<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/NCT03290586</url>
  </required_header>
  <id_info>
    <org_study_id>FLO-001</org_study_id>
    <nct_id>NCT03290586</nct_id>
  </id_info>
  <brief_title>Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis</brief_title>
  <official_title>Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis; the Evaluation of a Novel, Single Use Sterile, Disposable Delivery System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JEM Research Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Flower Orthopedics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>JEM Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a longitudinal, multi-center study to be conducted in at least five institutions from&#xD;
      the private surgeon offices. These surgeons will collect data from X-rays, wound&#xD;
      complications \and hardware complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2017</start_date>
  <completion_date type="Actual">April 3, 2018</completion_date>
  <primary_completion_date type="Actual">April 3, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Union Rates</measure>
    <time_frame>12 months</time_frame>
    <description>Confirm union rates comparable to existing outcomes complications with our proposed construct.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hardware Failures</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluate hardware failures with our proposed construct.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluate complications with the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost Data</measure>
    <time_frame>12 months</time_frame>
    <description>Review cost data using the Flower Orthopedics single use, sterile disposable fixation construct performed in an outpatient surgical setting compared to in patient hospital setting.</description>
  </secondary_outcome>
  <enrollment type="Actual">69</enrollment>
  <condition>First Metatarsophalangeal Joint Arthritis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Flower Cube</intervention_name>
    <description>single use, sterile disposable fixation construct</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from the surgeons' private practices. These patients have&#xD;
        already met the criteria for surgical intervention and have agreed to undergo the operative&#xD;
        procedure and postoperative management.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Painful Hallux Limitus or Rigidus&#xD;
&#xD;
          -  Painful Geriatric Hallux Valgus&#xD;
&#xD;
          -  Failed prior 1st MTP joint arthroplasty (hemi-total)&#xD;
&#xD;
          -  Arthritis of any etiology other than degenerative causes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  Pregnant Females&#xD;
&#xD;
          -  Active or prior infection at the target joint&#xD;
&#xD;
          -  Immunocompromised patients&#xD;
&#xD;
          -  Patients unwilling to sign informed consent&#xD;
&#xD;
          -  Patient's unwilling to participate the in study protocol&#xD;
&#xD;
          -  Subject with known sensitivity to titanium implants&#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>John Levin, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>JEM Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>JEM Research Institute</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>JEM Research Institute</investigator_affiliation>
    <investigator_full_name>John Levin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <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/NCT03290586
org study id: FLO-001
nct id: NCT03290586
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a longitudinal, multi-center study to be conducted in at least five institutions from
      the private surgeon offices. These surgeons will collect data from X-rays, wound
      complications \and hardware complications.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Union Rates
time frame: 12 months
description: Confirm union rates comparable to existing outcomes complications with our proposed construct.
measure: Hardware Failures
time frame: 12 months
description: Evaluate hardware failures with our proposed construct.
measure: Complications
time frame: 12 months
description: Evaluate complications with the procedure
measure: Cost Data
time frame: 12 months
description: Review cost data using the Flower Orthopedics single use, sterile disposable fixation construct performed in an outpatient surgical setting compared to in patient hospital setting.
intervention type: Device
intervention name: Flower Cube
description: single use, sterile disposable fixation construct
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Levin, DPM
role: Principal Investigator
affiliation: JEM Research Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: JEM Research Institute
investigator full name: John Levin
investigator title: Principal Investigator
mesh term: Arthritis
sharing ipd: No