<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/NCT02203448</url>
  </required_header>
  <id_info>
    <org_study_id>CT13/01</org_study_id>
    <nct_id>NCT02203448</nct_id>
  </id_info>
  <brief_title>Facet Wedge Post Market Study</brief_title>
  <official_title>A Multi-centre, Prospective, Single-arm Post Market Clinical Follow up Study (PMCF) of the FACET WEDGE Spinal System to Assess Outcomes in Subjects With Chronic Low Back Pain Due to Degenerative Disc Disease (DDD), Facet Joint Disease and/or Pseudo Arthrosis Post Anterior Instrumentation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Synthes GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Synthes GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the&#xD;
      FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to&#xD;
      Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior&#xD;
      instrumentation. The objective of this study is to assess outcomes following implantation of&#xD;
      the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments.&#xD;
&#xD;
      The primary objective of this study is to determine the rate of re-operations at the index&#xD;
      level(s).&#xD;
&#xD;
      The secondary objectives of this study are to confirm the safety and performance of the&#xD;
      device and to collect patient reported outcome data.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2014</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>reoperation rate at the index level(s)</measure>
    <time_frame>at two years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the radiographic range of motion (ROM) at the index levels</measure>
    <time_frame>Pre-treatment, 6 months, 12 months, 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient (back and leg) pain reported on a Numeric Rating Scale (NRS)</measure>
    <time_frame>pre-treatment, prior to D/C, 6 weeks, 6 months, 12 months, 24 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional success based on results from the Oswestry Disability Index (ODI)</measure>
    <time_frame>Pre-treatment, 6 weeks, 6 months, 12 months, 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Throughout the study</time_frame>
    <description>The nature and incidence of all procedural and post-treatment adverse events will be recorded and reported appropriately throughout the study to assess safety.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <condition>Degenerative Disc Disease</condition>
  <condition>Facet Joint Disease</condition>
  <condition>Pseudo Arthrosis Post Anterior Instrumentation</condition>
  <arm_group>
    <arm_group_label>FACET WEDGE spinal system</arm_group_label>
    <description>The FACET WEDGE spinal system provides additional stability to a spinal segment to enhance fusion conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Facet Wedge spinal system</intervention_name>
    <arm_group_label>FACET WEDGE spinal system</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The cases in the cohort are selected from patients treated in hospitals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects diagnosed with at least one of the following:&#xD;
&#xD;
               -  Degenerative Disc Disease (DDD);&#xD;
&#xD;
               -  Degenerative facet joint disease (isolated facet based symptomatic back pain);&#xD;
&#xD;
               -  Pseudoarthrosis post anterior instrumentation;&#xD;
&#xD;
          2. Subjects who are a fusion candidate for single or multiple levels fusion between&#xD;
             L1-S1;&#xD;
&#xD;
          3. Subjects, who, in the opinion of the Investigator, are able to understand this&#xD;
             clinical investigation, co-operate with the investigational procedures and are willing&#xD;
             to return to the hospital for all the required post-operative follow-ups.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Preoperative exclusion criteria:&#xD;
&#xD;
          1. Segmental instability of the index level in case of planned stand-alone FACET WEDGE&#xD;
             usage;&#xD;
&#xD;
          2. Unilateral application , except in combination with pediclescrew fixation on the&#xD;
             contralateral side;&#xD;
&#xD;
          3. Compromised facets due to decompression techniques;&#xD;
&#xD;
          4. Spondylolisthesis;&#xD;
&#xD;
          5. Fracture or other instabilities of the posterior elements;&#xD;
&#xD;
          6. Tumor;&#xD;
&#xD;
          7. Acute or chronic systemic or localized spinal infections;&#xD;
&#xD;
          8. Nursing mothers or women who are pregnant or plan to become pregnant during the time&#xD;
             of the study;&#xD;
&#xD;
          9. Subjects aged below 18 years;&#xD;
&#xD;
         10. Subjects who, in the opinion of the Investigator, have an existing condition that&#xD;
             would compromise their participation and follow-up in this clinical investigation;&#xD;
&#xD;
             Intraoperative exclusion criteria:&#xD;
&#xD;
         11. Intraoperative decision to use implants other than the device under investigation.&#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>Frank Kandziora, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BG Unfallklinik</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60439</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schon Klinik Munchen</name>
      <address>
        <city>Munchen</city>
        <zip>81547</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UVN</name>
      <address>
        <city>Ruzomberok</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Slovakia</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>October 18, 2018</last_update_submitted>
  <last_update_submitted_qc>October 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2018</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>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Pseudarthrosis</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/NCT02203448
org study id: CT13/01
nct id: NCT02203448
lead sponsor: 
has dmc: Yes
A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the
      FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to
      Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior
      instrumentation. The objective of this study is to assess outcomes following implantation of
      the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments.

      The primary objective of this study is to determine the rate of re-operations at the index
      level(s).

      The secondary objectives of this study are to confirm the safety and performance of the
      device and to collect patient reported outcome data.
observational model: Cohort
time perspective: Prospective
measure: reoperation rate at the index level(s)
time frame: at two years
measure: the radiographic range of motion (ROM) at the index levels
time frame: Pre-treatment, 6 months, 12 months, 24 months
measure: patient (back and leg) pain reported on a Numeric Rating Scale (NRS)
time frame: pre-treatment, prior to D/C, 6 weeks, 6 months, 12 months, 24 months.
measure: functional success based on results from the Oswestry Disability Index (ODI)
time frame: Pre-treatment, 6 weeks, 6 months, 12 months, 24 months
measure: Adverse events
time frame: Throughout the study
description: The nature and incidence of all procedural and post-treatment adverse events will be recorded and reported appropriately throughout the study to assess safety.
arm group label: FACET WEDGE spinal system
description: The FACET WEDGE spinal system provides additional stability to a spinal segment to enhance fusion conditions.
intervention type: Device
intervention name: Facet Wedge spinal system
arm group label: FACET WEDGE spinal system
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frank Kandziora, PhD
role: Principal Investigator
affiliation: Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany
facility: 
facility: 
facility: 
country: Germany
country: Slovakia
responsible party type: Sponsor
mesh term: Intervertebral Disc Degeneration
mesh term: Joint Diseases
mesh term: Osteoarthritis
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Pseudarthrosis