<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/NCT04423120</url>
  </required_header>
  <id_info>
    <org_study_id>SECURE</org_study_id>
    <nct_id>NCT04423120</nct_id>
  </id_info>
  <brief_title>Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device</brief_title>
  <official_title>A Single Arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PainTEQ, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pacific Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PainTEQ, LLC</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PainTEQ study is a prospective, multi-site, prospective, single arm study intended to&#xD;
      collect clinical data outcomes data associated with the treatment of sacroiliac disease with&#xD;
      the LinQ fusion procedure. Data will be collected using self-report measures including the&#xD;
      visual analog scale (VAS) for pain assessment where the participant is asked to place a line&#xD;
      perpendicular to the VAS line at the point that represents their pain intensity. Using a&#xD;
      ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the&#xD;
      &quot;no pain&quot; anchor and the patient's mark, providing a range of scores from 0-100. Other&#xD;
      self-report questionnaires will be administered including the Oswestry Disablity Index (ODI)&#xD;
      to measure low-back pain and disability, and the Patient-Reported Outcomes Measurement&#xD;
      Information System 29 (PROMIS 29) to measure physical, mental, and social health and&#xD;
      well-being.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">March 13, 2020</start_date>
  <completion_date type="Anticipated">March 21, 2026</completion_date>
  <primary_completion_date type="Anticipated">March 21, 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline VAS Sacroiliac Joint (SIJ) pain by at least 20 millimeters</measure>
    <time_frame>Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.</time_frame>
    <description>A subject was considered a success if all of the following criteria were met&#xD;
1. Change from baseline VAS SIJ pain by at least 20 mm (Binary success failure composite end point) VAS is a vertical scale, where a higher score depicts more pain (100 mm maximum) and a lower scale depicts less pain (0 mm minimum)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absence of device related serious adverse events</measure>
    <time_frame>Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.</time_frame>
    <description>A subject was considered a success if all of the following criteria were met&#xD;
2. Absence of device related serious adverse events, (Binary success failure composite end point)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absence of neurological worsening related to the lumbosacral nerve roots</measure>
    <time_frame>Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.</time_frame>
    <description>A subject was considered a success if all of the following criteria were met&#xD;
3. Absence of neurological worsening related to the lumbosacral nerve roots, (Binary success failure composite end point)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain</measure>
    <time_frame>Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.</time_frame>
    <description>A subject was considered a success if all of the following criteria were met&#xD;
4. Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain (Binary success failure composite end point)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in VAS</measure>
    <time_frame>Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.</time_frame>
    <description>1. Change in baseline in VAS from baseline at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ODI</measure>
    <time_frame>Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.</time_frame>
    <description>2. Change in Oswestry Disability Index at 6 months follow up ODI assesses disability and has 10 sections, each with a point range from 0 (minimum) to 5 (maximum). A higher score translates to a higher percentage, meaning more disability (100% maximum). A lower score translates to a lower percentage, meaning less disability (0% minimum).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS29</measure>
    <time_frame>Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.</time_frame>
    <description>3. Change in PROMIS-29 at 6 months follow up. PROMIS 29 assesses pain intensity using a 0-10 numeric rating scale (11 point scale), where a higher score equates to more pain. Other health domains are scored using a Likert scale, where higher scores represent more of the specific domain being measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Global Impression of Change (PGIC)</measure>
    <time_frame>Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.</time_frame>
    <description>4. Change in Patient Satisfaction with PGIC PGIC is on a 7 point scale that depicts a patient's rating on their overall improvement. A lower score translates to a profound improvement and a higher score translates to a salvage improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Morphine milligram equivalent</measure>
    <time_frame>Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.</time_frame>
    <description>5. Change in MME usage at all time points</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Potential study participants will come from the existing patient population of the&#xD;
        investigators in each individual practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21-70&#xD;
&#xD;
          -  Patient has lower back pain for &gt;6 months inadequately responsive to conservative care&#xD;
&#xD;
          -  Patient has at least 3 of 4 physical examination maneuvers specific for the SI joint&#xD;
             (FABER, Gaenslen test, Stork/Gillete, and Yoman)&#xD;
&#xD;
          -  Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50%&#xD;
             after injection of local anesthetic into affected SI joint(s) with confirmed&#xD;
             arthrogram, within 30-60 min from injection&#xD;
&#xD;
          -  Degenerative sacroiliitis as SIJ mediated in in the context of either radiographic&#xD;
             evidence of SIJ degeneration, evident on computed tomography or Xrays or a history of&#xD;
             prior lumbar fusion.&#xD;
&#xD;
          -  SIJ disruption was defined in the study of as SIJ mediated pain in the context of&#xD;
             asymmetric widening of SIJ on CT or Xrays or the presence of significant contrast&#xD;
             leakage during diagnostic SIJ block&#xD;
&#xD;
          -  Baseline Oswestry Disability Index (ODI) score of at least 30%&#xD;
&#xD;
          -  Baseline Low back/buttock pain score of at least 50 on 0-100 mm visual analog scale&#xD;
&#xD;
          -  Patient has signed study-specific informed consent form&#xD;
&#xD;
          -  Patient has the necessary mental capacity to consent and participate and is physically&#xD;
             able to comply with study protocol requirements&#xD;
&#xD;
          -  Patient has medical insurance that covers this standard of care procedure and all&#xD;
             other anticipated and unanticipated procedure related care.&#xD;
&#xD;
          -  Patient's physician has decided that the best treatment for the patient's sacro-iliac&#xD;
             disease is the LinQ system and the patient has agreed to the treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to confirm that the pain is arising from the sacroiliac joint&#xD;
&#xD;
          -  Current severe back pain due to other causes, such as lumbar disc degeneration, lumbar&#xD;
             disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet&#xD;
             degeneration, lumbar radicular pain, and lumbar vertebral body fracture&#xD;
&#xD;
          -  SIJ pain secondary to inflammatory conditions, Other known sacroiliac pathology such&#xD;
             as: Sacral dysplasia, Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other&#xD;
             HLA-associated spondylo-arthropathy), Tumor, Infection, Acute fracture, and Crystal&#xD;
             arthropathy.&#xD;
&#xD;
          -  Radicular pain extending beyond the buttock ≥ 30mm on VAS&#xD;
&#xD;
          -  Has complete resolution of pain from the diagnostic SIJ injection lasting 30 days or&#xD;
             more&#xD;
&#xD;
          -  Has had an injection with corticosteroid into the index SIJ within the last 90 days&#xD;
&#xD;
          -  Has had any neuraxial injection with corticosteroid within the last 90 days&#xD;
&#xD;
          -  Has greater than 50% pain relief from diagnostic medial branch blocks at the L4/5&#xD;
             and/or L5/S1 levels&#xD;
&#xD;
          -  Has had a sacral radiofrequency ablation within the last 6 months&#xD;
&#xD;
          -  History of any hardware placement within the sacrum or sacroiliac joint&#xD;
&#xD;
          -  History of coccydynia or coccygectomy&#xD;
&#xD;
          -  Clinical diagnosis of discogenic pain at L4/5 and/or L5/S1&#xD;
&#xD;
          -  History of endometriosis or pudendal neuralgia&#xD;
&#xD;
          -  History of recent (&lt;1 year) major trauma to pelvis&#xD;
&#xD;
          -  Chronic rheumatologic condition (e.g., rheumatoid arthritis)&#xD;
&#xD;
          -  Any condition or anatomy that makes treatment with the Linq Implant System infeasible&#xD;
&#xD;
          -  Use of medications known to have detrimental effects on bone quality and soft-tissue&#xD;
             healing (metabolic bone disease, induced or idiopathic)&#xD;
&#xD;
          -  Prominent neurologic condition that would interfere with physical therapy&#xD;
&#xD;
          -  Current local or systemic infection that raises the risk of surgery&#xD;
&#xD;
          -  Patient currently receiving or seeking worker's compensation, disability remuneration,&#xD;
             and/or involved in injury litigation.&#xD;
&#xD;
          -  Patient is participating in an investigational study or has been involved in an&#xD;
             investigational study within 3 months prior to evaluation for participation&#xD;
&#xD;
          -  Patient with insurance coverage that does not cover the SI fusion*&#xD;
&#xD;
          -  Implanted intrathecal pain pump&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Calodeny, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Precision Spine Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Precision Spine Care</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 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>Chronic Pain</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 4, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT04423120/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04423120
org study id: SECURE
nct id: NCT04423120
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The PainTEQ study is a prospective, multi-site, prospective, single arm study intended to
      collect clinical data outcomes data associated with the treatment of sacroiliac disease with
      the LinQ fusion procedure. Data will be collected using self-report measures including the
      visual analog scale (VAS) for pain assessment where the participant is asked to place a line
      perpendicular to the VAS line at the point that represents their pain intensity. Using a
      ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the
      "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Other
      self-report questionnaires will be administered including the Oswestry Disablity Index (ODI)
      to measure low-back pain and disability, and the Patient-Reported Outcomes Measurement
      Information System 29 (PROMIS 29) to measure physical, mental, and social health and
      well-being.
observational model: Other
time perspective: Prospective
measure: Change from baseline VAS Sacroiliac Joint (SIJ) pain by at least 20 millimeters
time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
description: A subject was considered a success if all of the following criteria were met
1. Change from baseline VAS SIJ pain by at least 20 mm (Binary success failure composite end point) VAS is a vertical scale, where a higher score depicts more pain (100 mm maximum) and a lower scale depicts less pain (0 mm minimum)
measure: Absence of device related serious adverse events
time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
description: A subject was considered a success if all of the following criteria were met
2. Absence of device related serious adverse events, (Binary success failure composite end point)
measure: Absence of neurological worsening related to the lumbosacral nerve roots
time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
description: A subject was considered a success if all of the following criteria were met
3. Absence of neurological worsening related to the lumbosacral nerve roots, (Binary success failure composite end point)
measure: Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain
time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
description: A subject was considered a success if all of the following criteria were met
4. Absence of surgical reintervention (removal, revision reoperation or supplemental fixation) for SIJ pain (Binary success failure composite end point)
measure: Change in VAS
time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
description: 1. Change in baseline in VAS from baseline at 6 months
measure: Change in ODI
time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
description: 2. Change in Oswestry Disability Index at 6 months follow up ODI assesses disability and has 10 sections, each with a point range from 0 (minimum) to 5 (maximum). A higher score translates to a higher percentage, meaning more disability (100% maximum). A lower score translates to a lower percentage, meaning less disability (0% minimum).
measure: Change in PROMIS29
time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
description: 3. Change in PROMIS-29 at 6 months follow up. PROMIS 29 assesses pain intensity using a 0-10 numeric rating scale (11 point scale), where a higher score equates to more pain. Other health domains are scored using a Likert scale, where higher scores represent more of the specific domain being measured.
measure: Change in Patient Global Impression of Change (PGIC)
time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
description: 4. Change in Patient Satisfaction with PGIC PGIC is on a 7 point scale that depicts a patient's rating on their overall improvement. A lower score translates to a profound improvement and a higher score translates to a salvage improvement.
measure: Change in Morphine milligram equivalent
time frame: Comparisons will be done prior to baseline visit and 7-14 days post surgery, 1 month, 3 month, 6 month, and 12 month visits.
description: 5. Change in MME usage at all time points
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Aaron Calodeny, MD
role: Principal Investigator
affiliation: Precision Spine Care
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
provided document: 