<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/NCT03018392</url>
  </required_header>
  <id_info>
    <org_study_id>TRITANIUM</org_study_id>
    <nct_id>NCT03018392</nct_id>
  </id_info>
  <brief_title>Clinical and Radiological Evaluation of Patients With DDD Following TLIF With 3-D Printed Titanium Cage</brief_title>
  <official_title>Fusion Rate and Clinical Outcomes Following 1 or 2 Level Open Transforaminal Lumbar Interbody Fusion for Degenerative Disc Disease With Novel 3-D Printed Titanium Cages With Pedicle Screw Fixation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bone and Joint Clinic of Baton Rouge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bone and Joint Clinic of Baton Rouge</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of&#xD;
      20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody&#xD;
      Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market&#xD;
      outcomes study to build on the body of long-term evidence for the device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 28, 2020</completion_date>
  <primary_completion_date type="Actual">January 28, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fusion Rate</measure>
    <time_frame>1 year</time_frame>
    <description>Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Intervertebral Disc Disease</condition>
  <arm_group>
    <arm_group_label>Tritanium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TLIF with Tritanium® PL cage and pedicle screw fixation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stryker Tritanium Spinal System</intervention_name>
    <description>open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications</description>
    <arm_group_label>Tritanium</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has one or more of the following diagnoses: degenerative disc disease (DDD) at&#xD;
             one level or two contiguous levels from L2 to S1, and may also include up to Grade I&#xD;
             spondylolisthesis at the involved level(s); degenerative scoliosis for which the&#xD;
             Tritanium PL cage will be used as an adjunct to fusion&#xD;
&#xD;
          -  Skeletally mature and ≥ 18 years old at time of enrollment&#xD;
&#xD;
          -  Completed at least 6 months of non-operative therapy prior to surgery&#xD;
&#xD;
          -  Willing and able to sign a study specific consent and comply with the requirements of&#xD;
             the protocol including follow up visits and imaging.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  2 levels requiring surgical intervention&#xD;
&#xD;
          -  Non-degenerative pathology including tumor, trauma, post-laminectomy kyphosis&#xD;
&#xD;
          -  Psudeoarthrosis at the index level&#xD;
&#xD;
          -  Previous fusion at the levels to be treated or at adjacent level&#xD;
&#xD;
          -  Any abnormality present which affects the normal process of bone remodeling including,&#xD;
             but not limited to, severe osteoporosis involving the spine, bone absorption,&#xD;
             osteopenia, primary or metastatic tumors involving the spine, active infection at the&#xD;
             site or certain metabolic disorders affecting osteogenesis.&#xD;
&#xD;
          -  History of osteoporotic fracture&#xD;
&#xD;
          -  History of an endocrine or metabolic disorder known to affect bone and mineral&#xD;
             metabolism&#xD;
&#xD;
          -  Inadequate tissue coverage over the operative site or taking medications that may&#xD;
             interfere with bony/soft tissue healing including chronic steroid use&#xD;
&#xD;
          -  Known allergy to titanium or cobalt chrome or may be sensitive to materials&#xD;
&#xD;
          -  Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV,&#xD;
             active hepatitis B or C or fibromyalgia&#xD;
&#xD;
          -  Lumbar kyphosis- lumbar lordosis &lt; 20°&#xD;
&#xD;
          -  Degenerative scoliosis &gt;20° OR any other pathology scoliosis (idiopathic, congenital,&#xD;
             posttraumatic, iatrogenic)&#xD;
&#xD;
          -  Active systemic infection or infection at the operative site&#xD;
&#xD;
          -  Marked local inflammation&#xD;
&#xD;
          -  Any open wounds&#xD;
&#xD;
          -  Pregnant, or intends to become pregnant during the study&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Subject is class 3 obese (BMI &gt;40) or overweight and can produce loads on the spinal&#xD;
             system which can lead to failure of the fixation of the device or to failure of the&#xD;
             device itself&#xD;
&#xD;
          -  Any mental or neuromuscular disorder which would create an unacceptable risk of&#xD;
             fixation failure or complications in postoperative care&#xD;
&#xD;
          -  Any neuromuscular deficit which places an unsafe load level on the device during the&#xD;
             healing period&#xD;
&#xD;
          -  Any other medical or surgical condition which would preclude the potential benefit of&#xD;
             spinal implant surgery, such as the presence of tumors, congenital abnormalities,&#xD;
             elevation of sedimentation rate unexplained by other diseases, elevation of white&#xD;
             blood cell count (WBC), or marked left shift in the WBC differential count.&#xD;
&#xD;
          -  Any condition of senility, mental illness, or substance abuse.&#xD;
&#xD;
          -  Involved in current spinal litigation that may interfere or influence patient&#xD;
             self-assessment of function and pain&#xD;
&#xD;
          -  Physical or mental condition that may interfere or influence patient self-assessment&#xD;
             of function and pain.&#xD;
&#xD;
          -  Incarcerated at the time of study enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chambliss Harrod, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bone and Joint Clinic of Baton Rouge</affiliation>
  </overall_official>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <results_first_submitted>July 19, 2022</results_first_submitted>
  <results_first_submitted_qc>August 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 7, 2022</results_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 26, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03018392/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tritanium</title>
          <description>TLIF with Tritanium® PL cage and pedicle screw fixation&#xD;
Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </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="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tritanium</title>
          <description>TLIF with Tritanium® PL cage and pedicle screw fixation&#xD;
Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.5" spread="7.8"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.6" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Fusion Rate</title>
        <description>Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion)</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tritanium</title>
            <description>TLIF with Tritanium® PL cage and pedicle screw fixation&#xD;
Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications</description>
          </group>
        </group_list>
        <measure>
          <title>Fusion Rate</title>
          <description>Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion)</description>
          <units>Participants</units>
          <param>Count of Participants</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>
                  <title>Fused</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pseudoarthrosis</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Progressing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tritanium</title>
          <description>TLIF with Tritanium® PL cage and pedicle screw fixation&#xD;
Stryker Tritanium Spinal System: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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>Extension of fusion</sub_title>
                <description>1 subject had a locked pseudoarthrosis with progressive isthmic spondylolisthesis at an adjacent level. This necessitated an extension of fusion.</description>
                <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>Non-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="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Cage Fracture</sub_title>
                <description>One incidental cage fracture in a setting of solid fusion was noted in the CT analysis. No intervention was necessary as the subject was doing well.</description>
                <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>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 for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Research Projects Director</name_or_title>
      <organization>Bone and Joint Clinic of Baton Rouge</organization>
      <phone>2254218207</phone>
      <email>aobrien@bjcbr.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/NCT03018392
org study id: TRITANIUM
nct id: NCT03018392
lead sponsor: 
The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of
      20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody
      Fusion (TLIF) with the Stryker Tritanium Spinal System. This is an on-label, post-market
      outcomes study to build on the body of long-term evidence for the device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fusion Rate
time frame: 1 year
description: Fusion status at 1 year post-operatively was graded as - fused (best outcome), progressing, or pseudoarthrosis (failed fusion)
arm group label: Tritanium
arm group type: Experimental
description: TLIF with Tritanium® PL cage and pedicle screw fixation
intervention type: Device
intervention name: Stryker Tritanium Spinal System
description: open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications
arm group label: Tritanium
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chambliss Harrod, MD
role: Principal Investigator
affiliation: Bone and Joint Clinic of Baton Rouge
responsible party type: Sponsor
mesh term: Spinal Diseases
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 