<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/NCT03293719</url>
  </required_header>
  <id_info>
    <org_study_id>2017-02-BPK-S Comparison</org_study_id>
    <nct_id>NCT03293719</nct_id>
  </id_info>
  <brief_title>Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic</brief_title>
  <official_title>Prospective, Open, Non-randomized, Non-interventional Explorative, Comparative, Uncontrolled Cohort Study for Post Market Clinical Follow-Up of the &quot;BPK-S Integration&quot; UC in the Variants CoCr or Ceramic as Primary Implant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peter Brehm GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>P.R.I.S.M.A.-CRO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peter Brehm GmbH</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the&#xD;
      European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in&#xD;
      either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for&#xD;
      5 years after implantation or until revision of the prosthesis, whichever occurs first.&#xD;
      Demographic data will be collected together with data regarding safety and benefit at defined&#xD;
      timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after&#xD;
      implantation).&#xD;
&#xD;
      Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Monocentric Study, Site reorganised, could no longer participate in study&#xD;
  </why_stopped>
  <start_date type="Actual">March 20, 2018</start_date>
  <completion_date type="Actual">October 14, 2019</completion_date>
  <primary_completion_date type="Actual">October 14, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient relevant benefit after 5 years</measure>
    <time_frame>5 years</time_frame>
    <description>improvement of KSS-Score by at least one category as compared to preoperative basic assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient relevant benefit as measured by American Knee Society Score</measure>
    <time_frame>3 months, 1, 2 and 5 years</time_frame>
    <description>improvement of KSS-Score as compared to preoperative basic assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score</measure>
    <time_frame>3 months, 1, 2 and 5 years</time_frame>
    <description>Improvement of KOOS as compared to preoperative basic assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Quality of Life</measure>
    <time_frame>3 months, 1, 2 and 5 years</time_frame>
    <description>Improvement of EQ-5D as compared to preoperative basic assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant Loosening Number</measure>
    <time_frame>3 months, 1, 2 and 5 years</time_frame>
    <description>Number of implant loosening due to quality issues with the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant Loosening Reason</measure>
    <time_frame>3 months, 1, 2 and 5 years</time_frame>
    <description>Reason for implant loosening due to quality issues with the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revision Number</measure>
    <time_frame>3 months, 1, 2 and 5 years</time_frame>
    <description>Number of revisions, if required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revision Reason</measure>
    <time_frame>3 months, 1, 2 and 5 years</time_frame>
    <description>Reason for revision, if required</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Joint Instability</condition>
  <condition>Arthritis</condition>
  <condition>Joint Disease</condition>
  <condition>Musculoskeletal Disease</condition>
  <condition>Rheumatic Diseases</condition>
  <arm_group>
    <arm_group_label>Ceramic</arm_group_label>
    <description>Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CoCr</arm_group_label>
    <description>Patients receiving BPK-S Integration UC implant made from CoCr (metal)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BPK-S Integration UC</intervention_name>
    <description>Primary Knee Endoprosthesis</description>
    <arm_group_label>Ceramic</arm_group_label>
    <arm_group_label>CoCr</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing primary total knee endoprosthesis with BPK-S Integration of age 18 and&#xD;
        older&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Congenital or acquired knee joint defects/deformation&#xD;
&#xD;
          -  Defects or malfunction of the knee joint&#xD;
&#xD;
          -  Arthrosis (degenerative, rheumatic)&#xD;
&#xD;
          -  Post-traumatic arthritis&#xD;
&#xD;
          -  Symptomatic knee instability&#xD;
&#xD;
          -  Reconstruction of flexibility&#xD;
&#xD;
          -  Patients with metal hypersensitivity (ceramic tibia/femur)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Illnesses which can be treated without using a knee joint implant.&#xD;
&#xD;
          -  Acute or chronic infections near the implantation&#xD;
&#xD;
          -  Systemic diseases and metabolic disorders&#xD;
&#xD;
          -  Serious osteoporosis&#xD;
&#xD;
          -  Serious damage to the bone structures that impedes stable implantation of the implant&#xD;
             components&#xD;
&#xD;
          -  Diseases that impair bone growth, e.g. cancer, renal dialysis, osteopenia, etc.&#xD;
&#xD;
          -  Bone tumors in the area of the implant anchoring&#xD;
&#xD;
          -  Obesity or overweight of the patient&#xD;
&#xD;
          -  Overload of the knee implant to be expected&#xD;
&#xD;
          -  Abuse of medication, drug abuse, alcoholism or mental disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lack of patient cooperation&#xD;
&#xD;
          -  Sensitivity to foreign matter in the implant materials&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Patients participating in another trial&#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>Christian E. Berger, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sozialmedizinisches Zentrum Ost - Donauspital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SMZ Ost, Donauspital</name>
      <address>
        <city>Vienna</city>
        <state>Oberösterreich</state>
        <zip>1220</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 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>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Joint Instability</mesh_term>
    <mesh_term>Collagen Diseases</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/NCT03293719
org study id: 2017-02-BPK-S Comparison
nct id: NCT03293719
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the
      European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in
      either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for
      5 years after implantation or until revision of the prosthesis, whichever occurs first.
      Demographic data will be collected together with data regarding safety and benefit at defined
      timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after
      implantation).

      Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.
observational model: Cohort
time perspective: Prospective
measure: Patient relevant benefit after 5 years
time frame: 5 years
description: improvement of KSS-Score by at least one category as compared to preoperative basic assessment
measure: Patient relevant benefit as measured by American Knee Society Score
time frame: 3 months, 1, 2 and 5 years
description: improvement of KSS-Score as compared to preoperative basic assessment
measure: Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score
time frame: 3 months, 1, 2 and 5 years
description: Improvement of KOOS as compared to preoperative basic assessment
measure: Patient Quality of Life
time frame: 3 months, 1, 2 and 5 years
description: Improvement of EQ-5D as compared to preoperative basic assessment
measure: Implant Loosening Number
time frame: 3 months, 1, 2 and 5 years
description: Number of implant loosening due to quality issues with the implant
measure: Implant Loosening Reason
time frame: 3 months, 1, 2 and 5 years
description: Reason for implant loosening due to quality issues with the implant
measure: Revision Number
time frame: 3 months, 1, 2 and 5 years
description: Number of revisions, if required
measure: Revision Reason
time frame: 3 months, 1, 2 and 5 years
description: Reason for revision, if required
arm group label: Ceramic
description: Patients receiving BPK-S Integration UC implant made from BIOLOX delta ceramic
arm group label: CoCr
description: Patients receiving BPK-S Integration UC implant made from CoCr (metal)
intervention type: Device
intervention name: BPK-S Integration UC
description: Primary Knee Endoprosthesis
arm group label: Ceramic
arm group label: CoCr
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian E. Berger, Prof.
role: Principal Investigator
affiliation: Sozialmedizinisches Zentrum Ost - Donauspital
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Rheumatic Diseases
mesh term: Joint Diseases
mesh term: Musculoskeletal Diseases
mesh term: Joint Instability
mesh term: Collagen Diseases