<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/NCT03307499</url>
  </required_header>
  <id_info>
    <org_study_id>HPM1701.000-M</org_study_id>
    <nct_id>NCT03307499</nct_id>
  </id_info>
  <brief_title>NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery</brief_title>
  <official_title>Post-market, Prospective Evaluation of Human Placental Membrane Tissue Used as an Adjunct for Foot and Ankle Tendon Surgery in Patients With Chronic Tendinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CryoLife, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CryoLife</source>
  <oversight_info>
    <has_dmc>No</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 study is a prospective, single center, postmarket study to evaluate the safety and&#xD;
      effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, single center, postmarket study to evaluate the safety and&#xD;
      effectiveness of NeoPatch used as a tissue cover for chronically injured tendons requiring&#xD;
      surgical revision. NeoPatch is a tissue covering derived from terminally sterilized,&#xD;
      dehydrated human placental membrane tissue comprised of both amnion and chorion. Candidates&#xD;
      for this study are patients presenting with chronic tendon pain that are being evaluated for&#xD;
      primary tendon revision surgery following failure of standard of care or immediate need for&#xD;
      surgery, as determined by the investigator. Consented patients will receive NeoPatch as an&#xD;
      adjunct to their foot or ankle tendon revision; NeoPatch will be wrapped around the tendon&#xD;
      immediately prior to closure. The study will be divided into two phases: Screening and&#xD;
      Follow-up. The study will include prospective patient evaluations at scheduled clinic visits&#xD;
      and ultrasound appointments for a maximum of 12 visits over 12 months. Patient history,&#xD;
      medications, self-reported pain, tendon status, and adverse events will be collected on all&#xD;
      patients consented and enrolled into the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quantitative ultrasound assessment of post-operative adhesions</measure>
    <time_frame>Up to 3 weeks, post-op</time_frame>
    <description>Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative ultrasound assessment of post-operative adhesions</measure>
    <time_frame>Up to 9 weeks, post-op</time_frame>
    <description>Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative ultrasound assessment of post-operative adhesions</measure>
    <time_frame>Up to 15 weeks, post-op</time_frame>
    <description>Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative ultrasound assessment of post-operative adhesions</measure>
    <time_frame>Up to 52 weeks, post-op</time_frame>
    <description>Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quantitative ultrasound assessment of post-operative adhesions</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Average percent change in physical measurement of target tendon adhesions, by ultrasound assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative ultrasound assessment of post-operative adhesions</measure>
    <time_frame>Up to 3 weeks, post-op</time_frame>
    <description>Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative ultrasound assessment of post-operative adhesions</measure>
    <time_frame>Up to 9 weeks, post-op</time_frame>
    <description>Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative ultrasound assessment of post-operative adhesions</measure>
    <time_frame>Up to 15 weeks, post-op</time_frame>
    <description>Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative ultrasound assessment of post-operative adhesions</measure>
    <time_frame>Up to 52 weeks, post-op</time_frame>
    <description>Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS Average Pain Score</measure>
    <time_frame>Up to 1 year, post-op</time_frame>
    <description>Average self-reported pain experienced on average</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS Current Pain Score</measure>
    <time_frame>Up to 1 year, post-op</time_frame>
    <description>Average self-reported pain experienced at time of assessment (current)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in VAS Average Pain Score</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Average change in self-reported average pain from baseline (screening) to last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in VAS Current Pain Score</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Average change in self-reported current pain from baseline (screening) to last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AOFAS Foot and Ankle Function Score</measure>
    <time_frame>Up to 24 weeks, post-op</time_frame>
    <description>Average AOFAS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AOFAS Foot and Ankle Function Score</measure>
    <time_frame>Up to 52 weeks, post-op</time_frame>
    <description>Average AOFAS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in AOFAS Foot and Ankle Function Score</measure>
    <time_frame>Up to 24 weeks, post-op</time_frame>
    <description>Average AOFAS score change between baseline (Screening) and Visit 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in AOFAS Foot and Ankle Function Score</measure>
    <time_frame>Up to 52 weeks, post-op</time_frame>
    <description>Average AOFAS score change between baseline (Screening) and Visit 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Analgesics</measure>
    <time_frame>Up to 52 weeks, post-op</time_frame>
    <description>Percentage of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Use of Analgesics</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Percent change of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Tendinopathy</condition>
  <condition>Tendon Tear</condition>
  <condition>Tendon Injuries</condition>
  <condition>Foot Ankle Injuries</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NeoPatch</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NeoPatch</intervention_name>
    <description>NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic tendinopathy requiring surgical revision in the opinion of the Investigator as&#xD;
             defined in Appendix G.&#xD;
&#xD;
          -  Intention to schedule surgical revision.&#xD;
&#xD;
             ≥ 18 years.&#xD;
&#xD;
          -  Free from clinical signs of infection at time of screening and at time of surgical&#xD;
             intervention.&#xD;
&#xD;
          -  Target tendon is one of the following: Achilles, Extensor Digitorum Longus, Extensor&#xD;
             Hallucis Brevis, Extensor Hallucis Longus, Flexor Digitorum Longus, Flexor Hallucis&#xD;
             Longus, Tibialis Anterior, Tibialis Posterior, Peroneus Longus, Peroneus Brevis,&#xD;
             Peroneus Tertius.&#xD;
&#xD;
          -  Able and willing to provide consent and comply with protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of surgical intervention involving target tendon.&#xD;
&#xD;
          -  Tendon injury is acute in nature.&#xD;
&#xD;
          -  Current participation in another clinical study.&#xD;
&#xD;
          -  Currently receiving radiation or chemotherapy.&#xD;
&#xD;
          -  Diagnosis of autoimmune connective tissue disease requiring systemic immunomodulatory&#xD;
             therapy; stable NSAID doses for mild rheumatoid arthritis permitted.&#xD;
&#xD;
          -  Use of biomedical growth factor within previous 30 days.&#xD;
&#xD;
          -  Pregnant or breastfeeding or planning on becoming pregnant or unwilling to use&#xD;
             medically acceptable methods of birth control.&#xD;
&#xD;
          -  Taking medications considered to be immune system modulators within previous 30 days.&#xD;
&#xD;
          -  Patient taking specific Cox-2 inhibitors within previous 30 days.&#xD;
&#xD;
          -  Currently being treated with an investigational device or drug (within 3 months prior&#xD;
             to surgery).&#xD;
&#xD;
          -  Allergy, intolerance or hypersensitivity to any components or packaging of the&#xD;
             product.&#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>Douglas Pacaccio, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Advanced Foot and Ankle Surgeons</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advanced Foot and Ankle Surgeons</name>
      <address>
        <city>Sycamore</city>
        <state>Illinois</state>
        <zip>60178</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>May 23, 2019</last_update_submitted>
  <last_update_submitted_qc>May 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2019</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>Tendinopathy</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Ankle Injuries</mesh_term>
    <mesh_term>Tendon Injuries</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/NCT03307499
org study id: HPM1701.000-M
nct id: NCT03307499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, single center, postmarket study to evaluate the safety and
      effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair
      surgery.
This study is a prospective, single center, postmarket study to evaluate the safety and
      effectiveness of NeoPatch used as a tissue cover for chronically injured tendons requiring
      surgical revision. NeoPatch is a tissue covering derived from terminally sterilized,
      dehydrated human placental membrane tissue comprised of both amnion and chorion. Candidates
      for this study are patients presenting with chronic tendon pain that are being evaluated for
      primary tendon revision surgery following failure of standard of care or immediate need for
      surgery, as determined by the investigator. Consented patients will receive NeoPatch as an
      adjunct to their foot or ankle tendon revision; NeoPatch will be wrapped around the tendon
      immediately prior to closure. The study will be divided into two phases: Screening and
      Follow-up. The study will include prospective patient evaluations at scheduled clinic visits
      and ultrasound appointments for a maximum of 12 visits over 12 months. Patient history,
      medications, self-reported pain, tendon status, and adverse events will be collected on all
      patients consented and enrolled into the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Quantitative ultrasound assessment of post-operative adhesions
time frame: Up to 3 weeks, post-op
description: Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
measure: Quantitative ultrasound assessment of post-operative adhesions
time frame: Up to 9 weeks, post-op
description: Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
measure: Quantitative ultrasound assessment of post-operative adhesions
time frame: Up to 15 weeks, post-op
description: Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
measure: Quantitative ultrasound assessment of post-operative adhesions
time frame: Up to 52 weeks, post-op
description: Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
measure: Change in quantitative ultrasound assessment of post-operative adhesions
time frame: Through study completion, an average of 1 year
description: Average percent change in physical measurement of target tendon adhesions, by ultrasound assessment.
measure: Qualitative ultrasound assessment of post-operative adhesions
time frame: Up to 3 weeks, post-op
description: Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
measure: Qualitative ultrasound assessment of post-operative adhesions
time frame: Up to 9 weeks, post-op
description: Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
measure: Qualitative ultrasound assessment of post-operative adhesions
time frame: Up to 15 weeks, post-op
description: Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
measure: Qualitative ultrasound assessment of post-operative adhesions
time frame: Up to 52 weeks, post-op
description: Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
measure: VAS Average Pain Score
time frame: Up to 1 year, post-op
description: Average self-reported pain experienced on average
measure: VAS Current Pain Score
time frame: Up to 1 year, post-op
description: Average self-reported pain experienced at time of assessment (current)
measure: Change in VAS Average Pain Score
time frame: Through study completion, an average of 1 year
description: Average change in self-reported average pain from baseline (screening) to last follow-up visit.
measure: Change in VAS Current Pain Score
time frame: Through study completion, an average of 1 year
description: Average change in self-reported current pain from baseline (screening) to last follow-up visit.
measure: AOFAS Foot and Ankle Function Score
time frame: Up to 24 weeks, post-op
description: Average AOFAS score
measure: AOFAS Foot and Ankle Function Score
time frame: Up to 52 weeks, post-op
description: Average AOFAS score
measure: Change in AOFAS Foot and Ankle Function Score
time frame: Up to 24 weeks, post-op
description: Average AOFAS score change between baseline (Screening) and Visit 7
measure: Change in AOFAS Foot and Ankle Function Score
time frame: Up to 52 weeks, post-op
description: Average AOFAS score change between baseline (Screening) and Visit 8
measure: Use of Analgesics
time frame: Up to 52 weeks, post-op
description: Percentage of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
measure: Change in the Use of Analgesics
time frame: Through study completion, an average of 1 year
description: Percent change of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
arm group label: Treatment
arm group type: Experimental
description: NeoPatch
intervention type: Other
intervention name: NeoPatch
description: NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas Pacaccio, DPM
role: Principal Investigator
affiliation: Advanced Foot and Ankle Surgeons
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tendinopathy
mesh term: Wounds and Injuries
mesh term: Ankle Injuries
mesh term: Tendon Injuries