<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/NCT03780452</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300002689</org_study_id>
    <nct_id>NCT03780452</nct_id>
  </id_info>
  <brief_title>Compression Nail for Tibiocalcaneal Arthrodesis</brief_title>
  <official_title>Use of Dynamic Intramedullary Compression Nail for Tibiocalcaneal Arthrodesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MedShape, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      The purpose of this study is to determine the clinical efficacy of a novel dynamic&#xD;
      compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This proposal is a collaborative effort of MedShape Inc. It is a prospective investigation to&#xD;
      assess the clinical outcomes of patients with a tibiotalocalcaneal arthrodesis with the&#xD;
      Dynamic Compression Intramedullary Nail (DynaNail). We are planning to enroll 30 patients.&#xD;
      The assignment of the device is at the discretion of the standard of care provider, not the&#xD;
      study investigator.&#xD;
&#xD;
      Patients with end-stage tibiotalar (ankle) and talocalcaneal (subtalar) joint arthritis from&#xD;
      any etiology will be asked to enroll in the study. After informed consent, the patients will&#xD;
      be asked to complete the following patient reported outcomes questionnaires (standard of care&#xD;
      for all patients in the Foot and Ankle section): 100mm VAS for pain, Short form-36 (SF-36),&#xD;
      and the Foot and Ankle Ability Measure (FAAM). After informed consent, they will then be&#xD;
      scheduled for surgery in a routine fashion. REDCap database will be used to allow on-line&#xD;
      data entry.&#xD;
&#xD;
      The following surgical procedure steps and follow-ups are standard of care at the University&#xD;
      of Alabama at Birmingham. The surgical procedure will involve both tibiotalar and&#xD;
      talocalcaneal joint preparation through any approach (lateral, posterior, anterior with sinus&#xD;
      tarsi). The use of supplemental bone graft is at the discretion of the treating surgeon but&#xD;
      must be documented. The MedShape DynaNail will then be inserted according to the&#xD;
      manufacturer's technique. The patient will be placed in a short leg splint and kept&#xD;
      non-weight bearing. The patient will be discharged from the hospital when medically ready and&#xD;
      follow-up in two weeks.&#xD;
&#xD;
      At two weeks, the patient will return to clinic for a standard of care visit and their splint&#xD;
      will be removed. A non-weight bearing lateral radiograph of the hind foot will be taken to&#xD;
      assess the amount of travel of the compressive element. This radiograph is not standard of&#xD;
      care. The patient will be placed in a non-weight bearing cast. The patient will then be asked&#xD;
      to return in two weeks (4 weeks post-operatively). This visit is not standard of care. At&#xD;
      this time another non-weight bearing lateral radiograph will be taken to assess the amount of&#xD;
      travel of the compressive element. The patient will be asked to return at 6 weeks, 3 months,&#xD;
      6 months, 12 months, and 24 months after surgery as is standard of care for this surgery. At&#xD;
      each of these time-points, the same patient specific outcome questionnaires will be&#xD;
      administered. For any non- standard of care radiographs patients will be asked to take a&#xD;
      urine pregnancy test prior to any radiographs being taken.&#xD;
&#xD;
      Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon,&#xD;
      his clinical fellow, or his physician assistant based on clinical exam and radiographic&#xD;
      findings. Inclusion criteria include anyone over age 18 who has ankle and subtalar arthritis&#xD;
      and has failed nonoperative management. Typically, these patients have multiple medical&#xD;
      comorbidities and therefore the only exclusion criteria will be patients who are not healthy&#xD;
      enough to undergo surgery. Patients of all racial, religious, and cultural backgrounds will&#xD;
      be included in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 15, 2020</start_date>
  <completion_date type="Anticipated">January 10, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 10, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>0 - 24 months postoperatively</time_frame>
    <description>Visual Analog Scale (VAS). Patients will disclose their pain level using the Visual Analog Scale, which measures pain on a scale of 0 - 100, with 0 indicating no pain and 100 indicating severe pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional assessment</measure>
    <time_frame>0 - 24 months postoperatively</time_frame>
    <description>Foot and Ankle Ability Measure (FAAM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Functional Assessment</measure>
    <time_frame>0 - 24 months postoperatively</time_frame>
    <description>Short Form 36 (SF-36).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fusion, as measured by radiograph and CT scan</measure>
    <time_frame>0 - 24 months postoperative</time_frame>
    <description>radiographs taken Pre-operatively, 2 weeks, 4 weeks, 6 weeks, 3 Months, 6 Months, 12 Months and 24 Months. A CT scan will be done at 6 months.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Subtalar Arthritis</condition>
  <condition>Ankle Arthritis</condition>
  <arm_group>
    <arm_group_label>Tibiotalocalcaneal arthrodesis with DynaNail</arm_group_label>
    <description>Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>novel dynamic compression intramedullary nail</intervention_name>
    <description>Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.</description>
    <arm_group_label>Tibiotalocalcaneal arthrodesis with DynaNail</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be identified in the clinic by an attending orthopaedic foot and ankle&#xD;
        surgeon, his clinical fellow, or his physician assistant based on clinical exam and&#xD;
        radiographic findings. Inclusion criteria include anyone over age 18 who has ankle and&#xD;
        subtalar arthritis and has failed nonoperative management. Typically, these patients have&#xD;
        multiple medical comorbidities and therefore the only exclusion criteria will be patients&#xD;
        who are not healthy enough to undergo surgery. Patients of all racial, religious, and&#xD;
        cultural backgrounds will be included in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over the age of 18&#xD;
&#xD;
          -  Ankle and Subtalar arthritis&#xD;
&#xD;
          -  Failed non-operative management&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not meet the minimum age of 18 years.&#xD;
&#xD;
          -  patients who are not eligible to undergo surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ashish shah, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ashish B Shah, M.D.</last_name>
    <phone>205-930-8339</phone>
    <email>ashishshah@uabmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aaradhana J Jha, M.D.</last_name>
    <phone>617-378-5116</phone>
    <email>aaradhana.jha@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashish Shah, MD</last_name>
      <phone>205-930-6722</phone>
      <email>ashishshah@uabmc.edu</email>
    </contact>
    <contact_backup>
      <last_name>felisa guess</last_name>
      <phone>2059306722</phone>
      <email>fguess@ubamc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Ashish Shah</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>intramedullary nail</keyword>
  <keyword>arthrodesis</keyword>
  <keyword>subtalar</keyword>
  <keyword>tibiotalar</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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/NCT03780452
org study id: IRB-300002689
nct id: NCT03780452
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine the clinical efficacy of a novel dynamic
      compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis
This proposal is a collaborative effort of MedShape Inc. It is a prospective investigation to
      assess the clinical outcomes of patients with a tibiotalocalcaneal arthrodesis with the
      Dynamic Compression Intramedullary Nail (DynaNail). We are planning to enroll 30 patients.
      The assignment of the device is at the discretion of the standard of care provider, not the
      study investigator.

      Patients with end-stage tibiotalar (ankle) and talocalcaneal (subtalar) joint arthritis from
      any etiology will be asked to enroll in the study. After informed consent, the patients will
      be asked to complete the following patient reported outcomes questionnaires (standard of care
      for all patients in the Foot and Ankle section): 100mm VAS for pain, Short form-36 (SF-36),
      and the Foot and Ankle Ability Measure (FAAM). After informed consent, they will then be
      scheduled for surgery in a routine fashion. REDCap database will be used to allow on-line
      data entry.

      The following surgical procedure steps and follow-ups are standard of care at the University
      of Alabama at Birmingham. The surgical procedure will involve both tibiotalar and
      talocalcaneal joint preparation through any approach (lateral, posterior, anterior with sinus
      tarsi). The use of supplemental bone graft is at the discretion of the treating surgeon but
      must be documented. The MedShape DynaNail will then be inserted according to the
      manufacturer's technique. The patient will be placed in a short leg splint and kept
      non-weight bearing. The patient will be discharged from the hospital when medically ready and
      follow-up in two weeks.

      At two weeks, the patient will return to clinic for a standard of care visit and their splint
      will be removed. A non-weight bearing lateral radiograph of the hind foot will be taken to
      assess the amount of travel of the compressive element. This radiograph is not standard of
      care. The patient will be placed in a non-weight bearing cast. The patient will then be asked
      to return in two weeks (4 weeks post-operatively). This visit is not standard of care. At
      this time another non-weight bearing lateral radiograph will be taken to assess the amount of
      travel of the compressive element. The patient will be asked to return at 6 weeks, 3 months,
      6 months, 12 months, and 24 months after surgery as is standard of care for this surgery. At
      each of these time-points, the same patient specific outcome questionnaires will be
      administered. For any non- standard of care radiographs patients will be asked to take a
      urine pregnancy test prior to any radiographs being taken.

      Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon,
      his clinical fellow, or his physician assistant based on clinical exam and radiographic
      findings. Inclusion criteria include anyone over age 18 who has ankle and subtalar arthritis
      and has failed nonoperative management. Typically, these patients have multiple medical
      comorbidities and therefore the only exclusion criteria will be patients who are not healthy
      enough to undergo surgery. Patients of all racial, religious, and cultural backgrounds will
      be included in this study.
observational model: Case-Only
time perspective: Prospective
measure: Pain assessment
time frame: 0 - 24 months postoperatively
description: Visual Analog Scale (VAS). Patients will disclose their pain level using the Visual Analog Scale, which measures pain on a scale of 0 - 100, with 0 indicating no pain and 100 indicating severe pain.
measure: functional assessment
time frame: 0 - 24 months postoperatively
description: Foot and Ankle Ability Measure (FAAM)
measure: Change in Functional Assessment
time frame: 0 - 24 months postoperatively
description: Short Form 36 (SF-36).
measure: Fusion, as measured by radiograph and CT scan
time frame: 0 - 24 months postoperative
description: radiographs taken Pre-operatively, 2 weeks, 4 weeks, 6 weeks, 3 Months, 6 Months, 12 Months and 24 Months. A CT scan will be done at 6 months.
arm group label: Tibiotalocalcaneal arthrodesis with DynaNail
description: Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail
intervention type: Device
intervention name: novel dynamic compression intramedullary nail
description: Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
arm group label: Tibiotalocalcaneal arthrodesis with DynaNail
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
healthy volunteers: No
last name: ashish shah, md
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Ashish B Shah, M.D.
phone: 205-930-8339
email: ashishshah@uabmc.edu
last name: Aaradhana J Jha, M.D.
phone: 617-378-5116
email: aaradhana.jha@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Ashish Shah
investigator title: Primary Investigator
mesh term: Arthritis