xml: <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/NCT05993195</url>
    </required_header>
    <id_info>
      <org_study_id>20213046</org_study_id>
      <nct_id>NCT05993195</nct_id>
    </id_info>
    <brief_title>Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion</brief_title>
    <official_title>Comparative Analysis of Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lahey Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>DePuy Synthes</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Lahey Clinic</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The purpose of this early study is to compare the clinical results of the new Conduit&#xD;
        Interbody device to the traditional Concorde Bullet Device. The primary objective is to&#xD;
        explore the rates and reasons for re-operation between both constructs at 2 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The demand for lumbar fusion continues to rise with the growing and aging population.&#xD;
        Additionally, new and innovative technologies continue to bring new devices to the market.&#xD;
        However, our understanding of how emerging constructs compare with existing technology is&#xD;
        lacking. The purpose of this study is to compare the clinical results of the new Conduit&#xD;
        Interbody device to the traditional Concorde Bullet Device in lumbar fusion, one or two&#xD;
        levels between L2-S1 will be included. Both transforaminal lumbar interbody fusion (TLIF) and&#xD;
        posterior lumbar interbody fusion (PLIF) approaches will be included in the patient cohort.&#xD;
        The primary objective is to explore the rates and reasons for re-operation between both&#xD;
        constructs at 2 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 12, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Reoperation rate</measure>
      <time_frame>1 year and at 2 years</time_frame>
      <description>a comparison of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumbar fusion in terms of reoperation rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Surgical Variables of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion</measure>
      <time_frame>2 years</time_frame>
      <description>Assessment of surgical variables, such as type of bone graft or bone graft extenders (including ViviGen, bone morphogenetic protein (BMP), tricalcium phosphate, local autograft, allograft, allograft chips, or demineralized bone matrix), on reoperations</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Baseline Demographics of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion</measure>
      <time_frame>1 year and 2 years</time_frame>
      <description>Demographics, comorbidities, will be assessed including efficacy, safety, and fusion rates.&#xD;
  Demographics include the following: gender, age, race, BMI, weight (oz.), height (inches), ASA class, surgery level.&#xD;
  Comorbidities include the following: diabetes, heart failure, coronary artery disease, anxiety/depression, active smoker, pre-operative opioid use.</description>
    </other_outcome>
    <other_outcome>
      <measure>EQ5D of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion</measure>
      <time_frame>1 year and 2 years</time_frame>
      <description>The EQ5D index scale is a 5-dimension standardized measurement of heath status developed by EuroQol. The EQ5D index is derived by applying a formula that consist of weights. It is calculated by assigning a numerical value to each response level (ie. 1 for &quot;no problem&quot;, 3 for &quot;extreme problem&quot;/&quot;unable to&quot;). The EQ5D scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health scale).</description>
    </other_outcome>
    <other_outcome>
      <measure>ODI of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion</measure>
      <time_frame>1 year and 2 years</time_frame>
      <description>The Oswestry Disability Index is a gold standard outcome measure that was designed to assess daily function for those who experience back pain. The questionnaire consists of 10 questions presented as a 6-Likert scale. For each section the total possible score is 5; the first statement marked would score=0; the last statement marked would score=5. Scores range from 0% to 100%.</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">100</enrollment>
    <condition>Degenerative Spondylolisthesis</condition>
    <condition>Lumbar Spondylosis</condition>
    <condition>Lumbar Spondylolisthesis</condition>
    <arm_group>
      <arm_group_label>Conduit Interbody device</arm_group_label>
      <description>The Conduit Titanium Interbody Graft will be compared to the Concorde Bullet Device group for PLIF and TLIF.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Concorde Bullet Device</arm_group_label>
      <description>The control group is patients with degenerative spondylotic disease undergoing either one level or two level fusions with Concorde Bullet Device interbody device.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Conduit Titanium Interbody Graft</intervention_name>
      <description>The Concorde Bullet Device is compared with Conduit Titanium Interbody Graft for lumber fusion in terms of reoperation rates at 2 years.</description>
      <arm_group_label>Conduit Interbody device</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Concorde Bullet Device</intervention_name>
      <description>This traditional device is to compare the clinical results of the new Conduit Titanium Interbody device for lumbar fusion</description>
      <arm_group_label>Concorde Bullet Device</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Inclusion of interbody devices resulted in higher of lumbar fusion, however, new devices&#xD;
          have not been fully evaluated clinical and radiographically in terms of overall outcomes.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 18 or older with symptomatic degenerative lumbar spondylotic disease,&#xD;
               either spondylosis, and/or spondylolisthesis&#xD;
  &#xD;
            -  who have failed conservative management of at least 6 weeks requiring 1 or 2 level&#xD;
               lumbar interbody fusion (either PLIF or TLIF)&#xD;
  &#xD;
            -  All patients included will be index surgeries (no re-operations).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who improve with consecutive management and do not undergo lumbar fusion&#xD;
               surgery&#xD;
  &#xD;
            -  Surgery performed in the thoracic or cervical spine&#xD;
  &#xD;
            -  Surgery performed for tumor, infection, or trauma Patients who have an unstable&#xD;
               fracture, tumor, and osteoporosis with T score exceeding -2.0&#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>Robert G Whitmore, MD, FAANS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lahey Hospital &amp; Medical Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Edilin Lopez, MD</last_name>
      <role>Study Director</role>
      <affiliation>Lahey Hospital &amp; Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Lahey Hospital and Medical Center</name>
        <address>
          <city>Burlington</city>
          <state>Massachusetts</state>
          <zip>01805</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Greiner-Perth R, Boehm H, Allam Y, Elsaghir H, Franke J. Reoperation rate after instrumented posterior lumbar interbody fusion: a report on 1680 cases. Spine (Phila Pa 1976). 2004 Nov 15;29(22):2516-20. doi: 10.1097/01.brs.0000144833.63581.c1.</citation>
      <PMID>15543064</PMID>
    </reference>
    <reference>
      <citation>Irmola TM, Hakkinen A, Jarvenpaa S, Marttinen I, Vihtonen K, Neva M. Reoperation Rates Following Instrumented Lumbar Spine Fusion. Spine (Phila Pa 1976). 2018 Feb 15;43(4):295-301. doi: 10.1097/BRS.0000000000002291.</citation>
      <PMID>28614279</PMID>
    </reference>
    <reference>
      <citation>Choudhri TF, Mummaneni PV, Dhall SS, Eck JC, Groff MW, Ghogawala Z, Watters WC 3rd, Dailey AT, Resnick DK, Sharan A, Wang JC, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 4: radiographic assessment of fusion status. J Neurosurg Spine. 2014 Jul;21(1):23-30. doi: 10.3171/2014.4.SPINE14267.</citation>
      <PMID>24980581</PMID>
    </reference>
    <reference>
      <citation>Carreon LY, Djurasovic M, Glassman SD, Sailer P. Diagnostic accuracy and reliability of fine-cut CT scans with reconstructions to determine the status of an instrumented posterolateral fusion with surgical exploration as reference standard. Spine (Phila Pa 1976). 2007 Apr 15;32(8):892-5. doi: 10.1097/01.brs.0000259808.47104.dd.</citation>
      <PMID>17426635</PMID>
    </reference>
    <reference>
      <citation>Carreon LY, Glassman SD, Schwender JD, Subach BR, Gornet MF, Ohno S. Reliability and accuracy of fine-cut computed tomography scans to determine the status of anterior interbody fusions with metallic cages. Spine J. 2008 Nov-Dec;8(6):998-1002. doi: 10.1016/j.spinee.2007.12.004. Epub 2008 Feb 14.</citation>
      <PMID>18280214</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>lumbar fusion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spondylolisthesis</mesh_term>
      <mesh_term>Spondylosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be shared with DePuy Synthes</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>2 years</ipd_time_frame>
      <ipd_access_criteria>The data is accessed only by the study sponsor.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993195
  org study id: 20213046
  nct id: NCT05993195
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The purpose of this early study is to compare the clinical results of the new Conduit
        Interbody device to the traditional Concorde Bullet Device. The primary objective is to
        explore the rates and reasons for re-operation between both constructs at 2 years.
  The demand for lumbar fusion continues to rise with the growing and aging population.
        Additionally, new and innovative technologies continue to bring new devices to the market.
        However, our understanding of how emerging constructs compare with existing technology is
        lacking. The purpose of this study is to compare the clinical results of the new Conduit
        Interbody device to the traditional Concorde Bullet Device in lumbar fusion, one or two
        levels between L2-S1 will be included. Both transforaminal lumbar interbody fusion (TLIF) and
        posterior lumbar interbody fusion (PLIF) approaches will be included in the patient cohort.
        The primary objective is to explore the rates and reasons for re-operation between both
        constructs at 2 years.
  observational model: Cohort
  time perspective: Retrospective
  measure: Reoperation rate
  time frame: 1 year and at 2 years
  description: a comparison of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumbar fusion in terms of reoperation rate
  measure: Surgical Variables of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion
  time frame: 2 years
  description: Assessment of surgical variables, such as type of bone graft or bone graft extenders (including ViviGen, bone morphogenetic protein (BMP), tricalcium phosphate, local autograft, allograft, allograft chips, or demineralized bone matrix), on reoperations
  measure: Baseline Demographics of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion
  time frame: 1 year and 2 years
  description: Demographics, comorbidities, will be assessed including efficacy, safety, and fusion rates.
  Demographics include the following: gender, age, race, BMI, weight (oz.), height (inches), ASA class, surgery level.
  Comorbidities include the following: diabetes, heart failure, coronary artery disease, anxiety/depression, active smoker, pre-operative opioid use.
  measure: EQ5D of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion
  time frame: 1 year and 2 years
  description: The EQ5D index scale is a 5-dimension standardized measurement of heath status developed by EuroQol. The EQ5D index is derived by applying a formula that consist of weights. It is calculated by assigning a numerical value to each response level (ie. 1 for "no problem", 3 for "extreme problem"/"unable to"). The EQ5D scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health scale).
  measure: ODI of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion
  time frame: 1 year and 2 years
  description: The Oswestry Disability Index is a gold standard outcome measure that was designed to assess daily function for those who experience back pain. The questionnaire consists of 10 questions presented as a 6-Likert scale. For each section the total possible score is 5; the first statement marked would score=0; the last statement marked would score=5. Scores range from 0% to 100%.
  arm group label: Conduit Interbody device
  description: The Conduit Titanium Interbody Graft will be compared to the Concorde Bullet Device group for PLIF and TLIF.
  arm group label: Concorde Bullet Device
  description: The control group is patients with degenerative spondylotic disease undergoing either one level or two level fusions with Concorde Bullet Device interbody device.
  intervention type: Device
  intervention name: Conduit Titanium Interbody Graft
  description: The Concorde Bullet Device is compared with Conduit Titanium Interbody Graft for lumber fusion in terms of reoperation rates at 2 years.
  arm group label: Conduit Interbody device
  intervention type: Device
  intervention name: Concorde Bullet Device
  description: This traditional device is to compare the clinical results of the new Conduit Titanium Interbody device for lumbar fusion
  arm group label: Concorde Bullet Device
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Robert G Whitmore, MD, FAANS
  role: Principal Investigator
  affiliation: Lahey Hospital & Medical Center
  last name: Edilin Lopez, MD
  role: Study Director
  affiliation: Lahey Hospital & Medical Center
  facility: 
  country: United States
  citation: Greiner-Perth R, Boehm H, Allam Y, Elsaghir H, Franke J. Reoperation rate after instrumented posterior lumbar interbody fusion: a report on 1680 cases. Spine (Phila Pa 1976). 2004 Nov 15;29(22):2516-20. doi: 10.1097/01.brs.0000144833.63581.c1.
  PMID: 15543064
  citation: Irmola TM, Hakkinen A, Jarvenpaa S, Marttinen I, Vihtonen K, Neva M. Reoperation Rates Following Instrumented Lumbar Spine Fusion. Spine (Phila Pa 1976). 2018 Feb 15;43(4):295-301. doi: 10.1097/BRS.0000000000002291.
  PMID: 28614279
  citation: Choudhri TF, Mummaneni PV, Dhall SS, Eck JC, Groff MW, Ghogawala Z, Watters WC 3rd, Dailey AT, Resnick DK, Sharan A, Wang JC, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 4: radiographic assessment of fusion status. J Neurosurg Spine. 2014 Jul;21(1):23-30. doi: 10.3171/2014.4.SPINE14267.
  PMID: 24980581
  citation: Carreon LY, Djurasovic M, Glassman SD, Sailer P. Diagnostic accuracy and reliability of fine-cut CT scans with reconstructions to determine the status of an instrumented posterolateral fusion with surgical exploration as reference standard. Spine (Phila Pa 1976). 2007 Apr 15;32(8):892-5. doi: 10.1097/01.brs.0000259808.47104.dd.
  PMID: 17426635
  citation: Carreon LY, Glassman SD, Schwender JD, Subach BR, Gornet MF, Ohno S. Reliability and accuracy of fine-cut computed tomography scans to determine the status of anterior interbody fusions with metallic cages. Spine J. 2008 Nov-Dec;8(6):998-1002. doi: 10.1016/j.spinee.2007.12.004. Epub 2008 Feb 14.
  PMID: 18280214
  responsible party type: Sponsor
  mesh term: Spondylolisthesis
  mesh term: Spondylosis
  sharing ipd: Yes
  ipd description: Data will be shared with DePuy Synthes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: 2 years
  ipd access criteria: The data is accessed only by the study sponsor.