<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/NCT03817606</url>
  </required_header>
  <id_info>
    <org_study_id>RMC193</org_study_id>
    <nct_id>NCT03817606</nct_id>
  </id_info>
  <brief_title>A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant</brief_title>
  <official_title>A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant on Spinal Fusion in Patients With Degenerative Disc Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riverside Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stryker Spine</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Riverside Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare outcomes of patients with degenerative disc disease&#xD;
      undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF&#xD;
      PEEK implant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study protocol intends to examine the difference in efficacy between the Tritanium&#xD;
      Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to&#xD;
      achieve fusion of the spine. Study participants will undergo a transforaminal lumbar&#xD;
      interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree&#xD;
      to which fusion has been achieved. Survey methodology to assess perceived pain, level of&#xD;
      disability, and quality of life will also be used to measure the differences between groups&#xD;
      on these components.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to COVID-19 disruption&#xD;
  </why_stopped>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">April 27, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>
    <intervention_model_description>Parallel randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Study participants will not know which posterior lumbar cage they receive.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Fusion Success</measure>
    <time_frame>12 Months</time_frame>
    <description>CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Analogue Scale</measure>
    <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
    <description>Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Low Back Function</measure>
    <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
    <description>Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life: SF-36 PCS</measure>
    <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.</time_frame>
    <description>Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Return to Work</measure>
    <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
    <description>Subjects who were unable to work due to their back pain who return to work.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulatory Status</measure>
    <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
    <description>Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events</measure>
    <time_frame>6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
    <description>Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life: EQ-5d</measure>
    <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
    <description>Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <condition>Degenerative Scoliosis</condition>
  <arm_group>
    <arm_group_label>Tritanium Posterior Lumbar Cage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgical placement of the Tritanium Posterior Lumbar Cage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AVS PEEK UniLIF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tritanium Posterior Lumbar Cage</intervention_name>
    <description>Placement of Tritanium Posterior Lumbar Cage via TLIF procedure</description>
    <arm_group_label>Tritanium Posterior Lumbar Cage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AVS UniLIF PEEK Posterior Lumbar Cage</intervention_name>
    <description>Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.</description>
    <arm_group_label>AVS PEEK UniLIF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is skeletally mature&#xD;
&#xD;
          -  Subject has one or more of the following diagnoses:&#xD;
&#xD;
               1. Degenerative Disc Disease (DDD) at one level or two contiguous levels from L2 to&#xD;
                  S1&#xD;
&#xD;
                  a. DDD may include up to Grade 1 spondylolisthesis at the involved level(s)&#xD;
&#xD;
               2. Degenerative Scoliosis for which the interbody fusion device will be used as an&#xD;
                  adjunct to fusion&#xD;
&#xD;
          -  Subject has received 6 months of non-operative therapy&#xD;
&#xD;
          -  Subject understands the conditions of enrollment and is willing to sign and date the&#xD;
             Informed Consent&#xD;
&#xD;
          -  Subject agrees to comply with visit schedule and study assessments&#xD;
&#xD;
          -  Provision of signed and dated informed consent form&#xD;
&#xD;
          -  Subject stated willingness to comply with all study procedures and availability for&#xD;
             the duration of the study&#xD;
&#xD;
          -  Subject is in good general health as evidenced by medical history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is obese (BMI &gt; 40)&#xD;
&#xD;
          -  Subject is sensitive to titanium materials&#xD;
&#xD;
          -  Subject has an active infection at the operative site&#xD;
&#xD;
          -  Subject has marked local inflammation&#xD;
&#xD;
          -  Subject has any abnormality present which affects the normal process of bone&#xD;
             remodeling including, but not limited to, severe osteoporosis involving the spine,&#xD;
             bone absorption, osteopenia, tumors involving the spine, active infection at the site,&#xD;
             or certain metabolic disorders affecting osteogenesis&#xD;
&#xD;
          -  Subject has any mental, trauma, or neuromuscular disorder which would create an&#xD;
             unacceptable risk of fixation failure or complications in postoperative care&#xD;
&#xD;
          -  Subject has any open wounds&#xD;
&#xD;
          -  Subject is pregnant or plans to become pregnant during the course of the study&#xD;
&#xD;
          -  Subject has inadequate tissue coverage over the operative site.&#xD;
&#xD;
          -  Subject has an neuromuscular deficit which places an unsafe load on the device during&#xD;
             the healing period&#xD;
&#xD;
          -  Subject has any condition of senility, mental illness, or substance abuse&#xD;
&#xD;
          -  Subject has any other medical or surgical condition which would preclude the potential&#xD;
             benefit of spinal implant surgery, such as the presence of tumors, congenital&#xD;
             abnormalities, elevation of sedimentation rate unexplained by other diseases,&#xD;
             elevation of white blood cell count (WBC), or marked left shift in the WBC&#xD;
             differential count.&#xD;
&#xD;
          -  Subject has prior fusion at the levels to be treated&#xD;
&#xD;
          -  Subject is incarcerated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Zipsie</last_name>
    <role>Study Director</role>
    <affiliation>Riverside Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan Jimenez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riverside Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Riverside Medical Center</name>
      <address>
        <city>Kankakee</city>
        <state>Illinois</state>
        <zip>60901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <results_first_submitted>September 29, 2021</results_first_submitted>
  <results_first_submitted_qc>November 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 15, 2021</results_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Riverside Medical Center</investigator_affiliation>
    <investigator_full_name>Juan Jimenez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</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>September 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03817606/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03817606/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tritanium Posterior Lumbar Cage</title>
          <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure</description>
        </group>
        <group group_id="P2">
          <title>AVS PEEK UniLIF</title>
          <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </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="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AVS PEEK UniLIF</title>
          <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.&#xD;
Study not completed due to COVID-19</description>
        </group>
        <group group_id="B2">
          <title>Tritanium Posterior Lumbar Cage</title>
          <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure&#xD;
Study not completed due to COVID-19.</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="2"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="64" lower_limit="61" upper_limit="67"/>
                    <measurement group_id="B2" value="53.5" lower_limit="53" upper_limit="54"/>
                    <measurement group_id="B3" value="58.75" lower_limit="53" upper_limit="67"/>
                  </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 group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>Data collection was not completed as the study did not progress due to COVID-19</description>
          <population>The patients were enrolled; however, the study was not completed. No participants completed the study. There was no data to analyze.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Fusion Success</title>
        <description>CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint</description>
        <time_frame>12 Months</time_frame>
        <population>Four patients were initially enrolled; however, due to COVID-19, study enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No data to analyze.</population>
        <group_list>
          <group group_id="O1">
            <title>AVS PEEK UniLIF</title>
            <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.</description>
          </group>
          <group group_id="O2">
            <title>Tritanium Posterior Lumbar Cage</title>
            <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Fusion Success</title>
          <description>CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint</description>
          <population>Four patients were initially enrolled; however, due to COVID-19, study enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No data to analyze.</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>
        <type>Secondary</type>
        <title>Change in Visual Analogue Scale</title>
        <description>Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain.</description>
        <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
        <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</population>
        <group_list>
          <group group_id="O1">
            <title>AVS PEEK UniLIF</title>
            <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.&#xD;
Study not completed due to COVID-19</description>
          </group>
          <group group_id="O2">
            <title>Tritanium Posterior Lumbar Cage</title>
            <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure&#xD;
Study not completed due to COVID-19.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Visual Analogue Scale</title>
          <description>Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain.</description>
          <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</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>
        <type>Secondary</type>
        <title>Change in Low Back Function</title>
        <description>Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled).</description>
        <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
        <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</population>
        <group_list>
          <group group_id="O1">
            <title>Tritanium Posterior Lumbar Cage</title>
            <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure</description>
          </group>
          <group group_id="O2">
            <title>AVS PEEK UniLIF</title>
            <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Low Back Function</title>
          <description>Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled).</description>
          <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</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>
        <type>Secondary</type>
        <title>Change in Quality of Life: SF-36 PCS</title>
        <description>Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function).</description>
        <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.</time_frame>
        <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</population>
        <group_list>
          <group group_id="O1">
            <title>Tritanium Posterior Lumbar Cage</title>
            <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure</description>
          </group>
          <group group_id="O2">
            <title>AVS PEEK UniLIF</title>
            <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life: SF-36 PCS</title>
          <description>Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function).</description>
          <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</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>
        <type>Secondary</type>
        <title>Number of Participants That Return to Work</title>
        <description>Subjects who were unable to work due to their back pain who return to work.</description>
        <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
        <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</population>
        <group_list>
          <group group_id="O1">
            <title>Tritanium Posterior Lumbar Cage</title>
            <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure</description>
          </group>
          <group group_id="O2">
            <title>AVS PEEK UniLIF</title>
            <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Return to Work</title>
          <description>Subjects who were unable to work due to their back pain who return to work.</description>
          <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</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>
        <type>Secondary</type>
        <title>Ambulatory Status</title>
        <description>Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.</description>
        <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
        <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</population>
        <group_list>
          <group group_id="O1">
            <title>Tritanium Posterior Lumbar Cage</title>
            <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure</description>
          </group>
          <group group_id="O2">
            <title>AVS PEEK UniLIF</title>
            <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Ambulatory Status</title>
          <description>Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.</description>
          <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</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>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events</title>
        <description>Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation</description>
        <time_frame>6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
        <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</population>
        <group_list>
          <group group_id="O1">
            <title>Tritanium Posterior Lumbar Cage</title>
            <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure</description>
          </group>
          <group group_id="O2">
            <title>AVS PEEK UniLIF</title>
            <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events</title>
          <description>Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation</description>
          <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</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>
        <type>Secondary</type>
        <title>Change in Quality of Life: EQ-5d</title>
        <description>Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health.</description>
        <time_frame>Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation</time_frame>
        <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</population>
        <group_list>
          <group group_id="O1">
            <title>Tritanium Posterior Lumbar Cage</title>
            <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure</description>
          </group>
          <group group_id="O2">
            <title>AVS PEEK UniLIF</title>
            <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life: EQ-5d</title>
          <description>Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health.</description>
          <population>Four patients were initially enrolled; however due to COVID-19 enrollment was suspended and patient follow up was limited to standard of care. The study was not continued. No Data to Analyze</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>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tritanium Posterior Lumbar Cage</title>
          <description>Surgical placement of the Tritanium Posterior Lumbar Cage&#xD;
Tritanium Posterior Lumbar Cage: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure</description>
        </group>
        <group group_id="E2">
          <title>AVS PEEK UniLIF</title>
          <description>Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage&#xD;
AVS UniLIF PEEK Posterior Lumbar Cage: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.</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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </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>Cynthia Koehn, Clinical Research Nurse</name_or_title>
      <organization>Riverside Medical Center</organization>
      <phone>815-933-1671</phone>
      <email>ckoehn@rhc.net</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/NCT03817606
org study id: RMC193
nct id: NCT03817606
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to compare outcomes of patients with degenerative disc disease
      undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF
      PEEK implant.
This study protocol intends to examine the difference in efficacy between the Tritanium
      Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to
      achieve fusion of the spine. Study participants will undergo a transforaminal lumbar
      interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree
      to which fusion has been achieved. Survey methodology to assess perceived pain, level of
      disability, and quality of life will also be used to measure the differences between groups
      on these components.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel randomized controlled trial
primary purpose: Treatment
masking: Single (Participant)
masking description: Study participants will not know which posterior lumbar cage they receive.
measure: Number of Participants With Fusion Success
time frame: 12 Months
description: CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint
measure: Change in Visual Analogue Scale
time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
description: Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain.
measure: Change in Low Back Function
time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
description: Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled).
measure: Change in Quality of Life: SF-36 PCS
time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.
description: Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function).
measure: Number of Participants That Return to Work
time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
description: Subjects who were unable to work due to their back pain who return to work.
measure: Ambulatory Status
time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
description: Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.
measure: Number of Participants With Serious Adverse Events
time frame: 6 weeks; 3 months; 6 months; and 12 months post operation
description: Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation
measure: Change in Quality of Life: EQ-5d
time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
description: Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health.
arm group label: Tritanium Posterior Lumbar Cage
arm group type: Experimental
description: Surgical placement of the Tritanium Posterior Lumbar Cage
arm group label: AVS PEEK UniLIF
arm group type: Active Comparator
description: Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage
intervention type: Device
intervention name: Tritanium Posterior Lumbar Cage
description: Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
arm group label: Tritanium Posterior Lumbar Cage
intervention type: Device
intervention name: AVS UniLIF PEEK Posterior Lumbar Cage
description: Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
arm group label: AVS PEEK UniLIF
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Lisa Zipsie
role: Study Director
affiliation: Riverside Medical Center
last name: Juan Jimenez, MD
role: Principal Investigator
affiliation: Riverside Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Riverside Medical Center
investigator full name: Juan Jimenez
investigator title: Principal Investigator
mesh term: Scoliosis
mesh term: Intervertebral Disc Degeneration
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 