<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/NCT01667770</url>
  </required_header>
  <id_info>
    <org_study_id>11BN113</org_study_id>
    <nct_id>NCT01667770</nct_id>
  </id_info>
  <brief_title>Dural Graft Equivalent Comparison Trial</brief_title>
  <acronym>DECOMPRESS</acronym>
  <official_title>Dural Graft Equivalent Comparison Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Hospital and Medical Center, Phoenix</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Joseph's Hospital and Medical Center, Phoenix</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is to find out which types of dural grafts used during surgery for Chiari&#xD;
      Malformations are superior. We believe that autologous dural grafts are superior to&#xD;
      non-autologous grafts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study compares autologous grafts vs. non-autologous grafts. Non-autologous grafts include&#xD;
      synthetics and grafts from animals. Autologous grafts have a better side-effect profile than&#xD;
      non-autologous grafts. We believe this improved side-effect profile will result in a&#xD;
      decreased incidence of reoperation for post-operative infections and post-operative fluid&#xD;
      collections (pseudomeningoceles and seromas). Study is open to all non-pregnant minor and&#xD;
      adult subjects. Subjects must have symptomatic Chiari Malformation described as &gt; or equal to&#xD;
      6mm descent of the cerebellar tonsils below the foramen magnum with accompanying headaches&#xD;
      and/or neurologic findings (arm pain/weakness, myelopathy, etc.). After the 12-month&#xD;
      follow-up is completed on the first 100 subjects there will be an interim analysis of the&#xD;
      results in order to determine whether one of the treatments has a statistically superior&#xD;
      outcome. If a statistically superior outcome is noted, the trial will stop after being&#xD;
      reviewed by a data monitoring committee. If no statistically significant difference is seen&#xD;
      at one year, the study will continue until the 12-month follow-up is completed on the 200th&#xD;
      patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2012</start_date>
  <completion_date type="Actual">March 12, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2016</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>Complications encountered during the subject's post-operative care</measure>
    <time_frame>2 years</time_frame>
    <description>After the 12-month follow-up is completed on the first 100 subjects there will be an interim analysis of the results in order to determine whether one of the treatments has a statistically superior outcome. If a statistically superior outcome is noted, the trial will stop after being reviewed by a data monitoring committee. If no statistically significant difference is seen at one year, the study will continue until the 12-month follow-up is completed on the 200th patient.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Chiari Malformation</condition>
  <arm_group>
    <arm_group_label>surgery - autologous graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using autologous graft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgery - non-autologous graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using using non-autologous graft</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>decompression of Chiari malformation</intervention_name>
    <description>Removal of a small section of bone at the back of the skull (posterior foramen magnum decompression) or upper cervical spine. During surgery, the covering of the brain (dura) is enlarged with a graft (autologous or non-autologous).</description>
    <arm_group_label>surgery - autologous graft</arm_group_label>
    <arm_group_label>surgery - non-autologous graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minor or adult males and females&#xD;
&#xD;
          -  Symptomatic Chiari Malformation&#xD;
&#xD;
          -  Greater or equal to 6mm descent of the cerebellar tonsils below the foramen magnum&#xD;
&#xD;
          -  Headaches and/or neurologic findings (e.g., arm pain/weakness, myelopathy, etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert F Spetzler, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barrow Neurosurgical Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph's Hospital and Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>June 11, 2021</last_update_submitted>
  <last_update_submitted_qc>June 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2021</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>Arnold-Chiari Malformation</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/NCT01667770
org study id: 11BN113
nct id: NCT01667770
lead sponsor: 
has dmc: No
This research study is to find out which types of dural grafts used during surgery for Chiari
      Malformations are superior. We believe that autologous dural grafts are superior to
      non-autologous grafts.
The study compares autologous grafts vs. non-autologous grafts. Non-autologous grafts include
      synthetics and grafts from animals. Autologous grafts have a better side-effect profile than
      non-autologous grafts. We believe this improved side-effect profile will result in a
      decreased incidence of reoperation for post-operative infections and post-operative fluid
      collections (pseudomeningoceles and seromas). Study is open to all non-pregnant minor and
      adult subjects. Subjects must have symptomatic Chiari Malformation described as > or equal to
      6mm descent of the cerebellar tonsils below the foramen magnum with accompanying headaches
      and/or neurologic findings (arm pain/weakness, myelopathy, etc.). After the 12-month
      follow-up is completed on the first 100 subjects there will be an interim analysis of the
      results in order to determine whether one of the treatments has a statistically superior
      outcome. If a statistically superior outcome is noted, the trial will stop after being
      reviewed by a data monitoring committee. If no statistically significant difference is seen
      at one year, the study will continue until the 12-month follow-up is completed on the 200th
      patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Complications encountered during the subject's post-operative care
time frame: 2 years
description: After the 12-month follow-up is completed on the first 100 subjects there will be an interim analysis of the results in order to determine whether one of the treatments has a statistically superior outcome. If a statistically superior outcome is noted, the trial will stop after being reviewed by a data monitoring committee. If no statistically significant difference is seen at one year, the study will continue until the 12-month follow-up is completed on the 200th patient.
arm group label: surgery - autologous graft
arm group type: Active Comparator
description: surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using autologous graft
arm group label: surgery - non-autologous graft
arm group type: Active Comparator
description: surgical intervention: decompression of Chiari malformation by suboccipital craniectomy using using non-autologous graft
intervention type: Procedure
intervention name: decompression of Chiari malformation
description: Removal of a small section of bone at the back of the skull (posterior foramen magnum decompression) or upper cervical spine. During surgery, the covering of the brain (dura) is enlarged with a graft (autologous or non-autologous).
arm group label: surgery - autologous graft
arm group label: surgery - non-autologous graft
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Robert F Spetzler, M.D.
role: Principal Investigator
affiliation: Barrow Neurosurgical Associates
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arnold-Chiari Malformation