<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/NCT03761563</url>
  </required_header>
  <id_info>
    <org_study_id>1105 CL</org_study_id>
    <nct_id>NCT03761563</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease</brief_title>
  <acronym>FORTE</acronym>
  <official_title>Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease (FORTE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Surgalign Spine Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Surgalign Spine Technologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, non-randomized post-market evaluation designed to&#xD;
      collect and evaluate data on the safety and performance of the Fortilink IBF System with&#xD;
      TETRAfuse 3D Technology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, non-randomized post-market evaluation designed to&#xD;
      collect and evaluate data on the safety and performance of the Fortilink IBF System with&#xD;
      TETRAfuse 3D Technology.&#xD;
&#xD;
      There will be 3 arms in the study, one for each configuration of the Fortilink IBF system&#xD;
      (Fortilink-C, Fortilink-TS and Fortilink-L). Up to 50 subjects will be enrolled in each study&#xD;
      arm for a total of up to 150 subjects at up to 20 sites in the United States (US) and&#xD;
      European Union (EU).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 13, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Rate of cervical fusion evaluated by radiographic evidence</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of lumbar fusion evaluated by radiographic evidence</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain from baseline evaluated by use of subject-reported 100mm Visual Analogue Scale (VAS)</measure>
    <time_frame>1 month, 3 months, 6 months, 12 months, and 24 months</time_frame>
    <description>The VAS pain scale ranges from 0 to 100 where 0 represents No Pain and 100 represents Unbearable Pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic findings by CT evaluation</measure>
    <time_frame>12 months and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to return to work</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of serious device related adverse events</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of serious procedure related adverse events</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional ability determined by Neck Disability Index (NDI) or Oswestry Disability Index (ODI)</measure>
    <time_frame>3 months, 6 months, 12 months, and 24 months</time_frame>
    <description>The NDI is a subject questionnaire designed to assess neck pain and will only be completed by subjects who undergo cervical implants. The ODI is a subject questionnaire designed to assess back pain and will only be completed by subjects who undergo lumbar implants. Each questionnaire consists of a total score ranging from 0 to 100 where a lower score represents a better outcome and a higher score represents a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life determined by SF-12 questionnaire</measure>
    <time_frame>3 months, 6 months, 12 months, and 24 months</time_frame>
    <description>SF-12 questionnaires scores are computed and range from 0 to 100 where a 0 score indicates the lowest level of health and 100 indicates the highest level of health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain medication usage from baseline</measure>
    <time_frame>1 month, 3 months, 6 months, 12 months, and 24 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fortilink IBF System with TETRAfuse Technology</intervention_name>
    <description>Cervical and lumbar fusion</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects in this study will be candidates who undergo interbody fusion of hte spine due to&#xD;
        degenerative disc disease using the Fortilink IBF device.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject is skeletally mature and at least 18 years of age.&#xD;
&#xD;
          -  The subject has degenerative disc disease (DDD) of the cervical spine with&#xD;
             accompanying radicular symptom at one or two contiguous levels (Fortilink-C), or the&#xD;
             subject has DDD and ≤ Grade 1 spondylolisthesis of the lumbar spine at one or two&#xD;
             contiguous levels (Fortilink-TS and Fortilink-L).&#xD;
&#xD;
          -  Subject plans to undergo one of the following procedures:&#xD;
&#xD;
        An anterior cervical interbody fusion at one to two continuous levels from C2-C3 to C7-T1&#xD;
        using autogenous or allogenic bone graft and supplemental fixation cleared and indicated&#xD;
        for use at the proposed treatment level(s) (Fortilink-C), or&#xD;
&#xD;
        An interbody fusion in the lumbar spine at one to two continuous levels from L1-L2 to L5-S1&#xD;
        using autogenous or allogenic bone graft and supplemental fixation cleared and indicated&#xD;
        for use at the proposed treatment level(s) (Fortilink-TS and Fortilink-L).&#xD;
&#xD;
          -  The subject has undergone non-operative treatment of at least six weeks (Fortilink-C)&#xD;
             or at least six months (Fortilink-TS and Fortilink-L) prior to treatment with the IBF&#xD;
             system.&#xD;
&#xD;
          -  The subject is willing and able to provide informed consent.&#xD;
&#xD;
          -  The subject is willing and able to attend the protocol required follow-up visits and&#xD;
             examinations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has an active infection&#xD;
&#xD;
          -  The subject has had prior fusion attempt(s) or is undergoing revision of a previously&#xD;
             implanted system at the involved level(s).&#xD;
&#xD;
          -  The subject is a worker's compensation case, in active litigation related to the&#xD;
             procedure or is a prisoner or ward of the state.&#xD;
&#xD;
          -  The subject meets one or more of the contraindications outlined in the IFU.&#xD;
&#xD;
          -  The subject is pregnant, nursing, or is planning to become pregnant in the next year.&#xD;
&#xD;
          -  The subject has documented evidence of current substance abuse.&#xD;
&#xD;
          -  The subject has other concurrent medical condition that, in the opinion of the&#xD;
             investigator, does not make the subject a good candidate for the study.&#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>Los Angeles Orthopedic Institute</name>
      <address>
        <city>Sherman Oaks</city>
        <state>California</state>
        <zip>91403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Spine Clinic</name>
      <address>
        <city>Lone Tree</city>
        <state>Colorado</state>
        <zip>80124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medstar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Back Institute</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33496</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Spine &amp; Orthopaedics</name>
      <address>
        <city>Coconut Creek</city>
        <state>Florida</state>
        <zip>33073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spine Institute of South Florida</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Spine Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>47905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Institute of Western Kentucky</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoBethesda</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vittorio M. Morreale, MD, PLC</name>
      <address>
        <city>Shelby</city>
        <state>Michigan</state>
        <zip>48315</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ReVive Spine Center</name>
      <address>
        <city>Niagara Falls</city>
        <state>New York</state>
        <zip>14304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lindner Center for Research &amp; Education at The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rothman Orthopaedic Institute</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spine MD</name>
      <address>
        <city>North Richland Hills</city>
        <state>Texas</state>
        <zip>76182</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwood Ortho-Spine</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77382</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</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>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
  </condition_browse>
  <!-- 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/NCT03761563
org study id: 1105 CL
nct id: NCT03761563
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multi-center, non-randomized post-market evaluation designed to
      collect and evaluate data on the safety and performance of the Fortilink IBF System with
      TETRAfuse 3D Technology.
This is a prospective, multi-center, non-randomized post-market evaluation designed to
      collect and evaluate data on the safety and performance of the Fortilink IBF System with
      TETRAfuse 3D Technology.

      There will be 3 arms in the study, one for each configuration of the Fortilink IBF system
      (Fortilink-C, Fortilink-TS and Fortilink-L). Up to 50 subjects will be enrolled in each study
      arm for a total of up to 150 subjects at up to 20 sites in the United States (US) and
      European Union (EU).
observational model: Cohort
time perspective: Prospective
measure: Rate of cervical fusion evaluated by radiographic evidence
time frame: 12 months
measure: Rate of lumbar fusion evaluated by radiographic evidence
time frame: 24 months
measure: Change in pain from baseline evaluated by use of subject-reported 100mm Visual Analogue Scale (VAS)
time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
description: The VAS pain scale ranges from 0 to 100 where 0 represents No Pain and 100 represents Unbearable Pain.
measure: Radiographic findings by CT evaluation
time frame: 12 months and 24 months
measure: Time to return to work
time frame: up to 24 months
measure: Incidence of serious device related adverse events
time frame: up to 24 months
measure: Incidence of serious procedure related adverse events
time frame: up to 24 months
measure: Change in functional ability determined by Neck Disability Index (NDI) or Oswestry Disability Index (ODI)
time frame: 3 months, 6 months, 12 months, and 24 months
description: The NDI is a subject questionnaire designed to assess neck pain and will only be completed by subjects who undergo cervical implants. The ODI is a subject questionnaire designed to assess back pain and will only be completed by subjects who undergo lumbar implants. Each questionnaire consists of a total score ranging from 0 to 100 where a lower score represents a better outcome and a higher score represents a worse outcome.
measure: Change in quality of life determined by SF-12 questionnaire
time frame: 3 months, 6 months, 12 months, and 24 months
description: SF-12 questionnaires scores are computed and range from 0 to 100 where a 0 score indicates the lowest level of health and 100 indicates the highest level of health.
measure: Change in pain medication usage from baseline
time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
intervention type: Device
intervention name: Fortilink IBF System with TETRAfuse Technology
description: Cervical and lumbar fusion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Spinal Diseases
mesh term: Intervertebral Disc Degeneration