (SUS Score)
time frame: End of all surgeries
description: The SUS is a validated standard questionnaire to evaluate the system usability. Score varies between 0 and 100 (0 meaning the lowest usability score, 100 meaning highest usability score).
measure: Patient Radiation Dose
time frame: During surgery, mean 6.71 hours
description: Radiation dose measured in Air Kerma (AK)
measure: Patient Radiation Dose
time frame: During surgery, mean 6.71 hours
description: Radiation dose measured in Dose Area Product (DAP)
measure: Radiation Dose (Effective Dose) Received by Operator
time frame: During surgery, mean 6.71 hours
measure: Procedure Related Complications
time frame: During surgery, mean 6.71 hours
description: Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).
measure: Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event
time frame: From start of enrollment until hospital discharge, approximately 51 days
arm group label: New image-guidance software
description: Patients in this group had spine surgery with new image-guidance software application.
intervention type: Device
intervention name: New image-guidance software
description: Patients in this group had spine surgery with new image-guidance software application
arm group label: New image-guidance software
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Adrian Elmi-Terander, MD
role: Principal Investigator
affiliation: Karolinska University Hospital
facility: 
country: Sweden
url: https://journals.lww.com/spinejournal/Abstract/publishahead/Pedicle_Screw_Placement_Using_Augmented_Reality.94855.aspx
description: Pedicle Screw Placement Using Augmented Reality Surgical Navigation with Intraoperative 3D Imaging. A First In-Human Prospective Cohort Study.
responsible party type: Sponsor
mesh term: Spinal Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 