<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/NCT02234154</url>
  </required_header>
  <id_info>
    <org_study_id>1513-CL-TP-01 NOT UK</org_study_id>
    <nct_id>NCT02234154</nct_id>
  </id_info>
  <brief_title>Post-market Study of the TOPS™ System</brief_title>
  <official_title>A Study to Evaluate the Safety and Effectiveness of the 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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for&#xD;
      lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is being conducted to evaluate the TOPS™ SP System from (&quot;TOPS™ System&quot; or&#xD;
      &quot;TOPS&quot;). TOPS is an alternative to spinal fusion and is designed to stabilize but not fuse&#xD;
      the affected vertebral level to alleviate pain stemming from degenerative spondylolisthesis&#xD;
      (abnormal/excessive movement of the vertebrae causing pain in the lower back and legs) and&#xD;
      spinal stenosis (narrowing of the spinal canal resulting in compression of nerves producing&#xD;
      symptoms of pain, numbness and tingling in the legs).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in ODI and Improvement in VAS leg score v</measure>
    <time_frame>24 months post implantation</time_frame>
    <description>Composite endpoint - Subjects who exhibit a reduction of 15 percent in their Oswestry Disability Index (ODI) score compared to their preoperative ODI score AND a reduction of at least 20mm (20% improvement) in either of their VAS Leg Score will be considered a success.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in back and leg visual analog scales (VAS)</measure>
    <time_frame>24 month postoperatively</time_frame>
    <description>A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in ZCQ scores</measure>
    <time_frame>24 months postoperatively</time_frame>
    <description>A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-36)</measure>
    <time_frame>24 months postoperatively</time_frame>
    <description>A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maintenance or improvement in neurological symptoms</measure>
    <time_frame>24 months postoperatively</time_frame>
    <description>A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Lumbar Spinal Stenosis</condition>
  <condition>Spondylolisthesis</condition>
  <arm_group>
    <arm_group_label>TOPS System</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Post Marketing Study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TOPS System</intervention_name>
    <description>Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.</description>
    <arm_group_label>TOPS System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        IInclusion Criteria - Prospective subjects must meet all of the following criteria to be&#xD;
        considered eligible for inclusion in this clinic study:&#xD;
&#xD;
          -  Age 40-85 years old;&#xD;
&#xD;
          -  One or both of the following at a single level from L3 to L5; (1) symptomatic&#xD;
             monosegmental lumbar spinal stenosis or facet arthrosis, (2) degenerative&#xD;
             spondylolisthesis up to and including grade 1.&#xD;
&#xD;
          -  At least three (3) months of failed, conservative treatment prior to surgery (unless&#xD;
             deemed inadvisable due to progressive motor weakness or other evidence of rapidly&#xD;
             deteriorating condition) including the use of anti-inflammatory medications at maximum&#xD;
             specified dosage, administration of epidural/facet injections, rest, heat,&#xD;
             electrotherapy and/or physical therapy;&#xD;
&#xD;
          -  Narrowing of the lumbar spinal canal (central and/or foramenal) classified as moderate&#xD;
             to severe using CT scans/MRI;&#xD;
&#xD;
          -  VAS leg pain of at least 40/100;&#xD;
&#xD;
          -  Oswestry Disability Index score of at least 40/100;&#xD;
&#xD;
          -  Lower back pain or sciatica with or without spinal claudication and&#xD;
&#xD;
          -  Psychosocially, mentally and physically able to fully comply with the clinical&#xD;
             protocol and willing to adhere to follow-up schedule and requirements.&#xD;
&#xD;
        Exclusion Criteria - Prospective subjects must not meet any of the exclusion criteria to&#xD;
        participate in this clinical study:&#xD;
&#xD;
          -  Primary diagnosis of discogenic back pain at the TOPS System level;&#xD;
&#xD;
          -  Back or non-radicular leg pain of unknown etiology at the index level;&#xD;
&#xD;
          -  Lytic spondylolisthesis at the index level;&#xD;
&#xD;
          -  More than one (1) motion segment involved in the degenerative pathology to the extent&#xD;
             that justifies its inclusion in the surgical procedure, unless a decompression alone&#xD;
             can be done at that level without compromising stability;&#xD;
&#xD;
          -  Known allergy to titanium and/or polyurethane;&#xD;
&#xD;
          -  Supplemental interbody support required (e.g., bone graft, spacers, VBRs, or fusion&#xD;
             cages) at the index level;&#xD;
&#xD;
          -  Clinically compromised vertebral bodies at the affected level(s) due to any traumatic,&#xD;
             neoplastic, metabolic or infectious pathology;&#xD;
&#xD;
          -  Deformity of the spine that would compromise the implant, e.g. scoliosis of greater&#xD;
             than ten (10) degrees;&#xD;
&#xD;
          -  Morbid obesity defined as a body mass index &gt; 40 or a weight more than 100 lbs. over&#xD;
             ideal body weight;&#xD;
&#xD;
          -  DEXA bone density measured T score equal to or lower than - 2.0;&#xD;
&#xD;
          -  Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid&#xD;
             gland disorder and/or any other metabolic bone disease;&#xD;
&#xD;
          -  Active infection;&#xD;
&#xD;
          -  AIDS, HIV, or active hepatitis;&#xD;
&#xD;
          -  Rheumatoid arthritis or other autoimmune disease;&#xD;
&#xD;
          -  Tuberculosis active or in the past 3 years;&#xD;
&#xD;
          -  Active malignancy: unless treated with curative intent and there have been no clinical&#xD;
             signs or symptoms of the malignancy for at least 5 years;&#xD;
&#xD;
          -  Medical condntions requiring treatment with any drugs known to potentially interfere&#xD;
             with bone/soft tissue healing;&#xD;
&#xD;
          -  Pregnant or interested in becoming pregnant in the next 3 years;&#xD;
&#xD;
          -  Current chemical/alcohol dependency or significant psychosocial disturbance;&#xD;
&#xD;
          -  Cauda equina syndrome or neurogenic bowel/bladder dysfunction;&#xD;
&#xD;
          -  Severe arterial insufficiency of the legs, peripheral vascular disease;&#xD;
&#xD;
          -  Sustained pathologic fractures of the vertebra or multiple fractures of the vertebra&#xD;
             or hip;&#xD;
&#xD;
          -  Significant peripheral neuropathy;&#xD;
&#xD;
          -  Immunologically suppressed, received steroids &gt; 1 month out of the past year;&#xD;
&#xD;
          -  Insulin-dependent diabetes mellitus;&#xD;
&#xD;
          -  Life expectancy less than 3 years;&#xD;
&#xD;
          -  Waddell signs &gt; 3;&#xD;
&#xD;
          -  Currently involved in active spinal litigation OR&#xD;
&#xD;
          -  Subject is incarcerated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Masood Shafafy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queens Medical Centre Nottingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Masood Shafafy, MD</last_name>
    <phone>+44 (0)115 9249924</phone>
    <phone_ext>61024</phone_ext>
    <email>massod.shafafy@nuh.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Queens Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bronek Boszczyk, MD</last_name>
      <phone>+44 (0)115 9249924</phone>
      <email>bronek.boszczyk@nuh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>Masood Shafafy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>April 14, 2016</last_update_submitted>
  <last_update_submitted_qc>April 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 18, 2016</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>
  <!-- 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/NCT02234154
org study id: 1513-CL-TP-01 NOT UK
nct id: NCT02234154
lead sponsor: 
has dmc: No
This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for
      lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.
This study is being conducted to evaluate the TOPS™ SP System from ("TOPS™ System" or
      "TOPS"). TOPS is an alternative to spinal fusion and is designed to stabilize but not fuse
      the affected vertebral level to alleviate pain stemming from degenerative spondylolisthesis
      (abnormal/excessive movement of the vertebrae causing pain in the lower back and legs) and
      spinal stenosis (narrowing of the spinal canal resulting in compression of nerves producing
      symptoms of pain, numbness and tingling in the legs).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in ODI and Improvement in VAS leg score v
time frame: 24 months post implantation
description: Composite endpoint - Subjects who exhibit a reduction of 15 percent in their Oswestry Disability Index (ODI) score compared to their preoperative ODI score AND a reduction of at least 20mm (20% improvement) in either of their VAS Leg Score will be considered a success.
measure: Improvement in back and leg visual analog scales (VAS)
time frame: 24 month postoperatively
description: A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
measure: Improvement in ZCQ scores
time frame: 24 months postoperatively
description: A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
measure: Quality of life (SF-36)
time frame: 24 months postoperatively
description: A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
measure: Maintenance or improvement in neurological symptoms
time frame: 24 months postoperatively
description: A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
arm group label: TOPS System
arm group type: Other
description: Post Marketing Study
intervention type: Device
intervention name: TOPS System
description: Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.
arm group label: TOPS System
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Masood Shafafy, MD
role: Principal Investigator
affiliation: Queens Medical Centre Nottingham
last name: Masood Shafafy, MD
phone: +44 (0)115 9249924
phone ext: 61024
email: massod.shafafy@nuh.nhs.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Spondylolisthesis