<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/NCT04416321</url>
  </required_header>
  <id_info>
    <org_study_id>KEOS01</org_study_id>
    <nct_id>NCT04416321</nct_id>
  </id_info>
  <brief_title>A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.</brief_title>
  <official_title>A Prospective, Non-comparative, Single-centre, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease in the Lumbar Spine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Invibio Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Keos LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Metrics Diagnostics, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Technomics Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Viedoc Technologies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Invibio Ltd</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to collect clinical outcomes including radiographic and CT&#xD;
      outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, non-comparative, single-center, post-market trial will evaluate the safety&#xD;
      and efficacy of the PEEK-OPTIMA ™ HA Enhanced Keos Lumbar Interbody Fusion Device in patients&#xD;
      suffering from degenerative disc disease, spondylolisthesis and retrolisthesis in the lumbar&#xD;
      spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month&#xD;
      period post operatively. One centre will be involved in the recruitment of 30 patients the&#xD;
      clinic involved will focus on this type of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2021</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>
    <intervention_model_description>All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interbody fusion rate</measure>
    <time_frame>6 months post - operatively</time_frame>
    <description>Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To measure how much pain the subject is in according to a pain scale 0-10</measure>
    <time_frame>6 weeks, 3, 6, 12 and 24 months post operatively</time_frame>
    <description>Visual analogue scale for back and leg 0-10 cm (no pain - worst possible pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12</measure>
    <time_frame>pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively</time_frame>
    <description>Questionnaire SF-12 collection of questions health related to assess vitality, physical functioning, bodily pain, general health perceptions, emotional and physical functioning, social and mental health. Patients will pick from a set list of answers for each health related question. The responses on each item are scored and summarised into Physical and Mental Health Composite Scores (PCS &amp; MCS) and range from 0-100. The lower the score the more disability. The higher the score the less disability i.e.a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Impairment</measure>
    <time_frame>pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively</time_frame>
    <description>Questionnaire ODI (Oswestry Disability Index) - disability questionnaire used to assess functional impairment of the patient. Regarding lifting, ability to walk, sit, stand, sleep, travel and graded by score of 0-100 (0= no disability and 100= maximum disability possible)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <condition>Spondylolisthesis</condition>
  <condition>Retrolisthesis</condition>
  <arm_group>
    <arm_group_label>Device</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surgery with the Keos Lumbar Interbody Fusion Device</intervention_name>
    <description>All subjects will received the Keos Lumbar Interbody Fusion Device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease, spondylolisthesis and retrolisthesis</description>
    <arm_group_label>Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 years of age or older.&#xD;
&#xD;
          2. Primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic&#xD;
             degenerative disc disease (DDD) with spondylolisthesis (Grade 1), or retrolisthesis,&#xD;
             at one or two contiguous levels from L2 to S1.&#xD;
&#xD;
          3. Have discogenic back pain.&#xD;
&#xD;
          4. Suitable for transforaminal lumbar interbody fusion (TLIF) surgery.&#xD;
&#xD;
          5. Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft.&#xD;
&#xD;
          6. Completed at least 6 months of conservative non-operative treatment.&#xD;
&#xD;
          7. Female subjects of childbearing age must have a negative pregnancy test.&#xD;
&#xD;
          8. Able to understand this clinical study, co-operate with procedures.&#xD;
&#xD;
          9. Able to give voluntary, written informed consent to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Not undergone previous spinal surgery at the affected disc level(s).&#xD;
&#xD;
          2. Evidence of tumour and/or malignant disease.&#xD;
&#xD;
          3. Known osteoporosis or severe osteopenia.&#xD;
&#xD;
          4. Known rheumatoid arthritis, ankylosing spondylitis or who are immunocompromised.&#xD;
&#xD;
          5. Known allergy to the material used in the instrumentation.&#xD;
&#xD;
          6. Evidence of an active infection.&#xD;
&#xD;
          7. Any conditions outlined as contraindicated in the Instructions for Use.&#xD;
&#xD;
          8. Receiving any drug treatment that may affect bone metabolism.&#xD;
&#xD;
          9. Female subjects who are pregnant or lactating.&#xD;
&#xD;
         10. Current smokers or have stopped smoking less than 6 months ago.&#xD;
&#xD;
         11. Known drug or alcohol abusers.&#xD;
&#xD;
         12. Currently enrolled in a clinical 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>
  <overall_official>
    <last_name>Louis A Marotti, M.D. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neurosurgical Associates of Lancaster</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karen Robson</last_name>
    <phone>+44 7765 220492</phone>
    <email>karen.robson@invibio.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sheryl O'Farrell</last_name>
    <phone>+44 7880024484</phone>
    <email>sheryl.ofarrell@invibio.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Neurosurgical Associates of Lancaster</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nichole Beaty</last_name>
      <phone>717-358-0800</phone>
      <phone_ext>215</phone_ext>
      <email>nbeaty@argiresmarotti.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 4, 2022</last_update_submitted>
  <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lumbar Degenerative Disc Disease</keyword>
  <keyword>Spondylolisthesis</keyword>
  <keyword>retrolisthesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04416321
org study id: KEOS01
nct id: NCT04416321
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this trial is to collect clinical outcomes including radiographic and CT
      outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
This prospective, non-comparative, single-center, post-market trial will evaluate the safety
      and efficacy of the PEEK-OPTIMA ™ HA Enhanced Keos Lumbar Interbody Fusion Device in patients
      suffering from degenerative disc disease, spondylolisthesis and retrolisthesis in the lumbar
      spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month
      period post operatively. One centre will be involved in the recruitment of 30 patients the
      clinic involved will focus on this type of treatment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device
primary purpose: Treatment
masking: None (Open Label)
measure: Interbody fusion rate
time frame: 6 months post - operatively
description: Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments
measure: To measure how much pain the subject is in according to a pain scale 0-10
time frame: 6 weeks, 3, 6, 12 and 24 months post operatively
description: Visual analogue scale for back and leg 0-10 cm (no pain - worst possible pain)
measure: To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12
time frame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
description: Questionnaire SF-12 collection of questions health related to assess vitality, physical functioning, bodily pain, general health perceptions, emotional and physical functioning, social and mental health. Patients will pick from a set list of answers for each health related question. The responses on each item are scored and summarised into Physical and Mental Health Composite Scores (PCS & MCS) and range from 0-100. The lower the score the more disability. The higher the score the less disability i.e.a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
measure: Functional Impairment
time frame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
description: Questionnaire ODI (Oswestry Disability Index) - disability questionnaire used to assess functional impairment of the patient. Regarding lifting, ability to walk, sit, stand, sleep, travel and graded by score of 0-100 (0= no disability and 100= maximum disability possible)
arm group label: Device
arm group type: Other
description: All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.
intervention type: Device
intervention name: Surgery with the Keos Lumbar Interbody Fusion Device
description: All subjects will received the Keos Lumbar Interbody Fusion Device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease, spondylolisthesis and retrolisthesis
arm group label: Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Louis A Marotti, M.D. PhD
role: Principal Investigator
affiliation: Neurosurgical Associates of Lancaster
last name: Karen Robson
phone: +44 7765 220492
email: karen.robson@invibio.com
last name: Sheryl O'Farrell
phone: +44 7880024484
email: sheryl.ofarrell@invibio.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Intervertebral Disc Degeneration
mesh term: Spondylolisthesis
sharing ipd: No