<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/NCT04408846</url>
  </required_header>
  <id_info>
    <org_study_id>NS02-01</org_study_id>
    <nct_id>NCT04408846</nct_id>
  </id_info>
  <brief_title>Minimally Invasive Surgery Versus Traditional Open Surgery In The Treatment Of Single Level Lumbar Stenosis</brief_title>
  <official_title>An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Surgery and Traditional Open Surgical Procedure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of minimally invasive surgical&#xD;
      technique over the traditional open surgical procedure in patients with degenerative lumbar&#xD;
      stenosis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The Study will be conducted in another research center. The Sponsor has changed.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Oswestry Disability Index (ODI)</measure>
    <time_frame>3 months</time_frame>
    <description>To observe the change of ODI as compared to baseline through follow-up terms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Oswestry Disability Index (ODI)</measure>
    <time_frame>Through 2 years</time_frame>
    <description>To observe the change of ODI as compared to baseline through follow-up terms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Numeric Pain Rating Score (NPRS)</measure>
    <time_frame>Through 2 years</time_frame>
    <description>To observe the change of NPRS as compared to baseline through follow-up terms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D)</measure>
    <time_frame>Through 2 years</time_frame>
    <description>To observe the change of EQ-5D as compared to baseline through follow-up terms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Douleur Neuropathique 4 (DN4)</measure>
    <time_frame>Through 2 years</time_frame>
    <description>To observe the change of DN4 as compared to baseline through follow-up terms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in The Health Transition Item from SF-36 (HTI Item)</measure>
    <time_frame>Through 2 years</time_frame>
    <description>To observe the change of HTI Item through follow-up terms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Clinical Global Impression Of Change (CGIC) scale</measure>
    <time_frame>Through 2 years</time_frame>
    <description>To observe the change of CGIC through follow-up terms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fusion rate success</measure>
    <time_frame>12 months and 24 months post op</time_frame>
    <description>Interbody fusion rate on CT based on Tan grades</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>14th day of hospital stay</time_frame>
    <description>Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Through 2 years</time_frame>
    <description>Document Adverse Events (incl. adverse events related to device) occurrence throughout the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Intervertebral Disc Degeneration</condition>
  <condition>Lumbar Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>Minimally invasive lumbar fusion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Open posterior lumbar fusion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lumbar fusion</intervention_name>
    <description>Patients will receive a single level instrumented fusion using a minimally invasive or open traditional surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon® Spinal System, is mandatory in this study and will be either minimally invasive or open.</description>
    <arm_group_label>Minimally invasive lumbar fusion</arm_group_label>
    <arm_group_label>Open posterior lumbar fusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 75 years;&#xD;
&#xD;
          -  Patient has single level degenerative lumbar spinal stenosis and an indication for a&#xD;
             single level instrumented lumbar fusion for the treatment;&#xD;
&#xD;
          -  Symptoms persisting for at least three months prior to surgery;&#xD;
&#xD;
          -  Given written Informed Consent;&#xD;
&#xD;
          -  Able and agree to fully comply with the clinical protocol and willing to adhere to&#xD;
             follow-up schedule and requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior lumbar spinal fusion at any level;&#xD;
&#xD;
          -  Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic,&#xD;
             inflammatory, neoplastic, structural or other pathology) that may have an impact on&#xD;
             subject safety, wellbeing or the intent and conduct of the study;&#xD;
&#xD;
          -  Any condition that cannot be treated with mini-invasive unilateral decompression and&#xD;
             fusion;&#xD;
&#xD;
          -  History or presence of any other major neurological disease or condition that may&#xD;
             interfere with the study assessments (e.g. significant peripheral neuropathy, multiply&#xD;
             sclerosis);&#xD;
&#xD;
          -  Previous enrollment in this study, current enrollment or plans to be enrolled in&#xD;
             another study (in parallel to this study).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630091</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</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 Stenosis</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT04408846
org study id: NS02-01
nct id: NCT04408846
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to determine the effectiveness of minimally invasive surgical
      technique over the traditional open surgical procedure in patients with degenerative lumbar
      stenosis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change from baseline in Oswestry Disability Index (ODI)
time frame: 3 months
description: To observe the change of ODI as compared to baseline through follow-up terms
measure: Change from baseline in Oswestry Disability Index (ODI)
time frame: Through 2 years
description: To observe the change of ODI as compared to baseline through follow-up terms
measure: Change from baseline in Numeric Pain Rating Score (NPRS)
time frame: Through 2 years
description: To observe the change of NPRS as compared to baseline through follow-up terms
measure: Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D)
time frame: Through 2 years
description: To observe the change of EQ-5D as compared to baseline through follow-up terms
measure: Change from baseline in Douleur Neuropathique 4 (DN4)
time frame: Through 2 years
description: To observe the change of DN4 as compared to baseline through follow-up terms
measure: Change from baseline in The Health Transition Item from SF-36 (HTI Item)
time frame: Through 2 years
description: To observe the change of HTI Item through follow-up terms
measure: Change from baseline in Clinical Global Impression Of Change (CGIC) scale
time frame: Through 2 years
description: To observe the change of CGIC through follow-up terms
measure: Fusion rate success
time frame: 12 months and 24 months post op
description: Interbody fusion rate on CT based on Tan grades
measure: Cost-effectiveness
time frame: 14th day of hospital stay
description: Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge.
measure: Adverse Events
time frame: Through 2 years
description: Document Adverse Events (incl. adverse events related to device) occurrence throughout the study
arm group label: Minimally invasive lumbar fusion
arm group type: Other
arm group label: Open posterior lumbar fusion
arm group type: Other
intervention type: Device
intervention name: Lumbar fusion
description: Patients will receive a single level instrumented fusion using a minimally invasive or open traditional surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon® Spinal System, is mandatory in this study and will be either minimally invasive or open.
arm group label: Minimally invasive lumbar fusion
arm group label: Open posterior lumbar fusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Intervertebral Disc Degeneration
mesh term: Constriction, Pathologic