<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/NCT04420143</url>
  </required_header>
  <id_info>
    <org_study_id>NUVA.EXP0120</org_study_id>
    <nct_id>NCT04420143</nct_id>
  </id_info>
  <brief_title>MLX/XLX ACR Expandable Lumbar Interbody Implants</brief_title>
  <official_title>An Assessment of the Safety and Performance of the MLX® Medial Lateral and XLX ACR® Expandable Lumbar 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>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and performance of thoracic and/or&#xD;
      lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported&#xD;
      complications, radiographic outcomes, and clinical patient 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 the MLX and XLX ACR interbody&#xD;
      implants.&#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;
      with surgeries that meet eligibility requirements will be included in the study and available&#xD;
      progress notes, medical records, patient-reported outcomes (PROs), radiographs, and&#xD;
      complications will be obtained from the medical records.&#xD;
&#xD;
      The safety and performance of the MLX and XLX ACR interbody implants will be assessed using&#xD;
      the following:&#xD;
&#xD;
        1. Complications attributable to the use of the associated interbody implant as noted in&#xD;
           surgical summaries, progress notes, and hospital records&#xD;
&#xD;
        2. Neurologic status, symptoms, and subject self-reported clinical outcomes (e.g., pain and&#xD;
           disability), as available&#xD;
&#xD;
        3. Radiographic outcome (fusion) and description of device status from plain film&#xD;
           radiographs and computed tomography (CT) scan(s), as available&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2020</start_date>
  <completion_date type="Actual">October 23, 2020</completion_date>
  <primary_completion_date type="Actual">October 23, 2020</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 three months</time_frame>
    <description>Rate of complications (i.e., safety) attributable to use of the associated interbody implants (MLX or XLX ACR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Subjects with Improvement in Neurological Symptoms</measure>
    <time_frame>At least three months</time_frame>
    <description>The rate of improvement as compared to baseline in preoperative neurological symptoms will be measured using a standard motor/sensory neurological exam.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects with Apparent Radiographic Fusion</measure>
    <time_frame>12 months or greater</time_frame>
    <description>Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative, as imaging is available</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">109</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <condition>Spondylolisthesis</condition>
  <condition>Degenerative Scoliosis</condition>
  <arm_group>
    <arm_group_label>MLX - Medial Lateral Expandable Lumbar Interbody System</arm_group_label>
    <description>Patients who underwent lumbar interbody fusion with the MLX expandable interbody implant will be included in the MLX - Medial Lateral Expandable Lumbar Interbody System cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XLX ACR Interbody System</arm_group_label>
    <description>Patients who underwent lumbar interbody fusion with the XLX ACR expandable interbody implant will be included in the XLX ACR Interbody System cohort.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        At least 90 (75 MLX, 15 XLX ACR) subjects will be enrolled in this multicenter study by at&#xD;
        least four investigative sites. A site may have more than one surgeon investigator&#xD;
        contributing to the total site enrollment. As a retrospective study, enrollment goals will&#xD;
        be determined with the surgeon investigator during site selection by the Sponsor and will&#xD;
        be based on available case volume. The site will identify potential subjects who are more&#xD;
        than three months from the surgery postoperative time point during the study duration for&#xD;
        inclusion in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who were ≥18 years of age at the time of surgery&#xD;
&#xD;
          2. Underwent spine surgery using either MLX or XLX ACR interbody implant (NuVasive, Inc.,&#xD;
             San Diego, CA) at:&#xD;
&#xD;
               1. One or two adjacent thoracic and/or lumbar levels for degenerative disc disease&#xD;
                  or 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 (i.e., cancellous and/or&#xD;
             corticocancellous allograft bone)&#xD;
&#xD;
          4. NuVasive supplemental internal fixation cleared by the applicable regulatory body for&#xD;
             use in the thoracolumbar spine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of any bone graft with the associated interbody implant that is not FDA-cleared&#xD;
             for use within interbody implants.&#xD;
&#xD;
             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. Systemic or local infection (latent or active) or signs of local inflammation&#xD;
             documented at the time of surgery&#xD;
&#xD;
          4. Patient was involved in active litigation relating to the spine during the&#xD;
             surgical/postoperative period (worker's compensation claim is allowed if it is not&#xD;
             contested)&#xD;
&#xD;
          5. Inadequate bone stock or bone quality documented at the time of surgery&#xD;
&#xD;
          6. Known sensitivity to materials implanted documented at the time of surgery&#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>Orthopaedic Specialty Institute</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</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>Carolina NeuroSurgery &amp; Spine Associates</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoCarolina Research Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 20, 2021</last_update_submitted>
  <last_update_submitted_qc>August 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</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/NCT04420143
org study id: NUVA.EXP0120
nct id: NCT04420143
lead sponsor: 
The objective of this study is to evaluate the safety and performance of thoracic and/or
      lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported
      complications, radiographic outcomes, and clinical patient 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 the MLX and XLX ACR interbody
      implants.
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
      with surgeries that meet eligibility requirements will be included in the study and available
      progress notes, medical records, patient-reported outcomes (PROs), radiographs, and
      complications will be obtained from the medical records.

      The safety and performance of the MLX and XLX ACR interbody implants will be assessed using
      the following:

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

        2. Neurologic status, symptoms, and subject self-reported clinical outcomes (e.g., pain and
           disability), as available

        3. Radiographic outcome (fusion) and description of device status from plain film
           radiographs and computed tomography (CT) scan(s), as available
observational model: Cohort
time perspective: Retrospective
measure: Rate of Complications
time frame: At least three months
description: Rate of complications (i.e., safety) attributable to use of the associated interbody implants (MLX or XLX ACR)
measure: Proportion of Subjects with Improvement in Neurological Symptoms
time frame: At least three months
description: The rate of improvement as compared to baseline in preoperative neurological symptoms will be measured using a standard motor/sensory neurological exam.
measure: Proportion of Subjects with Apparent Radiographic Fusion
time frame: 12 months or greater
description: Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative, as imaging is available
arm group label: MLX - Medial Lateral Expandable Lumbar Interbody System
description: Patients who underwent lumbar interbody fusion with the MLX expandable interbody implant will be included in the MLX - Medial Lateral Expandable Lumbar Interbody System cohort.
arm group label: XLX ACR Interbody System
description: Patients who underwent lumbar interbody fusion with the XLX ACR expandable interbody implant will be included in the XLX ACR Interbody System cohort.
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: 
country: United States
responsible party type: Sponsor
mesh term: Scoliosis
mesh term: Intervertebral Disc Degeneration
mesh term: Spondylolisthesis