<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/NCT03755388</url>
  </required_header>
  <id_info>
    <org_study_id>S61896</org_study_id>
    <nct_id>NCT03755388</nct_id>
  </id_info>
  <brief_title>Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant</brief_title>
  <official_title>Long-term Prospective Interventional Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant - Episealer 2 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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 study is to evaluate the efficacy, safety and performance of the Episealer®&#xD;
      device in a sample size of 30 patients and on the long term (10 years follow-up).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lesions in the cartilage are common disorders. In the knee, cartilage lesions are found in&#xD;
      over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority&#xD;
      are found in the medial femoral condyle. The quality of life of patients with focal cartilage&#xD;
      defects is significantly affected and it has been shown that the quality of life is affected&#xD;
      to the same extend as in patients scheduled for knee replacement. Arthroscopy lavage and&#xD;
      debridement micro fracturing, mosaic plasticity as well as osteochondral autograft&#xD;
      transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help&#xD;
      the patients but there is an ongoing treatment gap especially for patients with knee lesions&#xD;
      and early osteoarthritis.&#xD;
&#xD;
      Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant.&#xD;
      The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral&#xD;
      condyle in order to alleviate pain and improve range of motion. The implant and surgical&#xD;
      instruments are customized to each patient's joint anatomy, position, and size of injury,&#xD;
      based on patient-specific images (MRI). The Episealer® device is CE marked.&#xD;
&#xD;
      The Episealer® implant consists of a peg and a hat. The implant exists in five different&#xD;
      diameters (12,14,17, 20 and 25mm), depending on the lesion size. The shape of the hat is&#xD;
      circular or oval.&#xD;
&#xD;
      The Episealer® implant is made of biocompatible cobalt/chromium/molybdenum alloy. To enhance&#xD;
      the osseointegration, the implant is coated with biocompatible hydroxyapatite onto an&#xD;
      interlaying biocompatible pure titanium coating.&#xD;
&#xD;
      A previous study (S57685) showed that Episealer is a viable option for focal cartilage&#xD;
      lesions of the distal femur not responding, or not eligible for, biological treatment options&#xD;
      (eg. microfracturing). This device is a good solution when there are no alternative&#xD;
      treatments, except prosthesis surgery, available.&#xD;
&#xD;
      The goal is to evaluate the efficacy, safety and performance of the Episealer® device in a&#xD;
      larger sample size and on the long term.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 20, 2018</start_date>
  <completion_date type="Anticipated">December 2032</completion_date>
  <primary_completion_date type="Anticipated">December 2028</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>10 years</time_frame>
    <description>Presence of the implant in the patient up to 10 years post treatment with loss/revision of the primary implant as endpoint</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic measurements</measure>
    <time_frame>10 years</time_frame>
    <description>Efficacy will be evaluated with the comparison of the pre- and post- operative radiographs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>10 years</time_frame>
    <description>Performance will be evaluated with the comparison of the pre- and post- operative KOOS-scores. Scoring: each item is scored between 0 and 4 and the raw score of each section is the sum or item scores. The score is then converted into a 0-100 scale. A higher score indicates fewer problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS) pain</measure>
    <time_frame>10 years</time_frame>
    <description>Performance will be evaluated with the comparison of the pre- and post- operative VAS-scores. Score between 0 and 10. Higher score indicates more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>10 years</time_frame>
    <description>Safety will be evaluated by monitoring AEs, unanticipated device effects and subsequent interventions through 10 years post treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cartilage Damage</condition>
  <condition>Knee Injuries</condition>
  <arm_group>
    <arm_group_label>Episealer group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Episealer</intervention_name>
    <description>Placing Episealer device</description>
    <arm_group_label>Episealer group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with a focal cartilage lesion of the distal femur in which biological&#xD;
             surgical methods have failed or are not eligible&#xD;
&#xD;
          -  Minimal age 18 years (Preferred age group &gt;40 years)&#xD;
&#xD;
          -  Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set&#xD;
             by the size and location of the lesion.&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under age (&lt;18yrs)&#xD;
&#xD;
          -  Active or recent (&lt;1 yr) septic arthritis of the involved knee&#xD;
&#xD;
          -  Associated symptomatic untreated ligamentary or meniscal pathology in the involved&#xD;
             knee&#xD;
&#xD;
          -  (Severe) osteoarthritis in the involved or other compartments of the involved knee&#xD;
&#xD;
          -  Severe osteoporosis&#xD;
&#xD;
          -  MRI not possible (eg. due to pacemaker)&#xD;
&#xD;
          -  Marked valgus- or varus alignment (&gt;6 degrees)&#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>Hilde Vandenneucker, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lore Hermans, MSc</last_name>
    <phone>+32 16338818</phone>
    <email>orthopedie.research@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kristel Van de loock, MSc</last_name>
    <phone>+32 16341266</phone>
    <email>orthopedie.research@uzleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lore Hermans, MSc</last_name>
      <phone>+32 16 33 88 18</phone>
      <email>orthopedie.research@uzleuven.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 5, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</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>Knee Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>To be decided</ipd_description>
  </patient_data>
  <!-- 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/NCT03755388
org study id: S61896
nct id: NCT03755388
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to evaluate the efficacy, safety and performance of the Episealer®
      device in a sample size of 30 patients and on the long term (10 years follow-up).
Lesions in the cartilage are common disorders. In the knee, cartilage lesions are found in
      over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority
      are found in the medial femoral condyle. The quality of life of patients with focal cartilage
      defects is significantly affected and it has been shown that the quality of life is affected
      to the same extend as in patients scheduled for knee replacement. Arthroscopy lavage and
      debridement micro fracturing, mosaic plasticity as well as osteochondral autograft
      transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help
      the patients but there is an ongoing treatment gap especially for patients with knee lesions
      and early osteoarthritis.

      Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant.
      The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral
      condyle in order to alleviate pain and improve range of motion. The implant and surgical
      instruments are customized to each patient's joint anatomy, position, and size of injury,
      based on patient-specific images (MRI). The Episealer® device is CE marked.

      The Episealer® implant consists of a peg and a hat. The implant exists in five different
      diameters (12,14,17, 20 and 25mm), depending on the lesion size. The shape of the hat is
      circular or oval.

      The Episealer® implant is made of biocompatible cobalt/chromium/molybdenum alloy. To enhance
      the osseointegration, the implant is coated with biocompatible hydroxyapatite onto an
      interlaying biocompatible pure titanium coating.

      A previous study (S57685) showed that Episealer is a viable option for focal cartilage
      lesions of the distal femur not responding, or not eligible for, biological treatment options
      (eg. microfracturing). This device is a good solution when there are no alternative
      treatments, except prosthesis surgery, available.

      The goal is to evaluate the efficacy, safety and performance of the Episealer® device in a
      larger sample size and on the long term.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival
time frame: 10 years
description: Presence of the implant in the patient up to 10 years post treatment with loss/revision of the primary implant as endpoint
measure: Radiographic measurements
time frame: 10 years
description: Efficacy will be evaluated with the comparison of the pre- and post- operative radiographs
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: 10 years
description: Performance will be evaluated with the comparison of the pre- and post- operative KOOS-scores. Scoring: each item is scored between 0 and 4 and the raw score of each section is the sum or item scores. The score is then converted into a 0-100 scale. A higher score indicates fewer problems
measure: Visual Analogue Scale (VAS) pain
time frame: 10 years
description: Performance will be evaluated with the comparison of the pre- and post- operative VAS-scores. Score between 0 and 10. Higher score indicates more pain.
measure: Complications
time frame: 10 years
description: Safety will be evaluated by monitoring AEs, unanticipated device effects and subsequent interventions through 10 years post treatment
arm group label: Episealer group
arm group type: Experimental
description: Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible
intervention type: Device
intervention name: Episealer
description: Placing Episealer device
arm group label: Episealer group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hilde Vandenneucker, MD, PhD
role: Principal Investigator
affiliation: UZ Leuven
last name: Lore Hermans, MSc
phone: +32 16338818
email: orthopedie.research@uzleuven.be
last name: Kristel Van de loock, MSc
phone: +32 16341266
email: orthopedie.research@uzleuven.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Knee Injuries
sharing ipd: Undecided
ipd description: To be decided