<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/NCT04503759</url>
  </required_header>
  <id_info>
    <org_study_id>HAF002</org_study_id>
    <nct_id>NCT04503759</nct_id>
  </id_info>
  <brief_title>Artoss Foot and Ankle Surgery Registry</brief_title>
  <acronym>ARK</acronym>
  <official_title>Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone in Foot and Ankle 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 products are being used by surgeons performing foot and ankle&#xD;
      surgery which involves bone grafting, 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;
      surgeons are utilizing NanoBone products in foot and ankle surgery along with relevant&#xD;
      patient outcomes. These outcomes include radiographic measures such as fusion or graft&#xD;
      consolidation success, instrumentation integrity, and clinical outcomes (symptom and function&#xD;
      improvement) based on 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 foot and ankle surgery (as a stand-alone bone graft, no other local bone, autograft, bone&#xD;
      graft substitute, or biologic product used) and determine both radiographic success and&#xD;
      clinical outcomes. All product related adverse events will be documented, tabulated, and&#xD;
      summarized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Radiographic Success</measure>
    <time_frame>6-months</time_frame>
    <description>Fusion/Graft Consolidation: Evidence of bony (osseous) bridging between the graft material and the patient's bone in the segment requiring fusion or reconstruction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety Evaluation</measure>
    <time_frame>6-months</time_frame>
    <description>Occurrence of Complications or Adverse Events</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Success</measure>
    <time_frame>6-months</time_frame>
    <description>Change 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>6-months</time_frame>
    <description>Change from baseline in Foot and Ankle Ability Measure (FAAM)</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Arthritis Foot</condition>
  <condition>Trauma Injury</condition>
  <condition>Deformity; Bone</condition>
  <arm_group>
    <arm_group_label>Foot and Ankle Surgery using NanoBone</arm_group_label>
    <description>All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already scheduled for foot and ankle surgery after having failed conservative treatment, or will have had foot and ankle surgery using NanoBone products 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. The choice of a NanoBone product, as well as the surgery, is or was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.</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>Foot and Ankle Surgery 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 among those already scheduled for foot and ankle surgery after having failed&#xD;
        conservative treatment, or will have had foot and ankle surgery using NanoBone products but&#xD;
        have not completed their standard of care follow-up as determined by the surgeon's&#xD;
        practice. In addition, the surgeon has determined that the use of a NanoBone product is or&#xD;
        was clinically necessary for the patient. The choice of a NanoBone product, as well as the&#xD;
        surgery, 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 or was diagnosed with a pathology of the foot or ankle, having failed&#xD;
             conservative treatment, and surgeon has determined that surgery with bone graft is&#xD;
             medically necessary.&#xD;
&#xD;
          -  The surgeon has determined that NanoBone is or was clinically indicated.&#xD;
&#xD;
          -  NanoBone will be or was used as a stand-alone bone graft (no autograft, other bone&#xD;
             graft substitute, or biologic planned or 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 the&#xD;
             surgeon's standard 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:&#xD;
&#xD;
          -  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>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jim Cassidy, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Artoss Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Foot and Ankle Institute</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Orthopedic Foot &amp; Ankle Center</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Orthopedic Institute</name>
      <address>
        <city>Joliet</city>
        <state>Illinois</state>
        <zip>60435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morrison Hospital</name>
      <address>
        <city>Morrison</city>
        <state>Illinois</state>
        <zip>61270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podiatry Associates of Indiana</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46254</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hoosier Foot and Ankle</name>
      <address>
        <city>Kokomo</city>
        <state>Indiana</state>
        <zip>46901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Iowa Clinic</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Associates of Duluth</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</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>Arthritis</mesh_term>
    <mesh_term>Congenital Abnormalities</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/NCT04503759
org study id: HAF002
nct id: NCT04503759
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 products are being used by surgeons performing foot and ankle
      surgery which involves bone grafting, as well as determining relevant patient outcomes.
This multicenter prospective patient registry was developed with the aim of documenting how
      surgeons are utilizing NanoBone products in foot and ankle surgery along with relevant
      patient outcomes. These outcomes include radiographic measures such as fusion or graft
      consolidation success, 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 foot and ankle surgery (as a stand-alone bone graft, no other local bone, autograft, bone
      graft substitute, 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: 6-months
description: Fusion/Graft Consolidation: Evidence of bony (osseous) bridging between the graft material and the patient's bone in the segment requiring fusion or reconstruction.
measure: Safety Evaluation
time frame: 6-months
description: Occurrence of Complications or Adverse Events
measure: Clinical Success
time frame: 6-months
description: Change from baseline in Visual Analog Scale (VAS) pain score (0=no pain, 10=worst possible pain
measure: Function
time frame: 6-months
description: Change from baseline in Foot and Ankle Ability Measure (FAAM)
arm group label: Foot and Ankle Surgery using NanoBone
description: All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already scheduled for foot and ankle surgery after having failed conservative treatment, or will have had foot and ankle surgery using NanoBone products 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. The choice of a NanoBone product, as well as the surgery, is or was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.
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: Foot and Ankle Surgery using NanoBone
other name: nanoHA-SiO2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jim Cassidy, PhD
role: Study Director
affiliation: Artoss Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Congenital Abnormalities