<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/NCT03824444</url>
  </required_header>
  <id_info>
    <org_study_id>A2935-R</org_study_id>
    <nct_id>NCT03824444</nct_id>
  </id_info>
  <brief_title>EFS Functional Expectations of Transhumeral Percutaneous OI Patients</brief_title>
  <acronym>AEA PODS</acronym>
  <official_title>Functional Expectations of Transhumeral Percutaneous Osseointegration Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      An FDA Early Feasibility Study (EFS) allows for early clinical evaluation of devices to&#xD;
      provide proof of principle and initial clinical safety data. The Primary Aim of this proposal&#xD;
      is to perform an FDA guided EFS of a percutaneous osseointegrated (OI) docking system for&#xD;
      patients with transhumeral (above elbow) amputations, establishing its initial safety.&#xD;
      Success of the Primary Aim (Safety) will be determined over a one year follow-up period by&#xD;
      observing the rate of patients successfully using their device without removal. The Secondary&#xD;
      Aim of this proposal is to quantify the functional effectiveness of the OI device, giving&#xD;
      specific attention to protocol differences required for male and female patients. Success for&#xD;
      the Secondary Aim (Functional Effectiveness) will be to determine functional improvement with&#xD;
      the device compared to the pre-operative performance. This will be the first longitudinal&#xD;
      analyses to evaluate the percutaneous OI devices on objective functionality measures of&#xD;
      transhumeral amputation individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An FDA Early Feasibility Study (EFS) allows &quot;for early clinical evaluation of devices to&#xD;
      provide proof of principle and initial clinical safety data.&quot; Over the past four years, the&#xD;
      team has performed the first EFS clinical trial of a percutaneous osseointegrated (OI)&#xD;
      docking system for patients with transfemoral amputations. As of December 1, 2017, 10&#xD;
      transfemoral VA patients received the device and are ambulating successfully for up to&#xD;
      36-months with positive safety and functional results. Currently, the EFS safety and&#xD;
      functionality data are being used to target a pivotal study of the transfemoral device to&#xD;
      obtain Premarket Approval (PMA) that will result in the broad clinical introduction of the&#xD;
      transfemoral OI device within the US. However, transhumeral patients are currently&#xD;
      underserved by prosthetic technologies. Nearly 60% of transhumeral patients limit their use&#xD;
      of suspension-based prostheses and upwards of 30% of upper-limb suspension-type prosthetic&#xD;
      devices are completely abandoned by both the VA and the military patient populations-with&#xD;
      abandonment of the prosthesis most common among women. The overarching goal of this proposal&#xD;
      is to maximize the functional recovery of US Veteran, military, and civilian patients with&#xD;
      transhumeral limb loss. The investigators believe that this can be done by bringing FDA&#xD;
      approved percutaneous OI devices to this patient population. Over the past 3 years, the&#xD;
      investigators developed a unique percutaneous OI device, known here as PODS, specifically for&#xD;
      transhumeral patients using an evidence based approach.&#xD;
&#xD;
      The Primary Aim of this proposal is to perform an FDA guided EFS of the PODS device for&#xD;
      transhumeral patients, establishing its initial clinical safety. Transhumeral patients will&#xD;
      be recruited to the Salt Lake City (SLC) VA for in-depth consultation and functional&#xD;
      evaluation. Recruited candidates will undergo a full clinical evaluation of the residual&#xD;
      limb. Functional assessments, focusing on activities of daily living (ADL), and evaluation of&#xD;
      joint and terminal device biomechanics will be collected with their socket-prosthetic device&#xD;
      (time = 0). These data will be used for final patient selection (N=10) for inclusion in the&#xD;
      FDA EFS clinical trial. The EFS patients will be brought back to the SLC VA, admitted to the&#xD;
      hospital, and have the Stage 1 surgery to receive the PODS endoprosthetic device, and then&#xD;
      discharged to home. Approximately 4 weeks later, patients will return to the SLC VA and have&#xD;
      the Stage 2 procedure performed to place the percutaneous post and attach their prosthetic&#xD;
      device. Post-operatively, wound healing will be monitored at the percutaneous site. Patients&#xD;
      will be discharged from the hospital to continue outpatient rehabilitation. Periodically&#xD;
      (time = 3, 6, and 12 months) following the Stage 2 procedure, patients will be brought back&#xD;
      to the SLC VA for assessment of their residual bone, soft tissues and device. The functional&#xD;
      assessments will be repeated with their PODS device at each follow-up visit. Success of the&#xD;
      Primary Aim (Safety) will be determined for the 1-year follow-up period with patients&#xD;
      successfully using their PODS devices with no device removal due to deep bone infections,&#xD;
      aseptic loosening, or atraumatic fracture.&#xD;
&#xD;
      The Secondary Aim of this proposal is to quantify the functional effectiveness of the PODS&#xD;
      device, giving specific attention to protocol differences required for male and female&#xD;
      patients. Success for the Secondary Aim (Functional Effectiveness) will be to quantify the&#xD;
      degree to which patients achieve functional improvement with the PODS device compared to the&#xD;
      pre-operative performance. These data will be the first longitudinal analyses to evaluate the&#xD;
      impact of percutaneous OI prostheses on objective functionality measures of these&#xD;
      transhumeral amputation individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 1, 2024</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single Group</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device rate of safety</measure>
    <time_frame>1 year</time_frame>
    <description>Device safety will be determined for the one year follow-up period by reporting the rate (number of participants with) device removal due to deep bone infections, aseptic loosening, or atraumatic fracture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectivenss of device to increase in function</measure>
    <time_frame>1 year</time_frame>
    <description>Success for the Secondary Aim (Functional Effectiveness) will be quantified by reporting patients who achieve functional improvement scores on objective measures with the PODS device compared to their pre-operative values.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Transhumeral Amputation</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implant and followup</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PODS</intervention_name>
    <description>Percutaneous Osseointegrated device for transhumeral patients</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A subject will be included in the study if he/she meets all of the following criteria:&#xD;
&#xD;
          -  Has a unilateral or bilateral transhumeral amputation and is at least 18 years of age&#xD;
&#xD;
          -  Has previously used, or is currently using, a prosthesis with a socket-based system&#xD;
&#xD;
          -  Is willing, able, and committed to participate in all evaluations for the study&#xD;
&#xD;
          -  Can provide IRB approved written informed consent to participate&#xD;
&#xD;
          -  Is willing to travel to Salt Lake City, Utah for a 3-day study funded visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A subject will be excluded from the study if he/she meets any of these criteria:&#xD;
&#xD;
          -  Is pregnant at the time of visit (Excluded due to radiation exposure from&#xD;
             CT/DEXA/Xray)&#xD;
&#xD;
          -  Is currently receiving renal dialysis&#xD;
&#xD;
          -  Has muscular, neurologic, or vascular deficiencies that affect the bone or soft tissue&#xD;
             of an affected extremity(ies)&#xD;
&#xD;
          -  Has, in the consensus of the investigators, physical limitations or other medical&#xD;
             conditions that may prevent the subject from being an appropriate study candidate,&#xD;
             i.e.:&#xD;
&#xD;
               -  other disease processes&#xD;
&#xD;
               -  mental incapacity&#xD;
&#xD;
               -  substance abuse (masking pain)&#xD;
&#xD;
               -  vulnerable subject population)&#xD;
&#xD;
          -  Has cardiac or pulmonary condition limiting functional abilities&#xD;
&#xD;
          -  Subject is a prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kent N. Bachus, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Salt Lake City Health Care System, Salt Lake City, UT</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kent N Bachus, PhD</last_name>
    <phone>(801) 582-1565</phone>
    <email>kent.bachus@hsc.utah.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarina K Sinclair, PhD</last_name>
    <phone>(801) 582-1565</phone>
    <phone_ext>4330</phone_ext>
    <email>sarina.sinclair@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA Salt Lake City Health Care System, Salt Lake City, UT</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84148-0001</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Kent N Bachus, PhD</last_name>
      <phone>801-582-1565</phone>
      <email>kent.bachus@hsc.utah.edu</email>
    </contact>
    <contact_backup>
      <last_name>Noel G Carlson, PhD</last_name>
      <phone>(801) 582-1565</phone>
      <phone_ext>5251</phone_ext>
      <email>Noel.Carlson@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Kent N. Bachus, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>humerus</keyword>
  <keyword>amputee</keyword>
  <keyword>Amputation</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/NCT03824444
org study id: A2935-R
nct id: NCT03824444
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
An FDA Early Feasibility Study (EFS) allows for early clinical evaluation of devices to
      provide proof of principle and initial clinical safety data. The Primary Aim of this proposal
      is to perform an FDA guided EFS of a percutaneous osseointegrated (OI) docking system for
      patients with transhumeral (above elbow) amputations, establishing its initial safety.
      Success of the Primary Aim (Safety) will be determined over a one year follow-up period by
      observing the rate of patients successfully using their device without removal. The Secondary
      Aim of this proposal is to quantify the functional effectiveness of the OI device, giving
      specific attention to protocol differences required for male and female patients. Success for
      the Secondary Aim (Functional Effectiveness) will be to determine functional improvement with
      the device compared to the pre-operative performance. This will be the first longitudinal
      analyses to evaluate the percutaneous OI devices on objective functionality measures of
      transhumeral amputation individuals.
An FDA Early Feasibility Study (EFS) allows "for early clinical evaluation of devices to
      provide proof of principle and initial clinical safety data." Over the past four years, the
      team has performed the first EFS clinical trial of a percutaneous osseointegrated (OI)
      docking system for patients with transfemoral amputations. As of December 1, 2017, 10
      transfemoral VA patients received the device and are ambulating successfully for up to
      36-months with positive safety and functional results. Currently, the EFS safety and
      functionality data are being used to target a pivotal study of the transfemoral device to
      obtain Premarket Approval (PMA) that will result in the broad clinical introduction of the
      transfemoral OI device within the US. However, transhumeral patients are currently
      underserved by prosthetic technologies. Nearly 60% of transhumeral patients limit their use
      of suspension-based prostheses and upwards of 30% of upper-limb suspension-type prosthetic
      devices are completely abandoned by both the VA and the military patient populations-with
      abandonment of the prosthesis most common among women. The overarching goal of this proposal
      is to maximize the functional recovery of US Veteran, military, and civilian patients with
      transhumeral limb loss. The investigators believe that this can be done by bringing FDA
      approved percutaneous OI devices to this patient population. Over the past 3 years, the
      investigators developed a unique percutaneous OI device, known here as PODS, specifically for
      transhumeral patients using an evidence based approach.

      The Primary Aim of this proposal is to perform an FDA guided EFS of the PODS device for
      transhumeral patients, establishing its initial clinical safety. Transhumeral patients will
      be recruited to the Salt Lake City (SLC) VA for in-depth consultation and functional
      evaluation. Recruited candidates will undergo a full clinical evaluation of the residual
      limb. Functional assessments, focusing on activities of daily living (ADL), and evaluation of
      joint and terminal device biomechanics will be collected with their socket-prosthetic device
      (time = 0). These data will be used for final patient selection (N=10) for inclusion in the
      FDA EFS clinical trial. The EFS patients will be brought back to the SLC VA, admitted to the
      hospital, and have the Stage 1 surgery to receive the PODS endoprosthetic device, and then
      discharged to home. Approximately 4 weeks later, patients will return to the SLC VA and have
      the Stage 2 procedure performed to place the percutaneous post and attach their prosthetic
      device. Post-operatively, wound healing will be monitored at the percutaneous site. Patients
      will be discharged from the hospital to continue outpatient rehabilitation. Periodically
      (time = 3, 6, and 12 months) following the Stage 2 procedure, patients will be brought back
      to the SLC VA for assessment of their residual bone, soft tissues and device. The functional
      assessments will be repeated with their PODS device at each follow-up visit. Success of the
      Primary Aim (Safety) will be determined for the 1-year follow-up period with patients
      successfully using their PODS devices with no device removal due to deep bone infections,
      aseptic loosening, or atraumatic fracture.

      The Secondary Aim of this proposal is to quantify the functional effectiveness of the PODS
      device, giving specific attention to protocol differences required for male and female
      patients. Success for the Secondary Aim (Functional Effectiveness) will be to quantify the
      degree to which patients achieve functional improvement with the PODS device compared to the
      pre-operative performance. These data will be the first longitudinal analyses to evaluate the
      impact of percutaneous OI prostheses on objective functionality measures of these
      transhumeral amputation individuals.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Group
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Device rate of safety
time frame: 1 year
description: Device safety will be determined for the one year follow-up period by reporting the rate (number of participants with) device removal due to deep bone infections, aseptic loosening, or atraumatic fracture
measure: Effectivenss of device to increase in function
time frame: 1 year
description: Success for the Secondary Aim (Functional Effectiveness) will be quantified by reporting patients who achieve functional improvement scores on objective measures with the PODS device compared to their pre-operative values.
arm group label: Treatment
arm group type: Experimental
description: Implant and followup
intervention type: Device
intervention name: PODS
description: Percutaneous Osseointegrated device for transhumeral patients
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kent N. Bachus, PhD
role: Principal Investigator
affiliation: VA Salt Lake City Health Care System, Salt Lake City, UT
last name: Kent N Bachus, PhD
phone: (801) 582-1565
email: kent.bachus@hsc.utah.edu
last name: Sarina K Sinclair, PhD
phone: (801) 582-1565
phone ext: 4330
email: sarina.sinclair@va.gov
facility: 
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No