<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/NCT03302520</url>
  </required_header>
  <id_info>
    <org_study_id>Nvmax_001</org_study_id>
    <nct_id>NCT03302520</nct_id>
  </id_info>
  <brief_title>Comparison of Bioactive Glass Ceramics Spacer and PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, RCT</brief_title>
  <acronym>Novomax</acronym>
  <official_title>Comparison of Fusion Rate and Clinical Results Between Bioactive Glass Ceramics Spacer With PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, Randomized Controlled Non-inferiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass&#xD;
      ceramics with PEEK cage that is widely used for posterior lumbar interbody fusion (PLIF)&#xD;
      surgery in the clinical field.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 28, 2017</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 11, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fusion rates</measure>
    <time_frame>up to 5 year after operation</time_frame>
    <description>This is assessed by postoperative computed tomography at 1 year after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Pain Scale (VAS)</measure>
    <time_frame>3, 6, and 12, months, and every year, up to 5 year after operation</time_frame>
    <description>VAS is a measurement score that indicates pain severity status. VAS score comprised a 10-cm line with ''none'' (0) on one end of the scale and ''disabling pain'' (10) on the other.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>3, 6, and 12, months, and every year, up to 5 year after operation</time_frame>
    <description>The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale.20 The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>3, 6, and 12, months, and every year, up to 5 year after operation</time_frame>
    <description>EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PainDETECT</measure>
    <time_frame>3, 6, and 12, months, and every year, up to 5 year after operation</time_frame>
    <description>The painDETECT Questionnaire (PDQ) is a screening tool designed to detect neuropathic pain in patients with chronic low back pain (LBP) based on self-reported pain characteristics. The degree of the seven types of pain quality, the type of pain pattern, and the presence of radiating pain. From the three components of the PDQ, a total score is calculated; a high score indicates that the pain is likely to have a neuropathic component. Scoring is performed using a scoring manual, and results in a final screening score: a score of 0-12 indicates nociceptive pain, 19-38 indicates neuropathic pain, and 13-18 indicates mixed pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fusion rates</measure>
    <time_frame>every year, up to 5 year after operation</time_frame>
    <description>This is assessed by postoperative simple radiography at 1 year after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>every year, up to 5 year after operation</time_frame>
    <description>Device related adverse events (fracture, translation, subsidence, osteolysis), Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Operation duration</measure>
    <time_frame>Immediate after operation</time_frame>
    <description>Intraoperative time</description>
  </other_outcome>
  <other_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>Immediate after operation</time_frame>
    <description>Intraoperative blood loss</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative drainage</measure>
    <time_frame>Within 3 days after operation</time_frame>
    <description>Total drainage after surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Amount of transfusion</measure>
    <time_frame>Within 7 days after operation</time_frame>
    <description>Total transfusion during and after surgery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Degenerative Lumbar Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>Novomax</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Novomax(R) ceramic glass spacer for interbody fusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEEK cage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PEEK cage for interbody fusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NovoMax, BioAlpha Inc, Seong-nam, Korea</intervention_name>
    <description>CaO-SiO2-P2O5-B2O3 glass ceramics spacer</description>
    <arm_group_label>Novomax</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEEK cage</intervention_name>
    <description>PEEK cage</description>
    <arm_group_label>PEEK cage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged between 30 and 80&#xD;
&#xD;
          -  patients who required one-level PLIF between L1 and S1 among those who required an&#xD;
             extensive laminectomy or facetectomy to correct severe disc extrusion or severe spinal&#xD;
             stenosis or those who required PLIF due to grade I or II spondylolisthesis&#xD;
&#xD;
          -  those who (only if a signature was obtainable), or whose legal guardian, fully&#xD;
             understood the clinical trial details and signed the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  osteoporosis patients with average T-scores of L1-L4 at &lt;-3.0 in DEXA bone density&#xD;
             tests&#xD;
&#xD;
          -  women with positive pregnancy tests before the trial or who planned to become pregnant&#xD;
             within the following 3 years&#xD;
&#xD;
          -  patients with a history of malignant tumor or malignant diseases (but the cases of&#xD;
             cured disease with no relapse for the past 5 years were included in the present study)&#xD;
&#xD;
          -  patients with abnormal blood potassium and phosphorus levels;&#xD;
&#xD;
          -  patients with liver disease, kidney disease, respiratory disease, metabolic disease,&#xD;
             or psychological disease;&#xD;
&#xD;
          -  patients deemed to have less than 1-year life expectancy;&#xD;
&#xD;
          -  patients with mental retardation or whose parents or legal guardians were older or had&#xD;
             mental disabilities;&#xD;
&#xD;
          -  other patients viewed as inappropriate by the staff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyounggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin S. Yeom</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</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/NCT03302520
org study id: Nvmax_001
nct id: NCT03302520
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass
      ceramics with PEEK cage that is widely used for posterior lumbar interbody fusion (PLIF)
      surgery in the clinical field.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Fusion rates
time frame: up to 5 year after operation
description: This is assessed by postoperative computed tomography at 1 year after surgery
measure: Visual Analog Pain Scale (VAS)
time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
description: VAS is a measurement score that indicates pain severity status. VAS score comprised a 10-cm line with ''none'' (0) on one end of the scale and ''disabling pain'' (10) on the other.
measure: Oswestry Disability Index (ODI)
time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
description: The ODI is based on a self-administered questionnaire measuring ''back-specific function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale.20 The ODI scores ranges from 0 to 100, with higher scores indicating severe symptoms.
measure: EQ-5D
time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
description: EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.
measure: PainDETECT
time frame: 3, 6, and 12, months, and every year, up to 5 year after operation
description: The painDETECT Questionnaire (PDQ) is a screening tool designed to detect neuropathic pain in patients with chronic low back pain (LBP) based on self-reported pain characteristics. The degree of the seven types of pain quality, the type of pain pattern, and the presence of radiating pain. From the three components of the PDQ, a total score is calculated; a high score indicates that the pain is likely to have a neuropathic component. Scoring is performed using a scoring manual, and results in a final screening score: a score of 0-12 indicates nociceptive pain, 19-38 indicates neuropathic pain, and 13-18 indicates mixed pain.
measure: Fusion rates
time frame: every year, up to 5 year after operation
description: This is assessed by postoperative simple radiography at 1 year after surgery
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: every year, up to 5 year after operation
description: Device related adverse events (fracture, translation, subsidence, osteolysis), Surgery related adverse events (incidental durotomy, wound infection, re-operation, re-admission)
measure: Operation duration
time frame: Immediate after operation
description: Intraoperative time
measure: Intraoperative blood loss
time frame: Immediate after operation
description: Intraoperative blood loss
measure: Postoperative drainage
time frame: Within 3 days after operation
description: Total drainage after surgery
measure: Amount of transfusion
time frame: Within 7 days after operation
description: Total transfusion during and after surgery
arm group label: Novomax
arm group type: Experimental
description: Novomax(R) ceramic glass spacer for interbody fusion
arm group label: PEEK cage
arm group type: Active Comparator
description: PEEK cage for interbody fusion
intervention type: Device
intervention name: NovoMax, BioAlpha Inc, Seong-nam, Korea
description: CaO-SiO2-P2O5-B2O3 glass ceramics spacer
arm group label: Novomax
intervention type: Device
intervention name: PEEK cage
description: PEEK cage
arm group label: PEEK cage
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin S. Yeom
investigator title: Professor
mesh term: Spinal Stenosis