<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/NCT03012776</url>
  </required_header>
  <id_info>
    <org_study_id>CL-2830 - US IDE</org_study_id>
    <nct_id>NCT03012776</nct_id>
  </id_info>
  <brief_title>A Pivotal Study of the Premia Spine TOPS™ System</brief_title>
  <official_title>A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Premia Spine</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Premia Spine</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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System)&#xD;
      is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a&#xD;
      single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1)&#xD;
      at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or&#xD;
      retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint&#xD;
      capsule.&#xD;
&#xD;
      Success will be assessed by means of a composite endpoint that measures improvement in in&#xD;
      patient reported outcomes and the absence of any major device related complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Degenerative spine disease is a normal part of the aging process and can cause pain and&#xD;
      significantly limit normal movement. The most commonly diagnosed condition is Lumbar Spinal&#xD;
      Stenosis (LSS) which presents with pain, and often weakness or numbness in the buttocks&#xD;
      and/or lower extremities that is worsened with standing and walking. For patients that do not&#xD;
      respond to conservative treatment decompressive surgery is indicated. When LSS is accompanied&#xD;
      by a diagnosis of degenerative spondylolisthesis, fusion of the affected segment is often&#xD;
      added to prevent progression of the instability that may accompany the removal of bony&#xD;
      elements as part of the decompression. While decompression and fusion have been shown to&#xD;
      significantly improve patient outcomes, when compared to decompression alone, fusion has been&#xD;
      associated with several comorbidities such as adjacent level degeneration and&#xD;
      pseudoarthrosis.&#xD;
&#xD;
      The TOPS System was designed as an alternative to fusion and is a motion preserving posterior&#xD;
      spine implant designed to provide dynamic stabilization to a single lumbar spine segment&#xD;
      following decompression surgery.&#xD;
&#xD;
      Patients meeting all of the entry criteria will be randomized (2:1) to receive either the&#xD;
      TOPS System or TLIF following decompression surgery. Patients will be followed for 5 years&#xD;
      and the composite primary endpoint will be assessed at 2 years following index surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Anticipated">June 2027</completion_date>
  <primary_completion_date type="Actual">June 27, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Oswestry Disability Index (ODI)</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>No subsequent surgical intervention</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic confirmation of fusion in control arm and non-fusion in the TOPS arm</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absence of any major device related adverse event</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Greater range-of-motion through flexion-extension</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in physical component score on SF-12</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">305</enrollment>
  <condition>Lumbar Spinal Stenosis</condition>
  <condition>Degenerative Spondylolisthesis</condition>
  <arm_group>
    <arm_group_label>TOPS System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Investigational surgical treatment using TOPS System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transforaminal Lumbar Interbody Fusion (TLIF)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control surgical treatment using interbody fusion and placement of posterolateral instrumentation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Total Posterior Spine System (TOPS)</intervention_name>
    <description>Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis</description>
    <arm_group_label>TOPS System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transforaminal Lumbar Interbody Fusion (TLIF)</intervention_name>
    <description>Fusion with placement of interbody cage and posterolateral instrumentation</description>
    <arm_group_label>Transforaminal Lumbar Interbody Fusion (TLIF)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be between 35 and 80 years of age;&#xD;
&#xD;
          -  Must demonstrate at a single level to be treated (L2/3, L3/4 or L4/5) all three of the&#xD;
             following;&#xD;
&#xD;
               1. Degenerative spondylolisthesis or retrolisthesis up to Grade I, as determined by&#xD;
                  the investigator based on flexion/extension X-rays,&#xD;
&#xD;
               2. At least moderate lumbar spinal stenosis, defined as at least a 25% reduction in&#xD;
                  either the central canal, the lateral recess space, and/or the foramen when&#xD;
                  compared to an adjacent level, as determined by the investigator based on MRI,&#xD;
&#xD;
               3. Thickening of the ligamentum flavum and/or scarring of the facet joint capsule as&#xD;
                  identified by the investigator based on MRI.&#xD;
&#xD;
          -  Have had at least six (6) months of failed conservative treatment prior to surgery&#xD;
             (e.g., physical therapy, use of anti-inflammatory medications at maximum recommended&#xD;
             dosage; administration of epidural/facet injections and/or nerve block);&#xD;
&#xD;
          -  Have an Oswestry Disability Index (ODI) score of at least 40/100 at baseline;&#xD;
&#xD;
          -  Have leg pain with a VAS score of at least 40/100 for at least one leg at baseline ;&#xD;
&#xD;
          -  Lower back pain with a VAS score of at least 10 points less than Worst Leg VAS score;&#xD;
&#xD;
          -  Neurogenic claudication (as defined by worsening leg pain when walking or standing,&#xD;
             which is reduced when sitting or bending forward);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of free fragment disc herniation at the index level or either adjacent level;&#xD;
&#xD;
          -  Less than 4mm of disc height at the index level;&#xD;
&#xD;
          -  Spondylolisthesis greater than Grade I;&#xD;
&#xD;
          -  Back or non-radicular leg pain of unknown etiology;&#xD;
&#xD;
          -  Stenosis caused by an extruded spinal disc fragment (e.g., herniation) or where the&#xD;
             etiology is considered to be congenital, iatrogenic, post-traumatic, or metabolic;&#xD;
&#xD;
          -  Known allergy or sensitivity to PEEK, titanium, cobalt chrome, and/or polyurethane;&#xD;
&#xD;
          -  Prior surgery at any lumbar vertebral level with instrumentation;&#xD;
&#xD;
          -  Prior surgery at the index or adjacent lumbar vertebral level;&#xD;
&#xD;
          -  Clinically compromised vertebral bodies at the affected level;&#xD;
&#xD;
          -  Scoliosis greater than ten (10) degrees by major Cobb angle;&#xD;
&#xD;
          -  BMI &gt; 40;&#xD;
&#xD;
          -  Osteoporosis;&#xD;
&#xD;
          -  Paget's disease, gout, osteomalacia, osteogenesis imperfecta, thyroid and/or&#xD;
             parathyroid gland disorder and/or other metabolic bone disease;&#xD;
&#xD;
          -  Active infection - systemic or local;&#xD;
&#xD;
          -  Active hepatitis;&#xD;
&#xD;
          -  AIDS, HIV, Rheumatoid arthritis or other autoimmune disease;&#xD;
&#xD;
          -  Tuberculosis - active or in the past 3 years;&#xD;
&#xD;
          -  Active malignancy;&#xD;
&#xD;
          -  Any medical condition requiring treatment with any drug known to potentially interfere&#xD;
             with bone/soft tissue healing or receiving radiation therapy that is expected to&#xD;
             continue for the duration of the study;&#xD;
&#xD;
          -  Cauda equina syndrome or neurogenic bowel/bladder dysfunction;&#xD;
&#xD;
          -  Vascular claudication due to severe arterial insufficiency of the legs;&#xD;
&#xD;
          -  Sustained pathologic lumbar fractures of the vertebra or multiple lumbar fractures of&#xD;
             the vertebra or hip;&#xD;
&#xD;
          -  Significant peripheral neuropathy causing decreased sensation in a stocking-like or&#xD;
             non-radicular and non-dermatomal distribution in the lower extremities;&#xD;
&#xD;
          -  Insulin-dependent diabetes mellitus;&#xD;
&#xD;
          -  Immunologically suppressed, receiving steroids &gt; 1 month out of the past year;&#xD;
&#xD;
          -  Current chemical/alcohol dependency;&#xD;
&#xD;
          -  Current smoker or user of tobacco products;&#xD;
&#xD;
          -  Pregnant or interested in becoming pregnant;&#xD;
&#xD;
          -  Currently involved in active spinal litigation;&#xD;
&#xD;
          -  Currently having a workman's compensation claim;&#xD;
&#xD;
          -  Currently incarcerated;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Adventist Health Glendale</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California - Irvine Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisenhower Desert Orthopedic Center</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <zip>92270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Medical Center, Spine Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boulder Neurosurgical &amp; Spine Associates</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sibley Hospital/Johns Hopkins</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Spine Institute</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Spine &amp; Brain Institute</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians Regional Medical Center</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kennedy White Orthopedic Center</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Health University Medical Center</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goodman Campbell Brain &amp; Spine</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Clinic</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Medical Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronson Neuroscience Center</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Neurosurgery &amp; Spine Associates, P.A.</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Oregon Orthopedics</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Institute of Pennsylvania</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPENN Health Systems Department of Neurosurgery</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Health Network</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Associates</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Back Institute</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurosurgical Associates, P.C.</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshall University</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wisconsin Bone and Joint S.C.</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</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>Spinal Stenosis</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03012776
org study id: CL-2830 - US IDE
nct id: NCT03012776
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System)
      is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a
      single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1)
      at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or
      retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint
      capsule.

      Success will be assessed by means of a composite endpoint that measures improvement in in
      patient reported outcomes and the absence of any major device related complications.
Degenerative spine disease is a normal part of the aging process and can cause pain and
      significantly limit normal movement. The most commonly diagnosed condition is Lumbar Spinal
      Stenosis (LSS) which presents with pain, and often weakness or numbness in the buttocks
      and/or lower extremities that is worsened with standing and walking. For patients that do not
      respond to conservative treatment decompressive surgery is indicated. When LSS is accompanied
      by a diagnosis of degenerative spondylolisthesis, fusion of the affected segment is often
      added to prevent progression of the instability that may accompany the removal of bony
      elements as part of the decompression. While decompression and fusion have been shown to
      significantly improve patient outcomes, when compared to decompression alone, fusion has been
      associated with several comorbidities such as adjacent level degeneration and
      pseudoarthrosis.

      The TOPS System was designed as an alternative to fusion and is a motion preserving posterior
      spine implant designed to provide dynamic stabilization to a single lumbar spine segment
      following decompression surgery.

      Patients meeting all of the entry criteria will be randomized (2:1) to receive either the
      TOPS System or TLIF following decompression surgery. Patients will be followed for 5 years
      and the composite primary endpoint will be assessed at 2 years following index surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in Oswestry Disability Index (ODI)
time frame: 24 months
measure: Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator
time frame: 24 months
measure: No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator
time frame: 24 months
measure: No subsequent surgical intervention
time frame: 24 months
measure: Radiographic confirmation of fusion in control arm and non-fusion in the TOPS arm
time frame: 24 months
measure: Absence of any major device related adverse event
time frame: 24 months
measure: Greater range-of-motion through flexion-extension
time frame: 24 months
measure: Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg
time frame: 24 months
measure: Reduction in physical component score on SF-12
time frame: 24 months
arm group label: TOPS System
arm group type: Experimental
description: Investigational surgical treatment using TOPS System
arm group label: Transforaminal Lumbar Interbody Fusion (TLIF)
arm group type: Active Comparator
description: Control surgical treatment using interbody fusion and placement of posterolateral instrumentation
intervention type: Device
intervention name: Total Posterior Spine System (TOPS)
description: Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis
arm group label: TOPS System
intervention type: Procedure
intervention name: Transforaminal Lumbar Interbody Fusion (TLIF)
description: Fusion with placement of interbody cage and posterolateral instrumentation
arm group label: Transforaminal Lumbar Interbody Fusion (TLIF)
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Spondylolisthesis
sharing ipd: Undecided