<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/NCT02184520</url>
  </required_header>
  <id_info>
    <org_study_id>PS090007/A10</org_study_id>
    <nct_id>NCT02184520</nct_id>
  </id_info>
  <brief_title>A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System</brief_title>
  <official_title>A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Globus Medical Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Globus Medical Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This postmarket surveillance study is being conducted to evaluate the TRANSITION&#xD;
      Stabilization System as an adjunct to fusion in the treatment of acute or chronic&#xD;
      instabilities or deformities of the thoracic, lumbar and sacral spine. The study will involve&#xD;
      up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION Stabilization&#xD;
      System. The data from this postmarket surveillance study will be provided to FDA in&#xD;
      accordance with the 522 order.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">April 19, 2016</start_date>
  <completion_date type="Actual">May 18, 2017</completion_date>
  <primary_completion_date type="Actual">October 20, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fusion Rates</measure>
    <time_frame>24 months</time_frame>
    <description>The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Acute Instabilities Thoracic, Lumbar and Sacral Spine</condition>
  <condition>Chronic Instabilities Thoracic, Lumbar and Sacral Spine</condition>
  <condition>Deformities of the Thoracic, Lumbar and Sacral Spine</condition>
  <arm_group>
    <arm_group_label>TRANSITION</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stabilization System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>REVERE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stabilization System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TRANSITION</intervention_name>
    <arm_group_label>TRANSITION</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>REVERE</intervention_name>
    <arm_group_label>REVERE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any of the following acute or chronic instabilities or deformities of the thoracic,&#xD;
             lumbar or sacral spine:&#xD;
&#xD;
          -  degenerative spondylolisthesis with objective evidence of neurologic impairment,&#xD;
&#xD;
          -  kyphosis, or&#xD;
&#xD;
          -  pseudoarthrosis (failed previous fusion)&#xD;
&#xD;
          -  Age 18 or older at the time of consent&#xD;
&#xD;
          -  Able to understand and sign informed consent form&#xD;
&#xD;
          -  Psychosocially, mentally and physically able to comply with protocol&#xD;
&#xD;
          -  Able to meet the proposed follow-up schedule at 6 mo, 12 mo, and 24 mo&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior fusion surgery or another spinal device implanted in the thoracic, lumbar or&#xD;
             sacral spine&#xD;
&#xD;
          -  Requires treatment of more than two vertebral levels&#xD;
&#xD;
          -  Lytic spondylolisthesis at the index level(s)&#xD;
&#xD;
          -  Clinically compromised vertebral bodies at the affected level(s) due to current or&#xD;
             past trauma&#xD;
&#xD;
          -  Sustained pathologic fractures of the spine or hip, including prior fracture or trauma&#xD;
             to vertebral structures at any thoracic, lumbar, or sacral level&#xD;
&#xD;
          -  Morbid obesity defined as a body mass index &gt; 40, or a weight more than 100 lbs over&#xD;
             ideal body weight&#xD;
&#xD;
          -  Pregnant or interested in becoming pregnant within the next 2 years&#xD;
&#xD;
          -  Active systemic or local infection&#xD;
&#xD;
          -  Known allergy to device materials titanium, polycarbonate (PCU), polyethylene&#xD;
             terepthalate (PET), or hydroxyapatite (HA).&#xD;
&#xD;
          -  Taking medications or any drug known to potentially interfere with bone/soft tissue&#xD;
             healing (e.g., steroids, excluding routine NSAIDs)&#xD;
&#xD;
          -  Systemic disease including AIDS, HIV, Hepatitis C&#xD;
&#xD;
          -  Has an active malignancy defined as a history of any invasive malignancy (except&#xD;
             non-melanoma skin cancer), unless he/she has been treated with curative intent and&#xD;
             there has been no clinical signs or symptoms of the malignancy for at least 5 years&#xD;
&#xD;
          -  Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy,&#xD;
             amyotrophic lateral sclerosis, etc.&#xD;
&#xD;
          -  Participation in an investigational device or drug clinical trials within 30 days of&#xD;
             surgery&#xD;
&#xD;
          -  Acute mental illness or substance abuse&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fort Wayne Orthopaedics</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>February 18, 2021</results_first_submitted>
  <results_first_submitted_qc>February 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2021</results_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2021</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>Aortic Dissection</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>TRANSITION</title>
          <description>Stabilization System&#xD;
TRANSITION</description>
        </group>
        <group group_id="P2">
          <title>REVERE</title>
          <description>Stabilization System&#xD;
REVERE</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.</population>
      <group_list>
        <group group_id="B1">
          <title>TRANSITION</title>
          <description>Stabilization System&#xD;
TRANSITION</description>
        </group>
        <group group_id="B2">
          <title>REVERE</title>
          <description>Stabilization System&#xD;
REVERE</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                </category>
                <category>
                  <title>Asian</title>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                </category>
                <category>
                  <title>Black or African American</title>
                </category>
                <category>
                  <title>White</title>
                </category>
                <category>
                  <title>More than one race</title>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Fusion Rates</title>
        <description>The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.</description>
        <time_frame>24 months</time_frame>
        <population>The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>TRANSITION</title>
            <description>Stabilization System&#xD;
TRANSITION</description>
          </group>
          <group group_id="O2">
            <title>REVERE</title>
            <description>Stabilization System&#xD;
REVERE</description>
          </group>
        </group_list>
        <measure>
          <title>Fusion Rates</title>
          <description>The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.</description>
          <population>The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months</time_frame>
      <desc>The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>TRANSITION</title>
          <description>Stabilization System</description>
        </group>
        <group group_id="E2">
          <title>REVERE</title>
          <description>Stabilization System</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jacqueline Myer</name_or_title>
      <organization>Globus Medical</organization>
      <phone>610-930-1800</phone>
      <email>jmyer@globusmedical.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/NCT02184520
org study id: PS090007/A10
nct id: NCT02184520
lead sponsor: 
has dmc: Yes
This postmarket surveillance study is being conducted to evaluate the TRANSITION
      Stabilization System as an adjunct to fusion in the treatment of acute or chronic
      instabilities or deformities of the thoracic, lumbar and sacral spine. The study will involve
      up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION Stabilization
      System. The data from this postmarket surveillance study will be provided to FDA in
      accordance with the 522 order.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fusion Rates
time frame: 24 months
description: The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.
arm group label: TRANSITION
arm group type: Active Comparator
description: Stabilization System
arm group label: REVERE
arm group type: Active Comparator
description: Stabilization System
intervention type: Device
intervention name: TRANSITION
arm group label: TRANSITION
intervention type: Device
intervention name: REVERE
arm group label: REVERE
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Aortic Dissection
mesh term: Congenital Abnormalities
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 