<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/NCT02969616</url>
  </required_header>
  <id_info>
    <org_study_id>CP-1504TEPL</org_study_id>
    <nct_id>NCT02969616</nct_id>
  </id_info>
  <brief_title>Trinity Elite in Lumbar Fusion</brief_title>
  <official_title>A Prospective, Post Market, Multi-center, Open Label, Non-Randomized Clinical Study of the Efficacy of Using Trinity ELITE in Lumbar Fusion Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orthofix Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orthofix Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, post-market, open label clinical study is designed to examine the lumbar&#xD;
      fusion rate at 24 months post operative in subjects who have undergone a lumbar fusion&#xD;
      surgery using Trinity Elite with or without local bone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, post-market, open label clinical study. Up to 10 sites across the&#xD;
      United States, with a minimum enrollment of 120 subjects study-wide, will be enrolling&#xD;
      subjects. The primary objective of this study is to measure the lumbar fusion rate in&#xD;
      subjects at 24 months when lumbar arthrodesis is performed using Trinity Elite with or&#xD;
      without local bone. Surgical approach (PLF, TLIF,ALIF, XLIF, etc.) is according to the&#xD;
      physician's discretion, but must comply with FDA approved/cleared indication for use and&#xD;
      labeling. The primary endpoints are radiographic evidence of fusion and the absence of&#xD;
      serious adverse events attributable to Trinity ELITE. The secondary objectives of this study&#xD;
      are to measure the clinical and economic outcomes when posterolateral arthrodesis is&#xD;
      performed using Trinity Elite and/or local bone with supplemental pedicle screw fixation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">February 2022</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>lumbar fusion by CT scan following arthrodesis using Trinity Elite</measure>
    <time_frame>24 months</time_frame>
    <description>CT scan of the lumbar vertebral column will be used to determine the fusion status of the spine after Trinity Elite was used in the lateral gutters and in the facet joints. The number of bridging bony cortices will be recorded by blinded reviewers and tabulated. The data will be reported as n</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of participants with treatment related adverse events</measure>
    <time_frame>24 months</time_frame>
    <description>AEs collected on an ongoing basis, reviewed by the Investigators and medical monitor</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Trinity Elite</intervention_name>
    <description>cell based allograft</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        age &gt;= 18 years of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be 18 years of age (≥ 18 years) or older at the time of consent.&#xD;
&#xD;
          2. Subject must have a documented diagnosis of DDD. DDD is defined by back and/or&#xD;
             radicular pain with degeneration of the disc as confirmed by medical history, physical&#xD;
             examination, and radiographic studies that may include CT, MRI, plain X-ray film,&#xD;
             discography, myelography, etc. with one or more of the following findings:&#xD;
&#xD;
               -  Instability as defined by &gt;3mm translation or &gt;5 degrees angulation&#xD;
&#xD;
               -  Osteophyte formation of facet joints or vertebral endplates&#xD;
&#xD;
               -  Decreased disc height, on average by &gt;2mm, but dependent upon the spinal level&#xD;
&#xD;
               -  Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint&#xD;
                  capsule&#xD;
&#xD;
               -  Herniated nucleus pulposus&#xD;
&#xD;
               -  Facet joint degeneration/changes; and/or&#xD;
&#xD;
               -  Vacuum phenomenon&#xD;
&#xD;
          3. Subject may have up to a Grade 2 Spondylolisthesis of the lumbar spine with clinical&#xD;
             manifestations of one or more of the following phenomena:&#xD;
&#xD;
               -  Radiculopathy&#xD;
&#xD;
               -  Sensory deficit&#xD;
&#xD;
               -  Motor weakness&#xD;
&#xD;
               -  Reflex changes&#xD;
&#xD;
          4. Subject must require lumbar arthrodesis at 1-4 contiguous levels (L1-S1) for a PLF&#xD;
             approach and 1-2 contiguous levels for an interbody approach.&#xD;
&#xD;
          5. Subject must have been unresponsive to conservative care for at least 6 months prior&#xD;
             to fusion surgery.&#xD;
&#xD;
        7. Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the&#xD;
        course of the study 8. Subject must be willing and able to sign an informed consent&#xD;
        document. 9. Subject must be willing and able to return for all follow-up visits, agree to&#xD;
        participate in postoperative clinical and radiographic evaluations and comply with the&#xD;
        required study regimen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is under 18 years of age (&lt;18) at the time of consent&#xD;
&#xD;
          2. Subject has had prior lumbar spine fusion surgery at any level&#xD;
&#xD;
          3. Subject has greater than grade 2 spondylolisthesis of the lumbar spine&#xD;
&#xD;
          4. Subject is currently undergoing treatment for malignancy or has undergone treatment&#xD;
             for malignancy in the past 5 years (benign skin cancer is permitted)&#xD;
&#xD;
          5. Subject is pregnant or nursing or planning to become pregnant during the two years (24&#xD;
             months) following arthrodesis&#xD;
&#xD;
          6. Subject has an active local or systemic infection or is undergoing adjunctive&#xD;
             treatment for local or systemic infection&#xD;
&#xD;
          7. Subject requires supplemental interbody arthrodesis.&#xD;
&#xD;
          8. Subject has an allergy to DMSO.&#xD;
&#xD;
          9. Subject is a prisoner.&#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>Alan Daniels, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Park, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beaumont Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fernando Techy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ClinTech Center for Spine Health</affiliation>
  </overall_official>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>August 10, 2021</last_update_submitted>
  <last_update_submitted_qc>August 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lumbar, fusion, DDD, Trinity Elite</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02969616
org study id: CP-1504TEPL
nct id: NCT02969616
lead sponsor: 
has dmc: No
This prospective, post-market, open label clinical study is designed to examine the lumbar
      fusion rate at 24 months post operative in subjects who have undergone a lumbar fusion
      surgery using Trinity Elite with or without local bone.
The study is a prospective, post-market, open label clinical study. Up to 10 sites across the
      United States, with a minimum enrollment of 120 subjects study-wide, will be enrolling
      subjects. The primary objective of this study is to measure the lumbar fusion rate in
      subjects at 24 months when lumbar arthrodesis is performed using Trinity Elite with or
      without local bone. Surgical approach (PLF, TLIF,ALIF, XLIF, etc.) is according to the
      physician's discretion, but must comply with FDA approved/cleared indication for use and
      labeling. The primary endpoints are radiographic evidence of fusion and the absence of
      serious adverse events attributable to Trinity ELITE. The secondary objectives of this study
      are to measure the clinical and economic outcomes when posterolateral arthrodesis is
      performed using Trinity Elite and/or local bone with supplemental pedicle screw fixation.
observational model: Cohort
time perspective: Prospective
measure: lumbar fusion by CT scan following arthrodesis using Trinity Elite
time frame: 24 months
description: CT scan of the lumbar vertebral column will be used to determine the fusion status of the spine after Trinity Elite was used in the lateral gutters and in the facet joints. The number of bridging bony cortices will be recorded by blinded reviewers and tabulated. The data will be reported as n
measure: number of participants with treatment related adverse events
time frame: 24 months
description: AEs collected on an ongoing basis, reviewed by the Investigators and medical monitor
intervention type: Biological
intervention name: Trinity Elite
description: cell based allograft
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alan Daniels, MD
role: Principal Investigator
affiliation: Brown University
last name: Daniel Park, MD
role: Principal Investigator
affiliation: Beaumont Hospital
last name: Fernando Techy, MD
role: Principal Investigator
affiliation: ClinTech Center for Spine Health
responsible party type: Sponsor
mesh term: Intervertebral Disc Degeneration
sharing ipd: Undecided