<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/NCT04439032</url>
  </required_header>
  <id_info>
    <org_study_id>SF-100</org_study_id>
    <nct_id>NCT04439032</nct_id>
  </id_info>
  <brief_title>Artoss Prospective Spine Registry Outcomes</brief_title>
  <acronym>ASTRO</acronym>
  <official_title>Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Spinal Fusion Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Artoss Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Artoss Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective registry was designed as an observational study to ascertain how&#xD;
      commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion&#xD;
      as well as determining relevant patient outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multicenter prospective patient registry was developed with the aim of documenting how&#xD;
      spine and neurosurgeons are utilizing the NanoBone products along with relevant patient&#xD;
      outcomes. These outcomes include radiographic measures such as fusion outcome,&#xD;
      instrumentation integrity, and clinical outcomes (symptom and function improvement) based on&#xD;
      investigator and patient-based outcome assessments.&#xD;
&#xD;
      The primary objective of this study is to document and analyze the use of NanoBone products&#xD;
      in spine fusion surgery (as a stand-alone bone graft, or in combination with local bone only,&#xD;
      no other BGS or biologic product used) and determine both radiographic success and clinical&#xD;
      outcomes. All product related adverse events will be documented, tabulated, and summarized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">December 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Radiographic Success</measure>
    <time_frame>12-months</time_frame>
    <description>Evidence of bony bridging between vertebral endplates and/or transverse processes of bone grafted vertebrae or absence of motion between vertebral bodies or both.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety Evaluation</measure>
    <time_frame>12-months</time_frame>
    <description>Occurrence of Complications or Adverse Events</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Success</measure>
    <time_frame>12-months</time_frame>
    <description>Improvement from baseline in Visual Analog Scale (VAS) pain score (0= no pain, 10=worst possible pain)</description>
  </other_outcome>
  <other_outcome>
    <measure>Function</measure>
    <time_frame>12-months</time_frame>
    <description>Improvement from baseline in Oswestry Disability Index (ODI) or Neck Disability Index (NDI) Scale (0=no disability-100=totally disabled)</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">330</enrollment>
  <condition>Spinal Fusion</condition>
  <arm_group>
    <arm_group_label>Spine Fusion using NanoBone</arm_group_label>
    <description>All patients in the study will be drawn from the individual surgeons' practice. Patients will be candidates for spinal fusion surgery after having failed conservative treatment or will have had spinal fusion surgery but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NanoBone Bone Graft Substitute</intervention_name>
    <description>Synthetic, biodegradable bone grafting material that is composed of non-sintered nanocrystalline hydroxyapatite (HA) which is embedded in a silica gel matrix (amorphous SiO2). The ratio of HA/SiO2 has been chosen to optimize the rate of biodegradation for treatment of osseous defects in human bone. NanoBone does not contain any components of animal or human origin, eliminating the possibility of transmission of infection or disease.</description>
    <arm_group_label>Spine Fusion using NanoBone</arm_group_label>
    <other_name>nanoHA-SiO2</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients in the study will be drawn from the individual surgeons' practice. Patients&#xD;
        will be candidates for spinal fusion surgery after having failed conservative treatment or&#xD;
        will have had spinal fusion surgery but have not completed their standard of care follow-up&#xD;
        as determined by the surgeon's practice. In addition, the surgeon has determined that the&#xD;
        use of a NanoBone product is or was clinically necessary for the patient. The choice of a&#xD;
        NanoBone product is or was independent of this research project. Only patients who have had&#xD;
        NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria&#xD;
        will be included in the registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 18 years or older&#xD;
&#xD;
          -  Patient is diagnosed with a degenerative spine disorder requiring spinal fusion, has&#xD;
             failed conservative treatment, and has decided to undergo surgery.&#xD;
&#xD;
          -  The surgeon has determined that a NanoBone product is or was clinically indicated, and&#xD;
             will use or have used the product as a stand-alone bone graft substitute or in&#xD;
             combination with local autograft only (no iliac crest harvesting, other BGS, or&#xD;
             biologic {defined as containing growth factors, cytokines, proteins, or cells} used).&#xD;
&#xD;
          -  Patient capable of understanding the content of the Informed Consent Form&#xD;
&#xD;
          -  Patient willing and able to participate in the registry protocol including SOC&#xD;
             follow-up visits and clinical evaluations.&#xD;
&#xD;
          -  Patient who has agreed to participate in the registry by providing consent according&#xD;
             to the applicable local law and the Declaration of Helsinki.&#xD;
&#xD;
        Exclusion Criteria:• Severe vascular or neurological disease&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
&#xD;
          -  Severe degenerative disease (other than degenerative disc disease)&#xD;
&#xD;
          -  Severely impaired renal function&#xD;
&#xD;
          -  Hypercalcemia, abnormal calcium metabolism&#xD;
&#xD;
          -  Existing acute or chronic infections, especially at the site of the operation&#xD;
&#xD;
          -  Inflammatory bone disease such as osteomyelitis&#xD;
&#xD;
          -  Malignant tumors&#xD;
&#xD;
          -  Patients who are or plan to become pregnant.&#xD;
&#xD;
          -  Uncooperative patients who cannot or will not follow post-operative instruction,&#xD;
             including individuals who abuse drugs and/or alcohol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jim Cassidy, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Artoss Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OrthoArizona</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sonoran Spine</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SENTA Clinic</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hartford Health Care</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoBethesda</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sam Shamsnia MD Neurosurgery</name>
      <address>
        <city>Biloxi</city>
        <state>Mississippi</state>
        <zip>39532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://artossinc.com</url>
    <description>Sponsor Website</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bone Graft Substitute</keyword>
  <keyword>Spinal Fusion</keyword>
  <keyword>Degenerative Disc Disease</keyword>
  <keyword>Scoliosis</keyword>
  <keyword>Spine Deformity</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT04439032
org study id: SF-100
nct id: NCT04439032
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This prospective registry was designed as an observational study to ascertain how
      commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion
      as well as determining relevant patient outcomes.
This multicenter prospective patient registry was developed with the aim of documenting how
      spine and neurosurgeons are utilizing the NanoBone products along with relevant patient
      outcomes. These outcomes include radiographic measures such as fusion outcome,
      instrumentation integrity, and clinical outcomes (symptom and function improvement) based on
      investigator and patient-based outcome assessments.

      The primary objective of this study is to document and analyze the use of NanoBone products
      in spine fusion surgery (as a stand-alone bone graft, or in combination with local bone only,
      no other BGS or biologic product used) and determine both radiographic success and clinical
      outcomes. All product related adverse events will be documented, tabulated, and summarized.
observational model: Cohort
time perspective: Prospective
measure: Radiographic Success
time frame: 12-months
description: Evidence of bony bridging between vertebral endplates and/or transverse processes of bone grafted vertebrae or absence of motion between vertebral bodies or both.
measure: Safety Evaluation
time frame: 12-months
description: Occurrence of Complications or Adverse Events
measure: Clinical Success
time frame: 12-months
description: Improvement from baseline in Visual Analog Scale (VAS) pain score (0= no pain, 10=worst possible pain)
measure: Function
time frame: 12-months
description: Improvement from baseline in Oswestry Disability Index (ODI) or Neck Disability Index (NDI) Scale (0=no disability-100=totally disabled)
arm group label: Spine Fusion using NanoBone
description: All patients in the study will be drawn from the individual surgeons' practice. Patients will be candidates for spinal fusion surgery after having failed conservative treatment or will have had spinal fusion surgery but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon has determined that the use of a NanoBone product is or was clinically necessary for the patient.
intervention type: Other
intervention name: NanoBone Bone Graft Substitute
description: Synthetic, biodegradable bone grafting material that is composed of non-sintered nanocrystalline hydroxyapatite (HA) which is embedded in a silica gel matrix (amorphous SiO2). The ratio of HA/SiO2 has been chosen to optimize the rate of biodegradation for treatment of osseous defects in human bone. NanoBone does not contain any components of animal or human origin, eliminating the possibility of transmission of infection or disease.
arm group label: Spine Fusion using NanoBone
other name: nanoHA-SiO2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Jim Cassidy, PhD
role: Study Director
affiliation: Artoss Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://artossinc.com
description: Sponsor Website
responsible party type: Sponsor
sharing ipd: No