<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/NCT03751943</url>
  </required_header>
  <id_info>
    <org_study_id>CPR-00001</org_study_id>
    <nct_id>NCT03751943</nct_id>
  </id_info>
  <brief_title>NanoFUSE® PL Gutter PMCF</brief_title>
  <official_title>Clinical Investigation of NanoFUSE® Bioactive Matrix and Autogenous Bone in Posterolateral Spinal Fusion (Nonloadbearing)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NanoFUSE Biologics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NanoFUSE Biologics, LLC</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>
      This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE®&#xD;
      Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal&#xD;
      fusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are&#xD;
      not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and&#xD;
      pelvis.) These defects may be surgically created osseous defects created from traumatic&#xD;
      injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the&#xD;
      posterolateral spine. This product provides a bone graft substitute that remodels into the&#xD;
      recipient's skeletal system. Radiographic success will be the primary judgement of success.&#xD;
      All patient's achieving fused or probably fused status will be judged as a success.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiographic Success</measure>
    <time_frame>12 months</time_frame>
    <description>All patients achieving fused or probably fused status will be judged as successes at 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall patient success</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>Overall patient success will be based on all clinical and radiographic evaluation parameters and complications for the indication for use.&#xD;
Success criteria includes the following:&#xD;
Presence of radiographic fusion as evidenced by identification of new bone mass&#xD;
No hardware failure or screw blackout&#xD;
Decreased level of pain (VAS)&#xD;
Maintained or improved level of function (ODI)&#xD;
Maintained or improved neurological status</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <arm_group>
    <arm_group_label>NanoFuse® PL Gutter</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)</intervention_name>
    <description>NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter</description>
    <arm_group_label>NanoFuse® PL Gutter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grade I or II (less than 50% slip f the cephalic vertebra compared to the caudal&#xD;
             vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1&#xD;
             and L5&#xD;
&#xD;
          -  Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis&#xD;
             producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3&#xD;
             months of nonsurgical treatment, or such patients with worsening neurological&#xD;
             condition&#xD;
&#xD;
          -  Patients who are medically suitable for surgical management and the use of NanoFUSE®&#xD;
             Bioactive Matrix is consistent with product labeling&#xD;
&#xD;
          -  Patients who have consented for surgical treatment&#xD;
&#xD;
          -  Patients able to provide informed consent for the study and complete the&#xD;
             questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lytic spondylolisthesis&#xD;
&#xD;
          -  Non degenerative stenosis (example: tumor, trauma, epidural, lipomatosis)&#xD;
&#xD;
          -  Segmental kyphosis at the level of the spondylolisthesis&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  On long term disability or workers compensation claim&#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_contact>
    <last_name>Holly Cole</last_name>
    <phone>978-358-7307</phone>
    <phone_ext>1004</phone_ext>
    <email>hollycole@rqmis.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>John McGuire</last_name>
    <phone>978-358-7307</phone>
    <phone_ext>1003</phone_ext>
    <email>johnmcguire@rqmis.com</email>
  </overall_contact_backup>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Demineralized Bone Matrix</keyword>
  <keyword>Primary Lumbar Fusion</keyword>
  <keyword>Autograft Lumbar Fusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03751943
org study id: CPR-00001
nct id: NCT03751943
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE®
      Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal
      fusion.
NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are
      not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and
      pelvis.) These defects may be surgically created osseous defects created from traumatic
      injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the
      posterolateral spine. This product provides a bone graft substitute that remodels into the
      recipient's skeletal system. Radiographic success will be the primary judgement of success.
      All patient's achieving fused or probably fused status will be judged as a success.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Radiographic Success
time frame: 12 months
description: All patients achieving fused or probably fused status will be judged as successes at 12 months.
measure: Overall patient success
time frame: 12 months postoperatively
description: Overall patient success will be based on all clinical and radiographic evaluation parameters and complications for the indication for use.
Success criteria includes the following:
Presence of radiographic fusion as evidenced by identification of new bone mass
No hardware failure or screw blackout
Decreased level of pain (VAS)
Maintained or improved level of function (ODI)
Maintained or improved neurological status
arm group label: NanoFuse® PL Gutter
arm group type: Other
description: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) within one posterolateral gutter (unilateral)
intervention type: Device
intervention name: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)
description: NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter
arm group label: NanoFuse® PL Gutter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Holly Cole
phone: 978-358-7307
phone ext: 1004
email: hollycole@rqmis.com
last name: John McGuire
phone: 978-358-7307
phone ext: 1003
email: johnmcguire@rqmis.com
responsible party type: Sponsor
mesh term: Intervertebral Disc Degeneration
sharing ipd: Undecided