<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/NCT01714804</url>
  </required_header>
  <id_info>
    <org_study_id>ACC3-US-2012-1</org_study_id>
    <nct_id>NCT01714804</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion</brief_title>
  <official_title>Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SeaSpine, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SeaSpine, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to prospectively evaluate the performance of Integra Accell&#xD;
      Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a&#xD;
      retrospective comparison to a historical patient cohort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to prospectively evaluate the performance of Integra Accell&#xD;
      Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion in&#xD;
      comparison to a retrospective cohort of Infuse subjects. Infuse subjects were not enrolled in&#xD;
      the current study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</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>Number of Levels With Posterolateral Fusion</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Stenosis</condition>
  <condition>Spondylosis</condition>
  <condition>Degenerative Changes</condition>
  <arm_group>
    <arm_group_label>Prospective</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Accell Evo3</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accell Evo3 Prospective Use</intervention_name>
    <arm_group_label>Prospective</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are 18 (eighteen) years of age or older at the time of surgery.&#xD;
&#xD;
          -  Require spinal fusion using TLIF, PLF or PLIF, with the use of an interbody spacer, at&#xD;
             1 to 3 levels between L3-S1.&#xD;
&#xD;
          -  Willing and able to return for the scheduled follow-up visits, follow post-operative&#xD;
             instructions and undergo the required radiographic exams (A/P, Lateral Neutral and&#xD;
             Lateral Flexion/Extension X-rays) for up to 3 time points between 6 months and 24&#xD;
             months post-surgery (6±2 months, 12±3 months and 24±4 months post-surgery), including&#xD;
             one CT-scan at 12±3 months.&#xD;
&#xD;
          -  Unresponsive to conservative care over a period of at least 6 months or has signs&#xD;
             and/or symptoms that mandate urgent surgical intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are long term users of medications (i.e. steroids greater than 2-weeks) that are known&#xD;
             to inhibit fusion or bone metabolism at any time within 6 months prior to surgery.&#xD;
             Exceptions are inhaled steroids for asthma treatment (i.e. patients on inhaled&#xD;
             steroids are allowed), or epidural steroid injections.&#xD;
&#xD;
          -  Are taking immunosuppressive agents (Cancer chemotherapy, treatment with Disease&#xD;
             Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs) or are&#xD;
             treated with Growth Factors or Insulin at any time within 6 months prior to surgery.&#xD;
&#xD;
          -  Are being treated with radiotherapy.&#xD;
&#xD;
          -  Are having medical conditions, known to impact bone metabolism, such as Paget's&#xD;
             disease, osteoporosis.&#xD;
&#xD;
          -  Are smokers and/or nicotine/tobacco users.&#xD;
&#xD;
          -  Are pregnant, lactating or women wishing to become pregnant.&#xD;
&#xD;
          -  Are a prisoner.&#xD;
&#xD;
          -  Are currently participating in an investigational drug or another device study that&#xD;
             has not completed the primary endpoint or that clinically interferes with the study&#xD;
             endpoints.&#xD;
&#xD;
          -  Prior spine surgery at the index level except posterior decompressive surgery where&#xD;
             the posterior elements are preserved e.g. facet saving techniques such as discectomy,&#xD;
             laminotomy, and intradiscal procedures.&#xD;
&#xD;
          -  Use of any other bone graft or bone graft substitute in addition to or in place of&#xD;
             Accell Evo3® with the exception of local autograft and/or cancellous bone chips.&#xD;
&#xD;
          -  Use of routine prophylactic NSAIDS for 3 months post-operatively, but low dose&#xD;
             concomitant pain medications e.g. aspirin should be continued and recorded on the&#xD;
             Concomitant Pain Medications case report form (CRF).&#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>Jim Youssef, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spine Colorado</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spine Colorado</name>
      <address>
        <city>Durango</city>
        <state>Colorado</state>
        <zip>81301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>November 20, 2017</results_first_submitted>
  <results_first_submitted_qc>November 20, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 20, 2017</results_first_posted>
  <last_update_submitted>December 21, 2017</last_update_submitted>
  <last_update_submitted_qc>December 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bone Morphogenetic Protein (BMP)</keyword>
  <keyword>Demineralized bone matrix (DBM)</keyword>
  <keyword>Fusion rates</keyword>
  <keyword>Interbody fusion</keyword>
  <keyword>Lumbar spine</keyword>
  <keyword>Transverse lumbar interbody fusion (TLIF)</keyword>
  <keyword>Patient reported outcomes</keyword>
  <keyword>Posterolateral lumbar fusion (PLF)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylosis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Accell Evo3</title>
          <description>Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.</description>
        </group>
        <group group_id="P2">
          <title>Infuse</title>
          <description>Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space. Subjects in this treatment arm were historical controls and were not enrolled in this study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prospective</title>
          <description>Accell Evo3&#xD;
Accell Evo3 prospective study arm</description>
        </group>
        <group group_id="B2">
          <title>Retrospective</title>
          <description>Infuse&#xD;
rh-BMP2 retrospective study arm</description>
        </group>
        <group group_id="B3">
          <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="29"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="59"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&gt;18 years old</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Levels With Posterolateral Fusion</title>
        <description>Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately</description>
        <time_frame>12 months</time_frame>
        <population>One level is defined as a spinal segment in the lumbar spine.</population>
        <group_list>
          <group group_id="O1">
            <title>Accell Evo3</title>
            <description>Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 to S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.</description>
          </group>
          <group group_id="O2">
            <title>Infuse</title>
            <description>Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 to S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Levels With Posterolateral Fusion</title>
          <description>Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately</description>
          <population>One level is defined as a spinal segment in the lumbar spine.</population>
          <units>levels</units>
          <param>Count of Units</param>
          <units_analyzed>levels</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>levels</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg)</title>
        <time_frame>12 months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Accell Evo3</title>
            <description>Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.</description>
          </group>
          <group group_id="O2">
            <title>Infuse</title>
            <description>Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space. Subjects in this treatment arm were historical controls and were not enrolled in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg)</title>
          <population>Data were not collected</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 24 months post surgery</time_frame>
      <desc>Adverse events: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research</desc>
      <group_list>
        <group group_id="E1">
          <title>Accell Evo3</title>
          <description>Prospectively enrolled patients who required posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Accell Evo3 was used with autogenous cancellous bone in the posterolateral space.</description>
        </group>
        <group group_id="E2">
          <title>Infuse</title>
          <description>Retrospective patients who were treated with posterolateral fusion at one to three levels between L3 and S1. Treatment included standard instrumented posterolateral fusion with interbody fusion by TLIF at the discretion of the surgeon. Infuse (rh-BMP2) was used with autogenous cancellous bone in the posterolateral space.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Blood Pressure increase</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract surgery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Adjacent segment disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>carpal tunnel trigger finger</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>CMC arthroplasty, thumb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>headache, rib and back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Upper extremity numbness; guyon's canal release</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Surgery for lipoma, right flank</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>epidural hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever and burning around incision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back and thigh pain (stinging)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Adjacent segment disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Neck and low back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Low back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Flare up of hip pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Numbness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Buttox pain</sub_title>
                <description>Buttocks pain; possibly neuritis secondary to BMP</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dysuria/stress incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </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 Investigator may not submit the results of the study for publication, without the sponsor's prior permission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vice President, Orthobiologics Research &amp; Development</name_or_title>
      <organization>SeaSpine</organization>
      <phone>760.216.5138</phone>
      <email>frank.vizesi@seaspine.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/NCT01714804
org study id: ACC3-US-2012-1
nct id: NCT01714804
lead sponsor: 
has dmc: No
The objective of this study is to prospectively evaluate the performance of Integra Accell
      Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a
      retrospective comparison to a historical patient cohort.
The objective of this study is to prospectively evaluate the performance of Integra Accell
      Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion in
      comparison to a retrospective cohort of Infuse subjects. Infuse subjects were not enrolled in
      the current study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Levels With Posterolateral Fusion
time frame: 12 months
description: Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately
measure: Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg)
time frame: 12 months
arm group label: Prospective
arm group type: Experimental
description: Accell Evo3
intervention type: Device
intervention name: Accell Evo3 Prospective Use
arm group label: Prospective
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jim Youssef, MD
role: Principal Investigator
affiliation: Spine Colorado
facility: 
country: United States
responsible party type: Sponsor
mesh term: Spondylosis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 