<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/NCT03041896</url>
  </required_header>
  <id_info>
    <org_study_id>CRDC2016</org_study_id>
    <nct_id>NCT03041896</nct_id>
  </id_info>
  <brief_title>Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion</brief_title>
  <official_title>Retrospective Evaluation of the Clinical and Radiographic Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paradigm Spine</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MCRA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Paradigm Spine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2&#xD;
      levels with the coflex® Interlaminar Technology or decompression with or without fusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The coflex® Interlaminar Technology - manufactured by Paradigm Spine - is intended for use as&#xD;
      a permanent implant between the lamina of 1 or 2 lumbar motion segments in the treatment of&#xD;
      moderate to severe lumbar spinal stenosis. The device is specifically designed to provide&#xD;
      stabilization without fusion in cases of stenosis with or without facet joint hypertrophy,&#xD;
      subarticular recess stenosis or foraminal stenosis. It is restricted for use to one or two&#xD;
      levels in the region of L1 - L5.&#xD;
&#xD;
      The height of the neuroforamen is maintained and the facet joints will be relieved. By this a&#xD;
      further destruction is prevented. Unlike conventional stabilization methods as for example&#xD;
      spinal fusion, the function of the segment will be maintained and adjacent structures will be&#xD;
      effectively protected.&#xD;
&#xD;
      Possible risks, which could occur after implantation of the coflex® Interlaminar Technology&#xD;
      are breakage of the implant, displacement of the implant, pain which is caused by the&#xD;
      implant, infections, bleedings and hematoma. The benefit of the study lies in the fact that&#xD;
      first-time retrospective data is raised for potential improvement regarding therapy of lumbar&#xD;
      back pain with the treatment of the lumbar spinal stenosis, which, in the future, can lead to&#xD;
      an improvement of the therapy.&#xD;
&#xD;
      In this study, Paradigm Spine will retrospectively collect clinical and radiographic data for&#xD;
      patients treated with the coflex® Interlaminar Technology during normal conditions of use.&#xD;
      This data will provide evidence to support publications and marketing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology</measure>
    <time_frame>Study Duration Up to 6 months for data collection</time_frame>
    <description>To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Incidence of Secondary Surgical Interventions Post Surgeries.</measure>
    <time_frame>Study Duration up to 6 months data</time_frame>
    <description>To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits.</measure>
    <time_frame>Study Duration Up to 6 months for data collection</time_frame>
    <description>To assess the impact of demographics and risk factors on clinical, radiologic, and patient reported outcomes, and to assess the operative details and safety outcomes associated with the use of the device.&#xD;
The clinical outcomes will be summarized; however, since the collection of these measures is not standard of care, this data will only be collected as available. In addition, data will be used to analyze the association between coflex® Interlaminar Technology use and outcomes with age, race, workers' compensation, smoking status, and gender.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">5050</enrollment>
  <condition>Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>Decompression</arm_group_label>
    <description>Standard of care decompression for spinal stenosis, 1 or 2 levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fusion</arm_group_label>
    <description>Standard pedical and rod fixation with standard decompression, 1 or 2 levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>coflex®</arm_group_label>
    <description>Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hybrid</arm_group_label>
    <description>coflex and fusion at adjacent levels</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>coflex® Interlaminar Technology</intervention_name>
    <description>Interlaminer Technology</description>
    <arm_group_label>Decompression</arm_group_label>
    <arm_group_label>Fusion</arm_group_label>
    <arm_group_label>Hybrid</arm_group_label>
    <arm_group_label>coflex®</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients must meet the criteria specified in the device labeling including radiographic&#xD;
        confirmation of at least moderate lumbar stenosis, which narrows the central spinal canal&#xD;
        at one or two contiguous levels from L1-L5 that require surgical decompression.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must meet the criteria specified in the device labeling including&#xD;
             radiographic confirmation of at least moderate lumbar stenosis, which narrows the&#xD;
             central spinal canal at one or two contiguous levels from L1-L5 that require surgical&#xD;
             decompression.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria's for this study.&#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_official>
    <last_name>Abigail Allen</last_name>
    <role>Study Director</role>
    <affiliation>MCRA</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>October 6, 2016</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <results_first_submitted>February 5, 2019</results_first_submitted>
  <results_first_submitted_qc>May 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 19, 2020</results_first_posted>
  <last_update_submitted>May 6, 2020</last_update_submitted>
  <last_update_submitted_qc>May 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>There are no benefits to the subject as this data is being collected to obtain additional clinical evidence to support publications and marketing.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 2, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03041896/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Decompression</title>
          <description>Standard of care decompression for spinal stenosis, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
        </group>
        <group group_id="P2">
          <title>Fusion</title>
          <description>Standard pedical and rod fixation with standard decompression, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
        </group>
        <group group_id="P3">
          <title>Coflex®</title>
          <description>Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
        </group>
        <group group_id="P4">
          <title>Hybrid</title>
          <description>coflex and fusion at adjacent levels</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1486"/>
                <participants group_id="P2" count="1009"/>
                <participants group_id="P3" count="2299"/>
                <participants group_id="P4" count="256"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1486"/>
                <participants group_id="P2" count="1009"/>
                <participants group_id="P3" count="2236"/>
                <participants group_id="P4" count="253"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="63"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Decompression</title>
          <description>Standard of care decompression for spinal stenosis, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
        </group>
        <group group_id="B2">
          <title>Fusion</title>
          <description>Standard pedical and rod fixation with standard decompression, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
        </group>
        <group group_id="B3">
          <title>Coflex®</title>
          <description>Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
        </group>
        <group group_id="B4">
          <title>Hybrid</title>
          <description>coflex and fusion at adjacent levels</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1486"/>
            <count group_id="B2" value="1009"/>
            <count group_id="B3" value="2299"/>
            <count group_id="B4" value="256"/>
            <count group_id="B5" value="5050"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.9" spread="15.46"/>
                    <measurement group_id="B2" value="65.4" spread="11.54"/>
                    <measurement group_id="B3" value="68.1" spread="9.96"/>
                    <measurement group_id="B4" value="65.8" spread="10.34"/>
                    <measurement group_id="B5" value="65.6" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="856"/>
                    <measurement group_id="B2" value="402"/>
                    <measurement group_id="B3" value="1257"/>
                    <measurement group_id="B4" value="137"/>
                    <measurement group_id="B5" value="2652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="629"/>
                    <measurement group_id="B2" value="607"/>
                    <measurement group_id="B3" value="1040"/>
                    <measurement group_id="B4" value="119"/>
                    <measurement group_id="B5" value="2395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="564"/>
                    <measurement group_id="B2" value="196"/>
                    <measurement group_id="B3" value="539"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="1324"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="829"/>
                    <measurement group_id="B2" value="792"/>
                    <measurement group_id="B3" value="1720"/>
                    <measurement group_id="B4" value="223"/>
                    <measurement group_id="B5" value="3564"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="211"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="789"/>
                    <measurement group_id="B2" value="251"/>
                    <measurement group_id="B3" value="1009"/>
                    <measurement group_id="B4" value="53"/>
                    <measurement group_id="B5" value="2102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Specified</title>
                  <measurement_list>
                    <measurement group_id="B1" value="607"/>
                    <measurement group_id="B2" value="717"/>
                    <measurement group_id="B3" value="1198"/>
                    <measurement group_id="B4" value="189"/>
                    <measurement group_id="B5" value="2711"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology</title>
        <description>To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.</description>
        <time_frame>Study Duration Up to 6 months for data collection</time_frame>
        <population>The following arms: coflex® and Decompression, were the only arms where this data was collected and compared for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Coflex®</title>
            <description>Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
          </group>
          <group group_id="O2">
            <title>Decompression</title>
            <description>Standard of care decompression for spinal stenosis, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology</title>
          <description>To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.</description>
          <population>The following arms: coflex® and Decompression, were the only arms where this data was collected and compared for this study.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2058"/>
                <count group_id="O2" value="1428"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201.26" spread="208.64"/>
                    <measurement group_id="O2" value="191.75" spread="247.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Incidence of Secondary Surgical Interventions Post Surgeries.</title>
        <description>To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression.</description>
        <time_frame>Study Duration up to 6 months data</time_frame>
        <population>The following arms: coflex® , Fusion, and Decompression, were the only arms where this data was collected and compared for this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Decompression</title>
            <description>Standard of care decompression for spinal stenosis, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
          </group>
          <group group_id="O2">
            <title>Coflex®</title>
            <description>Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
          </group>
          <group group_id="O3">
            <title>Fusion</title>
            <description>Standard pedical and rod fixation with standard decompression, 1 or 2 levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Incidence of Secondary Surgical Interventions Post Surgeries.</title>
          <description>To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression.</description>
          <population>The following arms: coflex® , Fusion, and Decompression, were the only arms where this data was collected and compared for this study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1428"/>
                <count group_id="O2" value="2058"/>
                <count group_id="O3" value="1009"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="125"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits.</title>
        <description>To assess the impact of demographics and risk factors on clinical, radiologic, and patient reported outcomes, and to assess the operative details and safety outcomes associated with the use of the device.&#xD;
The clinical outcomes will be summarized; however, since the collection of these measures is not standard of care, this data will only be collected as available. In addition, data will be used to analyze the association between coflex® Interlaminar Technology use and outcomes with age, race, workers' compensation, smoking status, and gender.</description>
        <time_frame>Study Duration Up to 6 months for data collection</time_frame>
        <population>The data (clinical, radiologic, and PROs) was not collected from the sites.</population>
        <group_list>
          <group group_id="O1">
            <title>Decompression</title>
            <description>Standard of care decompression for spinal stenosis, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
          </group>
          <group group_id="O2">
            <title>Fusion</title>
            <description>Standard pedical and rod fixation with standard decompression, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
          </group>
          <group group_id="O3">
            <title>Coflex®</title>
            <description>Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
          </group>
          <group group_id="O4">
            <title>Hybrid</title>
            <description>coflex and fusion at adjacent levels&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
          </group>
        </group_list>
        <measure>
          <title>The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits.</title>
          <description>To assess the impact of demographics and risk factors on clinical, radiologic, and patient reported outcomes, and to assess the operative details and safety outcomes associated with the use of the device.&#xD;
The clinical outcomes will be summarized; however, since the collection of these measures is not standard of care, this data will only be collected as available. In addition, data will be used to analyze the association between coflex® Interlaminar Technology use and outcomes with age, race, workers' compensation, smoking status, and gender.</description>
          <population>The data (clinical, radiologic, and PROs) was not collected from the sites.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Not applicable as safety data were not collected during the study.</time_frame>
      <desc>No formal analysis of adverse events was performed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Decompression</title>
          <description>Standard of care decompression for spinal stenosis, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
        </group>
        <group group_id="E2">
          <title>Fusion</title>
          <description>Standard pedical and rod fixation with standard decompression, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
        </group>
        <group group_id="E3">
          <title>Coflex®</title>
          <description>Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.&#xD;
coflex® Interlaminar Technology: Interlaminer Technology</description>
        </group>
        <group group_id="E4">
          <title>Hybrid</title>
          <description>coflex and fusion at adjacent levels</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Glenn Stiegman</name_or_title>
      <organization>MCRA</organization>
      <phone>2025525800</phone>
      <email>gstiegman@mcra.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03041896
org study id: CRDC2016
nct id: NCT03041896
lead sponsor: 
collaborator: 
has dmc: No
To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2
      levels with the coflex® Interlaminar Technology or decompression with or without fusion.
The coflex® Interlaminar Technology - manufactured by Paradigm Spine - is intended for use as
      a permanent implant between the lamina of 1 or 2 lumbar motion segments in the treatment of
      moderate to severe lumbar spinal stenosis. The device is specifically designed to provide
      stabilization without fusion in cases of stenosis with or without facet joint hypertrophy,
      subarticular recess stenosis or foraminal stenosis. It is restricted for use to one or two
      levels in the region of L1 - L5.

      The height of the neuroforamen is maintained and the facet joints will be relieved. By this a
      further destruction is prevented. Unlike conventional stabilization methods as for example
      spinal fusion, the function of the segment will be maintained and adjacent structures will be
      effectively protected.

      Possible risks, which could occur after implantation of the coflex® Interlaminar Technology
      are breakage of the implant, displacement of the implant, pain which is caused by the
      implant, infections, bleedings and hematoma. The benefit of the study lies in the fact that
      first-time retrospective data is raised for potential improvement regarding therapy of lumbar
      back pain with the treatment of the lumbar spinal stenosis, which, in the future, can lead to
      an improvement of the therapy.

      In this study, Paradigm Spine will retrospectively collect clinical and radiographic data for
      patients treated with the coflex® Interlaminar Technology during normal conditions of use.
      This data will provide evidence to support publications and marketing.
observational model: Cohort
time perspective: Retrospective
measure: Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology
time frame: Study Duration Up to 6 months for data collection
description: To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.
measure: Overall Incidence of Secondary Surgical Interventions Post Surgeries.
time frame: Study Duration up to 6 months data
description: To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression.
measure: The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits.
time frame: Study Duration Up to 6 months for data collection
description: To assess the impact of demographics and risk factors on clinical, radiologic, and patient reported outcomes, and to assess the operative details and safety outcomes associated with the use of the device.
The clinical outcomes will be summarized; however, since the collection of these measures is not standard of care, this data will only be collected as available. In addition, data will be used to analyze the association between coflex® Interlaminar Technology use and outcomes with age, race, workers' compensation, smoking status, and gender.
arm group label: Decompression
description: Standard of care decompression for spinal stenosis, 1 or 2 levels.
arm group label: Fusion
description: Standard pedical and rod fixation with standard decompression, 1 or 2 levels.
arm group label: coflex®
description: Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.
arm group label: Hybrid
description: coflex and fusion at adjacent levels
intervention type: Device
intervention name: coflex® Interlaminar Technology
description: Interlaminer Technology
arm group label: Decompression
arm group label: Fusion
arm group label: Hybrid
arm group label: coflex®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abigail Allen
role: Study Director
affiliation: MCRA
responsible party type: Sponsor
mesh term: Spinal Stenosis
sharing ipd: Yes
ipd description: There are no benefits to the subject as this data is being collected to obtain additional clinical evidence to support publications and marketing.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 