<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/NCT04418830</url>
  </required_header>
  <id_info>
    <org_study_id>NUVA.LIB1119</org_study_id>
    <nct_id>NCT04418830</nct_id>
  </id_info>
  <brief_title>Lumbar Interbody Implant Study</brief_title>
  <official_title>A Prospective, Multicenter Study Evaluating the Safety and Performance of Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Thoracic and/or Lumbar Spine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NuVasive</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NuVasive</source>
  <oversight_info>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and performance of NuVasive interbody&#xD;
      implants when used during thoracic and/or lumbar spine surgery as measured by reported&#xD;
      complications, radiographic outcomes, and patient-reported outcomes. This study is being&#xD;
      undertaken to identify possible residual risks and to clarify mid- to long-term clinical&#xD;
      performance that may affect the benefit/risk ratios of these interbody implants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, uncontrolled, multicenter study to evaluate the safety and&#xD;
      performance of select interbody implant devices in patients who undergo interbody fusion&#xD;
      surgery. Consecutive patients at a given site who meet eligibility requirements will be asked&#xD;
      to consent to participate in the study. These patients will present with degenerative&#xD;
      conditions in the thoracic and/or lumbar spine that are amenable to surgical treatment and&#xD;
      will be screened prior to study enrollment. Once enrolled into the study, subjects will&#xD;
      undergo interbody fusion surgery using one of the NuVasive interbody implant groups based on&#xD;
      the surgeon's standard of care. At least 1050 subjects (a minimum of 75 patients in each&#xD;
      implant group) will be enrolled and will be followed for 24 months after the surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2024</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complications of Interbody Implants</measure>
    <time_frame>24 months</time_frame>
    <description>Rate of complications attributable to the use of the interbody implants to be studied</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic Fusion Success</measure>
    <time_frame>24 months</time_frame>
    <description>The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS).</measure>
    <time_frame>24 months</time_frame>
    <description>Back and leg pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (1.2 points and 1.6 points respectively) where 0 is &quot;No Pain&quot; and 10 is &quot;Unbearable Pain&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index.</measure>
    <time_frame>24 months</time_frame>
    <description>Disability measured by the Oswestry disability index (ODI) will be assessed to determine the percentage of subjects who meet MCID (12.8 points) where a higher score on the ODI indicates a more severe disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.</measure>
    <time_frame>24 months</time_frame>
    <description>Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications attributable to the use of any additional NuVasive instruments, implants, or technologies</measure>
    <time_frame>24 months</time_frame>
    <description>Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies</description>
  </secondary_outcome>
  <number_of_groups>14</number_of_groups>
  <enrollment type="Anticipated">1050</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <condition>Degenerative Spondylolisthesis</condition>
  <condition>Degenerative Scoliosis</condition>
  <condition>Spinal Stenosis</condition>
  <condition>Sagittal Deformity</condition>
  <arm_group>
    <arm_group_label>Base Interfixated System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Brigade Interfixated System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Coalesce Thoracolumbar Interbody</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohere XLIF Interbody System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>CoRoent Ti PLIF Interbody System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>CoRoent Ti TLIF Interbody System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>MLX - Medial Lateral Expandable Interbody System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Modulus TLIF Interbody System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Modulus XLIF Interbody System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>TLX Interbody System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>XLX ACR Interbody System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>CoRoent Ti XLIF Interbody System</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohere TLIF</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Modulus ALIF</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The Enrolled Population will include all subjects who meet the criteria for enrollment,&#xD;
        specifically, those subjects who:&#xD;
&#xD;
          -  Satisfied the inclusion and exclusion criteria&#xD;
&#xD;
          -  Signed the informed consent&#xD;
&#xD;
          -  Underwent the surgical procedure, as defined in this protocol&#xD;
&#xD;
        Subjects not meeting any of these criteria will not be considered enrolled in the study,&#xD;
        and therefore not included in any study population or analysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who are ≥18 years of age at the time of consent&#xD;
&#xD;
          2. Planned spine surgery using interbody implants at:&#xD;
&#xD;
               1. One or two adjacent thoracic, lumbar, and/or lumbosacral levels for degenerative&#xD;
                  disc disease or degenerative spondylolisthesis, or&#xD;
&#xD;
               2. One or two adjacent thoracic, lumbar, and/or lumbosacral levels for spinal&#xD;
                  stenosis (not applicable for MLX, TLX, or XLX ACR), or&#xD;
&#xD;
               3. Any number of thoracic, lumbar, and/or lumbosacral levels for degenerative&#xD;
                  scoliosis (defined as &gt;10º coronal curve), or&#xD;
&#xD;
               4. Any number of thoracic, lumbar, and/or lumbosacral levels for sagittal deformity&#xD;
                  (not applicable for MLX, TLX, or XLX ACR).&#xD;
&#xD;
          3. Use of one of the following implants (NuVasive, Inc., San Diego, CA):&#xD;
&#xD;
               1. Base Interfixated&#xD;
&#xD;
               2. Brigade Interfixated&#xD;
&#xD;
               3. Coalesce Thoracolumbar&#xD;
&#xD;
               4. Cohere TLIF&#xD;
&#xD;
               5. Cohere XLIF&#xD;
&#xD;
               6. Coroent Ti PLIF&#xD;
&#xD;
               7. Coroent Ti TLIF&#xD;
&#xD;
               8. Coroent Ti XLIF&#xD;
&#xD;
               9. MLX&#xD;
&#xD;
              10. Modulus ALIF&#xD;
&#xD;
              11. Modulus TLIF&#xD;
&#xD;
              12. Modulus XLIF&#xD;
&#xD;
              13. TLX&#xD;
&#xD;
              14. XLX ACR&#xD;
&#xD;
          4. Interbody fusion with one or more of the following (as allowed by implant type):&#xD;
&#xD;
               1. autograft&#xD;
&#xD;
               2. allograft (i.e., cancellous and/or corticocancellous allograft bone)&#xD;
&#xD;
               3. Attrax Putty (NuVasive) (not applicable for MLX, TLX, or XLX ACR)&#xD;
&#xD;
          5. NuVasive supplemental internal fixation cleared by the applicable regulatory body for&#xD;
             use in the thoracolumbar spine (unless the interbody device to be used is interfixated&#xD;
             and is cleared by the regulatory body to be used standalone)&#xD;
&#xD;
          6. Able to undergo surgery based on physical exam, medical history, and surgeon judgment&#xD;
&#xD;
          7. Understands the conditions of enrollment, is willing to follow medical advice&#xD;
             including postoperative activity restrictions per the surgeon's standard of care, and&#xD;
             is willing to sign an informed consent form to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of any bone graft that is not cleared by the applicable regulatory body for use&#xD;
             within interbody implants. Examples of these include:&#xD;
&#xD;
               1. Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic))&#xD;
&#xD;
               2. Synthetic bone graft extenders (e.g., Attrax Scaffold (NuVasive), Formagraft&#xD;
                  (NuVasive), Mastergraft (Medtronic), Vitoss (Stryker), Actifuse (Baxter), nanOss&#xD;
                  (RTI Surgical), Fibergraft (Prosidyan/Depuy Synthes), ChronOs (Depuy Synthes))&#xD;
&#xD;
               3. Demineralized bone matrices (DBM) regulated as medical devices by the FDA (e.g.,&#xD;
                  Grafton Putty/Gel (Medtronic), DBX (MTF/Depuy Synthes), Accell Evo3 (IsoTis),&#xD;
                  Propel Putty/Gel (NuVasive))&#xD;
&#xD;
               4. Peptide enhanced bone graft (e.g., iFactor (Cerapedics))&#xD;
&#xD;
          2. Previous lumbar fusion surgery at the level(s) to be treated (adjacent level surgery&#xD;
             is acceptable; prior decompression is acceptable)&#xD;
&#xD;
          3. Patient is involved in active litigation relating to the spine (worker's compensation&#xD;
             claim is allowed if it is not contested)&#xD;
&#xD;
          4. Use of bone growth stimulators postoperatively&#xD;
&#xD;
          5. Active smoking within 6 weeks before surgery&#xD;
&#xD;
          6. Patient has known sensitivity to the materials implanted&#xD;
&#xD;
          7. Systemic or local infection (latent or active) or signs of local inflammation&#xD;
&#xD;
          8. Patient has inadequate bone stock or bone quality, or a physical or medical condition&#xD;
             that would prohibit beneficial surgical outcomes based on surgeon judgment&#xD;
&#xD;
          9. Patient is a prisoner&#xD;
&#xD;
         10. Patient is participating in another clinical study that would confound study data&#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>Kyle Malone, MS</last_name>
    <role>Study Director</role>
    <affiliation>NuVasive</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Verma Spine</name>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Spine Care</name>
      <address>
        <city>Merced</city>
        <state>California</state>
        <zip>95348</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hoag Orthopedics</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hartford Healthcare Bone and Joint Institute</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyerly Neurosurgery</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DuPage Medical Group</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital Research Institute</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Orthopaedics Group</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Brain and Spine</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summa Health</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Presbyterian</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spine Surgery</keyword>
  <keyword>Medical Device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04418830
org study id: NUVA.LIB1119
nct id: NCT04418830
lead sponsor: 
is us export: Yes
The objective of this study is to evaluate the safety and performance of NuVasive interbody
      implants when used during thoracic and/or lumbar spine surgery as measured by reported
      complications, radiographic outcomes, and patient-reported outcomes. This study is being
      undertaken to identify possible residual risks and to clarify mid- to long-term clinical
      performance that may affect the benefit/risk ratios of these interbody implants.
This study is a prospective, uncontrolled, multicenter study to evaluate the safety and
      performance of select interbody implant devices in patients who undergo interbody fusion
      surgery. Consecutive patients at a given site who meet eligibility requirements will be asked
      to consent to participate in the study. These patients will present with degenerative
      conditions in the thoracic and/or lumbar spine that are amenable to surgical treatment and
      will be screened prior to study enrollment. Once enrolled into the study, subjects will
      undergo interbody fusion surgery using one of the NuVasive interbody implant groups based on
      the surgeon's standard of care. At least 1050 subjects (a minimum of 75 patients in each
      implant group) will be enrolled and will be followed for 24 months after the surgery.
observational model: Cohort
time perspective: Prospective
measure: Complications of Interbody Implants
time frame: 24 months
description: Rate of complications attributable to the use of the interbody implants to be studied
measure: Radiographic Fusion Success
time frame: 24 months
description: The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS).
time frame: 24 months
description: Back and leg pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (1.2 points and 1.6 points respectively) where 0 is "No Pain" and 10 is "Unbearable Pain".
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index.
time frame: 24 months
description: Disability measured by the Oswestry disability index (ODI) will be assessed to determine the percentage of subjects who meet MCID (12.8 points) where a higher score on the ODI indicates a more severe disability.
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.
time frame: 24 months
description: Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
measure: Complications attributable to the use of any additional NuVasive instruments, implants, or technologies
time frame: 24 months
description: Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies
arm group label: Base Interfixated System
arm group label: Brigade Interfixated System
arm group label: Coalesce Thoracolumbar Interbody
arm group label: Cohere XLIF Interbody System
arm group label: CoRoent Ti PLIF Interbody System
arm group label: CoRoent Ti TLIF Interbody System
arm group label: MLX - Medial Lateral Expandable Interbody System
arm group label: Modulus TLIF Interbody System
arm group label: Modulus XLIF Interbody System
arm group label: TLX Interbody System
arm group label: XLX ACR Interbody System
arm group label: CoRoent Ti XLIF Interbody System
arm group label: Cohere TLIF
arm group label: Modulus ALIF
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kyle Malone, MS
role: Study Director
affiliation: NuVasive
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Scoliosis
mesh term: Spinal Stenosis
mesh term: Intervertebral Disc Degeneration
mesh term: Spondylolisthesis
sharing ipd: No