xml: <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/NCT05998785</url>
    </required_header>
    <id_info>
      <org_study_id>EMBODY-002</org_study_id>
      <nct_id>NCT05998785</nct_id>
    </id_info>
    <brief_title>Embody Insertional Achilles Tendinopathy</brief_title>
    <acronym>IAT</acronym>
    <official_title>A Multi-Center, Prospective Case Series Evaluating Insertional Achilles Tendinopathy Repair Augmented With TAPESTRY® Biointegrative Implant</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zimmer Biomet</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Embody Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Zimmer Biomet</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 primary objective of this study is to evaluate the long-term effects on ankle/Achilles&#xD;
        tendon pain after repair of insertional Achilles tendinopathy (IAT) augmented with TAPESTRY&#xD;
        Biointegrative Implant.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective case series of patients who have had insertional Achilles&#xD;
        tendinopathy repair augmented with the Tapestry Biointegrative Implant. The primary aim of&#xD;
        the study is to describe patient reported pain 12 months after surgical repair with Tapestry.&#xD;
        The secondary aims are to assess the proportion of study subjects that experience&#xD;
        treatment-related adverse events post-surgery, treatment related serious adverse events&#xD;
        resulting in second surgical intervention, quality of life and other patient reported&#xD;
        outcomes at all follow up timepoints post-surgery, and tissue thickness measured with MRI at&#xD;
        6 months post-surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 2, 2022</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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/VAS</measure>
      <time_frame>12 months post-surgery</time_frame>
      <description>Visual Analog Scale (VAS) survey</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety/Adverse Events</measure>
      <time_frame>Surgery, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op</time_frame>
      <description>Procedure and/or treatment related adverse events;&#xD;
  Procedure and/or treatment related Serious Adverse Events (SAE)&#xD;
  Procedure and/or treatment related Serious Adverse Events (SAE) necessitating a second surgical intervention (SSI);</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction</measure>
      <time_frame>1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op</time_frame>
      <description>Patient Satisfaction Survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to Normal Activity</measure>
      <time_frame>1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op</time_frame>
      <description>Return to Normal Activity survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AOFAS</measure>
      <time_frame>Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op</time_frame>
      <description>American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SF-12</measure>
      <time_frame>Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op</time_frame>
      <description>12-item Short Form- Health Survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tissue Thickness</measure>
      <time_frame>Baseline and 6 months post-op</time_frame>
      <description>MRI tissue thickness of the Achilles tendon at baseline and 6 months post-surgery. Tissue thickness will be measured by trained personnel per the EMBODY-002 MRI procedure manual.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Insertional Achilles Tendinopathy</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>TAPESTRY Biointegrative Implant</intervention_name>
      <description>Collagen-based implant composed of type I bovine collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Preclinical studies of the Tapestry implant showed dense collagenous fibrous connective tissue ingrowth into and around the implant.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Enrolled subjects will include adults with insertional Achilles tendonitis requiring&#xD;
          surgery, who meet the study eligibility criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult, 21 years and older;&#xD;
  &#xD;
            -  Insertional Achilles tendonitis requiring surgery that has failed at least 2 weeks of&#xD;
               conservative management, which consist of:&#xD;
  &#xD;
                 1. Shoe modification; or&#xD;
  &#xD;
                 2. Nonsteroidal anti-inflammatory drugs; or&#xD;
  &#xD;
                 3. Physical Therapy with/without modalities.&#xD;
  &#xD;
            -  Chronic Achilles tendon pain lasting longer than 3 months;&#xD;
  &#xD;
            -  MRI of the ankle within 30 days prior to the study surgery;&#xD;
  &#xD;
            -  Ability and willingness to comply with prescribed post-operative rehabilitation&#xD;
               program;&#xD;
  &#xD;
            -  Ability and willingness to comply with follow-up regimen;&#xD;
  &#xD;
            -  Able to understand the informed consent process, including regulatory requirements&#xD;
               such as HIPAA authorization, and document informed consent prior to completion of any&#xD;
               study-related procedures; and&#xD;
  &#xD;
            -  Ability to read, understand, and complete subject-reported outcomes in English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of Achilles tendon rupture;&#xD;
  &#xD;
            -  Previous Achilles tendon surgery on the index ankle;&#xD;
  &#xD;
            -  Genetic collagen disease, hypersensitivity, or objection to using bovine-derived&#xD;
               materials;&#xD;
  &#xD;
            -  History of auto-immune or immunodeficiency disorders;&#xD;
  &#xD;
            -  History of chronic inflammatory disorders;&#xD;
  &#xD;
            -  Oral steroid use in last 2 months or injectable steroid use in last 4 weeks;&#xD;
  &#xD;
            -  History of heavy smoking (&gt; 1 pack per day) within last 6 months;&#xD;
  &#xD;
            -  Hypersensitivity to poly(D,L-lactide) materials;&#xD;
  &#xD;
            -  Metal implants, fillings, shrapnel, and/or screws;&#xD;
  &#xD;
            -  Females of child-bearing potential who are pregnant or plan to become pregnant during&#xD;
               the course of the study;&#xD;
  &#xD;
            -  Currently involved in any injury litigation or worker's compensation claims relating&#xD;
               to the index ankle;&#xD;
  &#xD;
            -  Enrolled, or plans to enroll, in another clinical trial during this studythat would&#xD;
               affect the outcomes of this study; or&#xD;
  &#xD;
            -  History of non-compliance with medical treatment, physical therapy/rehabilitation, or&#xD;
               clinical study participation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Weil Foot and Ankle Institute</name>
        <address>
          <city>Libertyville</city>
          <state>Illinois</state>
          <zip>60048</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Utica Park Clinic</name>
        <address>
          <city>Tulsa</city>
          <state>Oklahoma</state>
          <zip>74104</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>Tendinopathy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05998785
  org study id: EMBODY-002
  nct id: NCT05998785
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The primary objective of this study is to evaluate the long-term effects on ankle/Achilles
        tendon pain after repair of insertional Achilles tendinopathy (IAT) augmented with TAPESTRY
        Biointegrative Implant.
  This study is a prospective case series of patients who have had insertional Achilles
        tendinopathy repair augmented with the Tapestry Biointegrative Implant. The primary aim of
        the study is to describe patient reported pain 12 months after surgical repair with Tapestry.
        The secondary aims are to assess the proportion of study subjects that experience
        treatment-related adverse events post-surgery, treatment related serious adverse events
        resulting in second surgical intervention, quality of life and other patient reported
        outcomes at all follow up timepoints post-surgery, and tissue thickness measured with MRI at
        6 months post-surgery.
  observational model: Case-Only
  time perspective: Prospective
  measure: Pain/VAS
  time frame: 12 months post-surgery
  description: Visual Analog Scale (VAS) survey
  measure: Safety/Adverse Events
  time frame: Surgery, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
  description: Procedure and/or treatment related adverse events;
  Procedure and/or treatment related Serious Adverse Events (SAE)
  Procedure and/or treatment related Serious Adverse Events (SAE) necessitating a second surgical intervention (SSI);
  measure: Patient Satisfaction
  time frame: 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
  description: Patient Satisfaction Survey
  measure: Return to Normal Activity
  time frame: 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
  description: Return to Normal Activity survey
  measure: AOFAS
  time frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
  description: American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot questionnaire
  measure: SF-12
  time frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
  description: 12-item Short Form- Health Survey
  measure: Tissue Thickness
  time frame: Baseline and 6 months post-op
  description: MRI tissue thickness of the Achilles tendon at baseline and 6 months post-surgery. Tissue thickness will be measured by trained personnel per the EMBODY-002 MRI procedure manual.
  intervention type: Device
  intervention name: TAPESTRY Biointegrative Implant
  description: Collagen-based implant composed of type I bovine collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Preclinical studies of the Tapestry implant showed dense collagenous fibrous connective tissue ingrowth into and around the implant.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Tendinopathy
  sharing ipd: No