<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/NCT03808623</url>
  </required_header>
  <id_info>
    <org_study_id>AAG-O-H-1712</org_study_id>
    <nct_id>NCT03808623</nct_id>
  </id_info>
  <brief_title>Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MAC</brief_title>
  <acronym>NBasic</acronym>
  <official_title>Non-interventional Study to Evaluate the Safety and Performance of NOVOCART® Basic and the Clinical Outcome of MAC With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tetec AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aesculap AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Winicker Norimed GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tetec 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>
      Retrospective, multicenter, single arm, non-interventional study to assess the safety and&#xD;
      Performance of NOVOCART Basic and the clinical outcome of MAC with NOVOCART Basic in patients&#xD;
      treated for cartilage defects in the knee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multi-center, single arm, non-interventional study to assess the safety and&#xD;
      performance of NOVOCART® Basic and the clinical outcome of MAC with NOVOCART® Basic in&#xD;
      patients treated for cartilage defects in the knee. In this study data will be collected&#xD;
      retrospectively from patient files of adult and pediatric patients who had received an MAC&#xD;
      with NOVOCART® Basic for cartilage defects in the knee according to medical practice. In&#xD;
      addition, at the time when a patient consents to participate in the study, he/she will have&#xD;
      to fill-out questionnaires on current symptoms and knee function, quality of life,&#xD;
      satisfaction with treatment and subsequent surgical interventions on the target knee&#xD;
      performed outside the study site, i.e. the duration of follow-up is not standardized. All&#xD;
      clinical sites having treated more than 8 patients with NOVOCART® Basic between 2014 and 2017&#xD;
      will be contacted for participation. Participating clinical sites will be asked to collect&#xD;
      informed consent from their patients to document relevant data from their medical charts and&#xD;
      to complete the questionnaires. Consenting patients will send the signed informed consent&#xD;
      form(s) and the completed questionnaires back to the study site. The date of questionnaire&#xD;
      completion is regarded the end of observation for an individual patient. For data&#xD;
      documentation, a medical documentation specialist authorized by TETEC AG will be given access&#xD;
      to the patient files, the informed consent forms, and the completed questionnaires. The&#xD;
      relevant data will be entered directly into an electronic database by the medical&#xD;
      documentation specialist. Only data from patients who have given informed consent to study&#xD;
      participation will be documented. If available, post-MAC MRIs will be collected and reviewed&#xD;
      by independent experts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2018</start_date>
  <completion_date type="Actual">July 24, 2019</completion_date>
  <primary_completion_date type="Actual">July 24, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the safety of NOVOCART® Basic</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Number of participants with treatment related adverse device effects or adverse events related to the procedure involved</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of therapy change</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Rate of therapy change (other surgical cartilage repair modality applied to the MAC treated defect(s))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse device effects</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Number of treatment related adverse device effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of device deficiencies</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Number of device deficiencies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events related to the procedure involved</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Number of adverse events related to the procedure involved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KOOS</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Questionnaire: Knee injury and Osteoarthrisits Outcome Score (KOOS)(KOOS5 and subscores)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IKDC</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Questionnaire: International Knee Documentation Committee (IKDC2000) subjective score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Quality of life (EQ-5D-5L index)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with treatment</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>5 questions to patient satisfaction with treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI if available</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score will be used for assessment of the in vivo performance, if post-MAC MRIs are available from clinical routine</description>
  </secondary_outcome>
  <enrollment type="Actual">41</enrollment>
  <condition>Cartilage Diseases</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MAC with NOVOCART Basic</intervention_name>
    <description>NOVOCART® Basic is a biphasic, collagen-based matrix to support the biological reconstruction of localized and full-thickness cartilage damages after treatment with bone marrow stimulation techniques (microfracture). The procedure is called matrix associated chondrogenesis (MAC). It is a single-step procedure.&#xD;
NOVOCART® Basic is tailored to fit the prepared defect size and is inserted in the defect area after microfracture. The NOVOCART® Basic device component is fully resorbed over a period of a few months as new reparative cartilage tissue is generated and integrated with the surrounding host tissue.</description>
    <other_name>MAC</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients (adult and pediatric) who have received an MAC with NOVOCART® Basic in the&#xD;
        knee are eligible for this study, provided that they have given their informed consent for&#xD;
        data collection and the involved clinical site has agreed to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  for the biological reconstruction of localized full-layer cartilage damage (III and IV&#xD;
             degree defects pursuant to the ICRS classification) in the knee joint.&#xD;
&#xD;
          -  Treatable defects include:&#xD;
&#xD;
          -  Cartilage damage caused by trauma&#xD;
&#xD;
          -  Defects due to osteochondrosis dissecans&#xD;
&#xD;
          -  Smaller focally-limited, degenerative cartilage damage&#xD;
&#xD;
          -  Patients aged between 18 and 55 years&#xD;
&#xD;
          -  Cartilage defect sizes from 1.5 to 4 cm²&#xD;
&#xD;
          -  Deep osseous substance defects require prior osseous reconstruction. The indication&#xD;
             should be confirmed using arthroscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known allergies to bovine collagen.&#xD;
&#xD;
          -  Infected joints or infected wounds/areas near the joint, arthritis or inflammatory&#xD;
             joint diseases of any type are contraindicated.&#xD;
&#xD;
          -  More than two corresponding cartilage defects&#xD;
&#xD;
          -  Instability of the knee, subtotal/total meniscus resection&#xD;
&#xD;
          -  Varus/valgus malpositions (corrective surgery required in such cases)&#xD;
&#xD;
          -  Haemorrhagic diathesis of various origins&#xD;
&#xD;
          -  Applications which are not listed in the Indications section.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Bernhard Waibl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cartilage Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Theresienkrankenhaus und St. Hedwig-Klinik GmbH</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Württemberg</state>
        <zip>68165</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxisklinik Rennbahn AG</name>
      <address>
        <city>Muttenz</city>
        <state>Cantone Of Basel-Landschaft</state>
        <zip>4132</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cartilage Care</name>
      <address>
        <city>Bern</city>
        <state>Cantone Of Bern</state>
        <zip>3012</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>March 31, 2020</last_update_submitted>
  <last_update_submitted_qc>March 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cartilage defect</keyword>
  <keyword>knee</keyword>
  <keyword>MAC (Matrix associated chondrogenesis)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cartilage 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/NCT03808623
org study id: AAG-O-H-1712
nct id: NCT03808623
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective, multicenter, single arm, non-interventional study to assess the safety and
      Performance of NOVOCART Basic and the clinical outcome of MAC with NOVOCART Basic in patients
      treated for cartilage defects in the knee.
This study is a multi-center, single arm, non-interventional study to assess the safety and
      performance of NOVOCART® Basic and the clinical outcome of MAC with NOVOCART® Basic in
      patients treated for cartilage defects in the knee. In this study data will be collected
      retrospectively from patient files of adult and pediatric patients who had received an MAC
      with NOVOCART® Basic for cartilage defects in the knee according to medical practice. In
      addition, at the time when a patient consents to participate in the study, he/she will have
      to fill-out questionnaires on current symptoms and knee function, quality of life,
      satisfaction with treatment and subsequent surgical interventions on the target knee
      performed outside the study site, i.e. the duration of follow-up is not standardized. All
      clinical sites having treated more than 8 patients with NOVOCART® Basic between 2014 and 2017
      will be contacted for participation. Participating clinical sites will be asked to collect
      informed consent from their patients to document relevant data from their medical charts and
      to complete the questionnaires. Consenting patients will send the signed informed consent
      form(s) and the completed questionnaires back to the study site. The date of questionnaire
      completion is regarded the end of observation for an individual patient. For data
      documentation, a medical documentation specialist authorized by TETEC AG will be given access
      to the patient files, the informed consent forms, and the completed questionnaires. The
      relevant data will be entered directly into an electronic database by the medical
      documentation specialist. Only data from patients who have given informed consent to study
      participation will be documented. If available, post-MAC MRIs will be collected and reviewed
      by independent experts.
observational model: Case-Only
time perspective: Retrospective
measure: Assessment of the safety of NOVOCART® Basic
time frame: Up to 5 years
description: Number of participants with treatment related adverse device effects or adverse events related to the procedure involved
measure: Rate of therapy change
time frame: Up to 5 years
description: Rate of therapy change (other surgical cartilage repair modality applied to the MAC treated defect(s))
measure: Rate of adverse device effects
time frame: Up to 5 years
description: Number of treatment related adverse device effects
measure: Rate of device deficiencies
time frame: Up to 5 years
description: Number of device deficiencies
measure: Rate of adverse events related to the procedure involved
time frame: Up to 5 years
description: Number of adverse events related to the procedure involved
measure: KOOS
time frame: Up to 5 years
description: Questionnaire: Knee injury and Osteoarthrisits Outcome Score (KOOS)(KOOS5 and subscores)
measure: IKDC
time frame: Up to 5 years
description: Questionnaire: International Knee Documentation Committee (IKDC2000) subjective score
measure: EQ-5D-5L
time frame: Up to 5 years
description: Quality of life (EQ-5D-5L index)
measure: Patient satisfaction with treatment
time frame: Up to 5 years
description: 5 questions to patient satisfaction with treatment
measure: MRI if available
time frame: Up to 5 years
description: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score will be used for assessment of the in vivo performance, if post-MAC MRIs are available from clinical routine
intervention type: Device
intervention name: MAC with NOVOCART Basic
description: NOVOCART® Basic is a biphasic, collagen-based matrix to support the biological reconstruction of localized and full-thickness cartilage damages after treatment with bone marrow stimulation techniques (microfracture). The procedure is called matrix associated chondrogenesis (MAC). It is a single-step procedure.
NOVOCART® Basic is tailored to fit the prepared defect size and is inserted in the defect area after microfracture. The NOVOCART® Basic device component is fully resorbed over a period of a few months as new reparative cartilage tissue is generated and integrated with the surrounding host tissue.
other name: MAC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
last name: Bernhard Waibl, MD
role: Principal Investigator
affiliation: Cartilage Care
facility: 
facility: 
facility: 
country: Germany
country: Switzerland
responsible party type: Sponsor
mesh term: Cartilage Diseases