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/NCT06028971</url>
    </required_header>
    <id_info>
      <org_study_id>1156</org_study_id>
      <nct_id>NCT06028971</nct_id>
    </id_info>
    <brief_title>Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series</brief_title>
    <official_title>Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>41medical AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>AO Innovation Translation Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>41medical AG</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>
        The goal of this observational multicenter case series is to assess the safety and&#xD;
        performance of the CE-marked &quot;Biphasic Plate Distal Femur&quot; during standard of care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this observational study is to assess the safety and performance of the CE-marked&#xD;
        &quot;Biphasic Plate Distal Femur&quot; during standard of care. The study is conducted as a&#xD;
        retrospective and prospective multicenter case series. Eligible patients are those with&#xD;
        fractures of the distal femur who are treated with the Biphasic Plate DF according to the&#xD;
        Instruction for Use (IFU). The patient will be followed-up until healing or up to 12 months,&#xD;
        whichever comes first.&#xD;
  &#xD;
        To assess the safety and performance following data is collected:&#xD;
  &#xD;
          -  incidents of AEs/SAEs occurring in the affected lower extremity/extremities&#xD;
  &#xD;
          -  Bone healing assessed by a surgeon&#xD;
  &#xD;
          -  Weightbearing and function&#xD;
  &#xD;
          -  Patients' quality of life and pain level&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">November 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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Occurrence of AEs/SAEs in the affected lower extremity/extremities</measure>
      <time_frame>until clinically healed or up to 12 months</time_frame>
      <description>The primary outcome measure is the occurrence of AEs/SAEs in the affected lower extremity/extremities that are deemed related, probably related, or possibly related to the surgical procedure or the Biphasic Plate DF</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bone Healing</measure>
      <time_frame>until clinically healed or up to 12 months</time_frame>
      <description>Radiographic bone healing assessment using the modified Radiographic Union Scale for Tibia (mRUST) Score (1: Callus absent, visible fracture line, 2: Callus present, visible fracture line, 3: Callus bridging, visible fracture line, 4: Callus remodeled, invisible fracture line)&#xD;
  Bone healing as assessed by the surgeon</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported outcome measures</measure>
      <time_frame>until clinically healed or up to 12 months</time_frame>
      <description>Quality of life questionaire Pain NRS (0-10) upon weightbearing</description>
    </secondary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Distal Femur Fracture</condition>
    <condition>Periprosthetic Fractures</condition>
    <condition>Intra-Articular Fractures</condition>
    <condition>Supracondylar Fracture</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Eledgible patients will be identified at the sites (primary care clinics)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with fractures of the distal femur requiring internal fixation and treated&#xD;
               with the Biphasic Plate DF as indicated according to the IFU. As per the IFU, the&#xD;
               Biphasic Plate DF is indicated for:&#xD;
  &#xD;
                 -  Distal shaft fractures&#xD;
  &#xD;
                 -  Supracondylar fractures&#xD;
  &#xD;
                 -  Intraarticular fractures&#xD;
  &#xD;
                 -  Periprosthetic fractures&#xD;
  &#xD;
            -  No other major implant beside the Biphasic Plate DF is used for fixation of the distal&#xD;
               femur fracture, with the exceptions of lag screw(s) and/or cerclage wire(s), and/or a&#xD;
               joint replacement.&#xD;
  &#xD;
            -  Patients who are willing and able to comply with postoperative FUs per local standard&#xD;
               of care.&#xD;
  &#xD;
            -  Ability to provide informed consent according to the IRB/EC defined and approved&#xD;
               procedures.&#xD;
  &#xD;
            -  Patients over 18 years of age&#xD;
  &#xD;
          Exclusion Criteria (preoperatively):&#xD;
  &#xD;
            -  Patient is participating in another interventional clinical trial.&#xD;
  &#xD;
          Exclusion Criteria (intraoperatively):&#xD;
  &#xD;
            -  Change of surgical plan intraoperatively at the discretion of the surgeon that&#xD;
               Biphasic Plate DF is not used&#xD;
  &#xD;
            -  Necessity to apply a second (medial) plate (double plating) or an intramedullary nail&#xD;
               in case of critical fixation distally&#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>Christoph Sommer, Dr. med.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kantonsspital Graubünden Chur</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marcel Aeschlimann</last_name>
      <phone>+41 32 645 41 41</phone>
      <email>clinicaltrials@41medical.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ladina Hofmann</last_name>
      <phone>+41 79 600 61 98</phone>
      <email>ladina.hofmann@aofoundation.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Univeritätsklinikum Münster</name>
        <address>
          <city>Münster</city>
          <state>Nordrhein-Westfalen</state>
          <zip>48149</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Marion Laumann</last_name>
        <phone>+49 251 - 83 51479</phone>
        <email>marion.laumann@ukmuenster.de</email>
      </contact>
      <investigator>
        <last_name>Michael J. Raschke, Univ.-Prof. Dr. med.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Diakonie Jung-Stilling Siegen</name>
        <address>
          <city>Siegen</city>
          <state>Nordrhein-Westfalen</state>
          <zip>57074</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Steffen Schröter, Prof. Dr. med.</last_name>
        <phone>+492713334505</phone>
        <email>schroeter.steffen@t-online.de</email>
      </contact>
      <investigator>
        <last_name>Steffen Schröter, Prof. Dr. med.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Thorsten Knott, Dr. med.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Kantonsspital Graubünden</name>
        <address>
          <city>Chur</city>
          <state>Graubünden</state>
          <zip>7000</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Christoph Sommer, Dr. med.</last_name>
        <phone>+41812566111</phone>
        <email>Christoph.Sommer@ksgr.ch</email>
      </contact>
      <investigator>
        <last_name>Christoph Sommer, Dr. med.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Universitätsspital Zürich</name>
        <address>
          <city>Zürich</city>
          <zip>8091</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Sandro-Michael Heining, Dr. med.</last_name>
        <phone>+41 44 255 23 99</phone>
        <email>sandro.heining@usz.ch</email>
      </contact>
      <investigator>
        <last_name>Sandro-Michael Heining, Dr. med.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Biphasic Plate DF</keyword>
    <keyword>Distal Femur Fracture</keyword>
    <keyword>Femur Fracture</keyword>
    <keyword>Periprosthetic Fractures</keyword>
    <keyword>Intra-Articular Fractures</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Femoral Fractures</mesh_term>
      <mesh_term>Femoral Fractures, Distal</mesh_term>
      <mesh_term>Intra-Articular Fractures</mesh_term>
      <mesh_term>Periprosthetic Fractures</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/NCT06028971
  org study id: 1156
  nct id: NCT06028971
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational multicenter case series is to assess the safety and
        performance of the CE-marked "Biphasic Plate Distal Femur" during standard of care.
  The goal of this observational study is to assess the safety and performance of the CE-marked
        "Biphasic Plate Distal Femur" during standard of care. The study is conducted as a
        retrospective and prospective multicenter case series. Eligible patients are those with
        fractures of the distal femur who are treated with the Biphasic Plate DF according to the
        Instruction for Use (IFU). The patient will be followed-up until healing or up to 12 months,
        whichever comes first.
  
        To assess the safety and performance following data is collected:
  
          -  incidents of AEs/SAEs occurring in the affected lower extremity/extremities
  
          -  Bone healing assessed by a surgeon
  
          -  Weightbearing and function
  
          -  Patients' quality of life and pain level
  observational model: Case-Only
  time perspective: Other
  measure: Occurrence of AEs/SAEs in the affected lower extremity/extremities
  time frame: until clinically healed or up to 12 months
  description: The primary outcome measure is the occurrence of AEs/SAEs in the affected lower extremity/extremities that are deemed related, probably related, or possibly related to the surgical procedure or the Biphasic Plate DF
  measure: Bone Healing
  time frame: until clinically healed or up to 12 months
  description: Radiographic bone healing assessment using the modified Radiographic Union Scale for Tibia (mRUST) Score (1: Callus absent, visible fracture line, 2: Callus present, visible fracture line, 3: Callus bridging, visible fracture line, 4: Callus remodeled, invisible fracture line)
  Bone healing as assessed by the surgeon
  measure: Patient-reported outcome measures
  time frame: until clinically healed or up to 12 months
  description: Quality of life questionaire Pain NRS (0-10) upon weightbearing
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christoph Sommer, Dr. med.
  role: Principal Investigator
  affiliation: Kantonsspital Graubünden Chur
  last name: Marcel Aeschlimann
  phone: +41 32 645 41 41
  email: clinicaltrials@41medical.com
  last name: Ladina Hofmann
  phone: +41 79 600 61 98
  email: ladina.hofmann@aofoundation.org
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: Germany
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Fractures, Bone
  mesh term: Femoral Fractures
  mesh term: Femoral Fractures, Distal
  mesh term: Intra-Articular Fractures
  mesh term: Periprosthetic Fractures
  sharing ipd: No