<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/NCT04418817</url>
  </required_header>
  <id_info>
    <org_study_id>NUVA.X1901</org_study_id>
    <nct_id>NCT04418817</nct_id>
  </id_info>
  <brief_title>Modulus in XLIF Study</brief_title>
  <official_title>An Assessment of the Safety and Performance of the Modulus® 3D-printed Titanium Interbody Implant in Patients Undergoing eXtreme Lateral Interbody Fusion (XLIF®)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NuVasive</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NuVasive</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the safety and performance of the Modulus&#xD;
      3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as&#xD;
      measured by reported complications, radiographic outcomes, and patient-reported outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients considered for this study will have previously undergone surgery for their spinal&#xD;
      condition according to the standard of care of the practitioner. All patients at a given site&#xD;
      who meet eligibility requirements will be asked to consent to participate in the study. Once&#xD;
      enrolled in the study, subjects will undergo a computed tomography (CT) scan at 12 months&#xD;
      postoperative or later to evaluate their fusion status. If the patient already had a&#xD;
      postoperative CT scan at 12 months or greater, this will be used in this study and an&#xD;
      additional CT scan should not be performed for this study. Available progress notes, medical&#xD;
      records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and&#xD;
      complications will be obtained from the medical records of all enrolled subjects.&#xD;
&#xD;
      The safety and performance of the Modulus XLIF interbody implant will be assessed using the&#xD;
      following:&#xD;
&#xD;
        1. Complications attributable to the use of the Modulus XLIF interbody implant as noted in&#xD;
           surgical summaries, progress notes, and hospital records&#xD;
&#xD;
        2. Radiographic outcome (fusion) and description of device status from plain film&#xD;
           radiographs and CT scan(s)&#xD;
&#xD;
        3. Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain&#xD;
           and disability), as available&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">March 22, 2020</start_date>
  <completion_date type="Anticipated">May 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 30, 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>Rate of Complications</measure>
    <time_frame>At least 12 months</time_frame>
    <description>Rate of complications attributable to use of the Modulus XLIF interbody implant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative</measure>
    <time_frame>At least 12 months</time_frame>
    <description>Proportion of subjects with fusion at 12 months or greater</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in neurologic status</measure>
    <time_frame>At least 12 months</time_frame>
    <description>Proportion of subjects with neurological improvement as compared to baseline</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <condition>Degenerative Spondylolisthesis</condition>
  <condition>Degenerative Scoliosis</condition>
  <arm_group>
    <arm_group_label>Modulus XLIF Interbody System</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients considered for this study will have previously undergone surgery for their spinal&#xD;
        condition according to the standard of care of the practitioner. All patients at a given&#xD;
        site who meet eligibility requirements will be asked to consent to participate in the&#xD;
        study. Once enrolled in the study, subjects will undergo a computed tomography (CT) scan at&#xD;
        12 months postoperative or later to evaluate their fusion status.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients who are ≥18 years of age at the time of surgery&#xD;
&#xD;
          2. Treated with XLIF procedure with the Modulus 3D-printed titanium interbody implant at:&#xD;
&#xD;
               1. One or two thoracic and/or lumbar levels for degenerative disc disease or&#xD;
                  degenerative spondylolisthesis, or&#xD;
&#xD;
               2. Any number of thoracic and/or lumbar levels for degenerative scoliosis (defined&#xD;
                  as &gt;10º coronal curve)&#xD;
&#xD;
          3. Interbody fusion with autograft and/or allograft&#xD;
&#xD;
          4. Any NuVasive supplemental fixation&#xD;
&#xD;
          5. Patient is able and to undergo a CT scan. If the patient already had a postoperative&#xD;
             CT scan at 12 months or greater, this will be used in this study and an additional CT&#xD;
             scan should not be performed for this study.&#xD;
&#xD;
          6. Patient understands the conditions of enrollment and is willing to sign an informed&#xD;
             consent form to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of any bone graft with the Modulus XLIF interbody implant that is not FDA-cleared&#xD;
             for use in the interbody space. 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 (NuVasive), Formagraft (NuVasive),&#xD;
                  Mastergraft (Medtronic), Vitoss (Stryker), Actifuse (Baxter), nanOss (RTI&#xD;
                  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 currently treated level(s) (adjacent-level&#xD;
             surgery is acceptable)&#xD;
&#xD;
          3. Patients with active infection at the surgical site at the time of surgery&#xD;
&#xD;
          4. Patient is involved in active litigation relating to the spine (worker's compensation&#xD;
             claim is allowed if it is not contested)&#xD;
&#xD;
          5. Patient is unwilling or unable to undergo a CT scan due to pregnancy or other medical&#xD;
             condition&#xD;
&#xD;
          6. Patient is a prisoner&#xD;
&#xD;
          7. 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>Erik C. Spayde, MD Inc.</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Spine &amp; Neurosurgery Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</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 17, 2023</last_update_submitted>
  <last_update_submitted_qc>April 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</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>Scoliosis</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04418817
org study id: NUVA.X1901
nct id: NCT04418817
lead sponsor: 
is fda regulated drug: No
is us export: No
The primary objective of this study is to evaluate the safety and performance of the Modulus
      3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as
      measured by reported complications, radiographic outcomes, and patient-reported outcomes.
Patients considered for this study will have previously undergone surgery for their spinal
      condition according to the standard of care of the practitioner. All patients at a given site
      who meet eligibility requirements will be asked to consent to participate in the study. Once
      enrolled in the study, subjects will undergo a computed tomography (CT) scan at 12 months
      postoperative or later to evaluate their fusion status. If the patient already had a
      postoperative CT scan at 12 months or greater, this will be used in this study and an
      additional CT scan should not be performed for this study. Available progress notes, medical
      records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and
      complications will be obtained from the medical records of all enrolled subjects.

      The safety and performance of the Modulus XLIF interbody implant will be assessed using the
      following:

        1. Complications attributable to the use of the Modulus XLIF interbody implant as noted in
           surgical summaries, progress notes, and hospital records

        2. Radiographic outcome (fusion) and description of device status from plain film
           radiographs and CT scan(s)

        3. Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain
           and disability), as available
observational model: Cohort
time perspective: Retrospective
measure: Rate of Complications
time frame: At least 12 months
description: Rate of complications attributable to use of the Modulus XLIF interbody implant
measure: Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative
time frame: At least 12 months
description: Proportion of subjects with fusion at 12 months or greater
measure: Improvement in neurologic status
time frame: At least 12 months
description: Proportion of subjects with neurological improvement as compared to baseline
arm group label: Modulus XLIF Interbody System
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: 
country: United States
responsible party type: Sponsor
mesh term: Scoliosis
mesh term: Intervertebral Disc Degeneration
mesh term: Spondylolisthesis