<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/NCT01727752</url>
  </required_header>
  <id_info>
    <org_study_id>NTR1307</org_study_id>
    <nct_id>NCT01727752</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis</brief_title>
  <acronym>FELIX</acronym>
  <official_title>A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paradigm Spine</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Paradigm Spine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous&#xD;
      Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication&#xD;
      caused by Lumbar Stenosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this investigation, it will be investigated whether the effectiveness of surgical&#xD;
      intervention with Coflex® is equivalent to surgical decompression after 12 months in people&#xD;
      with intermittent claudication. The main advantage of coflex® might be a faster recovery&#xD;
      after surgery, but after long term follow-up it is unknown if this treatment effect remains.&#xD;
      Therefore in addition, it will be investigated whether surgical intervention with coflex® is&#xD;
      more effective than surgical decompression on short-term follow-up (8 weeks to 6 months) and&#xD;
      whether surgical intervention with coflex® is more cost-effective after 12 months than&#xD;
      surgical decompression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2007</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Zurich Claudication Questionnaire (ZCQ)</measure>
    <time_frame>5 years</time_frame>
    <description>ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EuroQOL (EQ-5D)</measure>
    <time_frame>5 years</time_frame>
    <description>The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRDQ</measure>
    <time_frame>5 years</time_frame>
    <description>The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>5 years</time_frame>
    <description>The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>McGill Pain Questionnaire</measure>
    <time_frame>5 years</time_frame>
    <description>The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS Leg Pain</measure>
    <time_frame>5 years</time_frame>
    <description>Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-operations, revisions, and major complications</measure>
    <time_frame>5 years</time_frame>
    <description>Assessment of revisions, removals, re-operations, and major device-related complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Assessment</measure>
    <time_frame>12 months</time_frame>
    <description>Radiographic Assessment of coflex and control group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">386</enrollment>
  <condition>Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>Surgical decompression</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical decompression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>coflex Interlaminar Technology</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical decompression followed by implantation of coflex Interlaminar Technology.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Decompression</intervention_name>
    <arm_group_label>Surgical decompression</arm_group_label>
    <arm_group_label>coflex Interlaminar Technology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  is 40 to 85 years old at time of surgery&#xD;
&#xD;
          -  has INC, as noted by leg/buttock/groin pain with or without back pain.&#xD;
             Leg/buttock/groin pain needs to be strongly relieved when flexed such as when sitting&#xD;
             in a chair&#xD;
&#xD;
          -  has received at least three months of conservative care therapy which may have&#xD;
             included, but is not limited to, physical therapy, bracing, systemic and/or injected&#xD;
             medications&#xD;
&#xD;
          -  has a regular indication for surgical intervention of INC&#xD;
&#xD;
          -  has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one&#xD;
             or two levels confirmed by MRI&#xD;
&#xD;
          -  is physically and mentally willing and able to comply with, or has a caregiver who is&#xD;
             willing and able to comply with, the post-operative evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has cauda equina syndrome defined as neural compression causing neurogenic bowel&#xD;
             (rectal incontinence) or bladder dysfunction (bladder retention or incontinence)&#xD;
&#xD;
          -  has Paget's disease, severe osteoporosis or metastasis to the vertebrae&#xD;
&#xD;
          -  has significant scoliosis (Cobb angle &gt; 25 degrees)&#xD;
&#xD;
          -  has a Body Mass Index (BMI) &gt; 40 kg/m2&#xD;
&#xD;
          -  has had any surgery of the lumbar spine&#xD;
&#xD;
          -  has degenerative spondylolisthesis &gt; grade 1 (on a scale 1 to 4) at the affected level&#xD;
&#xD;
          -  has significant instability of the lumbar spine&#xD;
&#xD;
          -  has severe comorbid conditions that will increase the risk to the patient or interfere&#xD;
             with the evaluability of this study&#xD;
&#xD;
          -  has a fused segment at the indicated level.&#xD;
&#xD;
          -  has a herniated disk on the level of interest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sint Lucas Andreas Ziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reinier De Graaf Gasthuis</name>
      <address>
        <city>Delft</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groene Hart Ziekenhuis</name>
      <address>
        <city>Gouda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Alkmaar</name>
      <address>
        <city>Holland</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diaconessenhuis</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rijnland ziekenhuis,</name>
      <address>
        <city>Leiderdorp</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canisius-Wilhelmina Ziekenhuis</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vlietland Ziekenhuis</name>
      <address>
        <city>Schiedam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Haaglanden</name>
      <address>
        <city>The Hague/Leidschendam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronovo Ziekenhuis</name>
      <address>
        <city>The Hague</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HAGA ziekenhuis</name>
      <address>
        <city>The Hague</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala Klinieken</name>
      <address>
        <city>Zwolle</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>March 29, 2016</last_update_submitted>
  <last_update_submitted_qc>March 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2016</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>Intermittent Claudication</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/NCT01727752
org study id: NTR1307
nct id: NCT01727752
lead sponsor: 
has dmc: No
A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous
      Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication
      caused by Lumbar Stenosis
In this investigation, it will be investigated whether the effectiveness of surgical
      intervention with Coflex® is equivalent to surgical decompression after 12 months in people
      with intermittent claudication. The main advantage of coflex® might be a faster recovery
      after surgery, but after long term follow-up it is unknown if this treatment effect remains.
      Therefore in addition, it will be investigated whether surgical intervention with coflex® is
      more effective than surgical decompression on short-term follow-up (8 weeks to 6 months) and
      whether surgical intervention with coflex® is more cost-effective after 12 months than
      surgical decompression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Zurich Claudication Questionnaire (ZCQ)
time frame: 5 years
description: ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
measure: EuroQOL (EQ-5D)
time frame: 5 years
description: The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation.
measure: MRDQ
time frame: 5 years
description: The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain.
measure: SF-36
time frame: 5 years
description: The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients.
measure: McGill Pain Questionnaire
time frame: 5 years
description: The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain.
measure: VAS Leg Pain
time frame: 5 years
description: Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group
measure: Re-operations, revisions, and major complications
time frame: 5 years
description: Assessment of revisions, removals, re-operations, and major device-related complications.
measure: Radiographic Assessment
time frame: 12 months
description: Radiographic Assessment of coflex and control group
arm group label: Surgical decompression
arm group type: Active Comparator
description: Surgical decompression
arm group label: coflex Interlaminar Technology
arm group type: Active Comparator
description: Surgical decompression followed by implantation of coflex Interlaminar Technology.
intervention type: Procedure
intervention name: Decompression
arm group label: Surgical decompression
arm group label: coflex Interlaminar Technology
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Intermittent Claudication
mesh term: Constriction, Pathologic