<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/NCT01690689</url>
  </required_header>
  <id_info>
    <org_study_id>ALCR-120412-01</org_study_id>
    <nct_id>NCT01690689</nct_id>
  </id_info>
  <brief_title>Investigation of a Customized Femoral Resurfacing Implant</brief_title>
  <acronym>Knee100</acronym>
  <official_title>Investigation of a Customized Femoral Resurfacing Implant (Episealer® Knee Condyle Device) to Assess the Safety Profile and Performance for 2 Years Post-operatively</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Episurf Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Episurf Medical Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose is to assess the safety profile and performance of a femoral resurfacing implant&#xD;
      for localized chondral lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The implant's safety profile will be assessed by incidence of any subject having any of the&#xD;
      seven identified implant-related clinical undesirable side effects. This will be analyzed&#xD;
      with a one-side exact binomial test on significance level 0.05, at 24 months&#xD;
      post-operatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</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>Number of participants with Adverse Events</measure>
    <time_frame>24 months</time_frame>
    <description>The primary efficacy analysis in this study is to ascertain that the incidence of at least one subject having any of the seven identified clinical undesirable side effects is lower than 38 % (risk profile of the comparator) up to the 24 months analysis in the PP population. This will be analyzed with a one-side exact binomial test on significance level 0.05</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical performance</measure>
    <time_frame>24 months</time_frame>
    <description>Clinical performance, by questionnaires and knee ROM measurements.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Articular Cartilage Disorder</condition>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implant surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implant surgery</intervention_name>
    <description>surgery</description>
    <arm_group_label>Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female&#xD;
&#xD;
          2. Age 30 ≤ 65 years&#xD;
&#xD;
          3. Chondral defects of the femoral cartilage ICRS grade 3 (severely abnormal cartilage&#xD;
             defects &gt; 50% of the cartilage depth) or grade 4 (severely abnormal, through the&#xD;
             cartilage depth) on medial or lateral femoral condyles&#xD;
&#xD;
          4. Cartilage lesion area &lt; 3.2 cm2 (diameter &lt; 2 cm)&#xD;
&#xD;
          5. Failed earlier conservative or surgical interventions such as lavage, abrasions,&#xD;
             drilling or microfracture&#xD;
&#xD;
          6. VAS-pain symptom &gt;40 for more than 6 months&#xD;
&#xD;
          7. The arthroscopic finding corresponds to the expected; size of cartilage lesion is&#xD;
             correct and no other significant pathology (see CIP, &quot;Intra-operative check-list&quot;,&#xD;
             Appendix I)&#xD;
&#xD;
          8. Capable of completing self-administered questionnaires&#xD;
&#xD;
          9. Willing to comply with the follow-up requirements of the study&#xD;
&#xD;
         10. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. BMI ≥ 35 kg/m2 (severe obesity)&#xD;
&#xD;
          2. Instability or deficiency of soft tissues, vascular or muscular insufficiency&#xD;
&#xD;
          3. Metabolic disorders which may impair bone formation&#xD;
&#xD;
          4. Diabetes mellitus&#xD;
&#xD;
          5. Smokers&#xD;
&#xD;
          6. Diagnosis of a concomitant knee injury which the Investigator appreciates may&#xD;
             interfere with study participation (i.e. may confound efficacy assessment or healing&#xD;
             at the involved knee joint level)&#xD;
&#xD;
          7. Irresolvable joint pain or loss-of-function with an undeterminable cause&#xD;
&#xD;
          8. Diagnosis of a concomitant meniscal injury in involved knee that requires surgical&#xD;
             intervention&#xD;
&#xD;
          9. Loss of joint space on standing radiographs (≥ 1 on Ahlbäck-scale (0-5))&#xD;
&#xD;
         10. Avascular necrosis&#xD;
&#xD;
         11. Infections, systemic or local&#xD;
&#xD;
         12. Known metal allergies&#xD;
&#xD;
         13. History of inflammatory arthritis&#xD;
&#xD;
         14. Pregnancy&#xD;
&#xD;
         15. Pacemaker implant&#xD;
&#xD;
         16. History of drug or substance abuse&#xD;
&#xD;
         17. Systemic administration within 30 days prior to the study of any type of&#xD;
             corticosteroid, antineoplastics, immune stimulating or immunosuppressive agents&#xD;
&#xD;
         18. Participation in another clinical trial using an investigational new drug or device&#xD;
             within 30 days of entrance into this study.&#xD;
&#xD;
         19. Condition that may have an impact on the outcome of the investigation as judged by the&#xD;
             Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick Zetterberg</last_name>
    <role>Study Director</role>
    <affiliation>Episurf Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lund University Hospital, Department of Ortopedics</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aleris Specialistvård</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sports Medicine Umeå</name>
      <address>
        <city>Umeå</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>December 14, 2020</last_update_submitted>
  <last_update_submitted_qc>December 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 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>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/NCT01690689
org study id: ALCR-120412-01
nct id: NCT01690689
lead sponsor: 
has dmc: Yes
The purpose is to assess the safety profile and performance of a femoral resurfacing implant
      for localized chondral lesions.
The implant's safety profile will be assessed by incidence of any subject having any of the
      seven identified implant-related clinical undesirable side effects. This will be analyzed
      with a one-side exact binomial test on significance level 0.05, at 24 months
      post-operatively.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with Adverse Events
time frame: 24 months
description: The primary efficacy analysis in this study is to ascertain that the incidence of at least one subject having any of the seven identified clinical undesirable side effects is lower than 38 % (risk profile of the comparator) up to the 24 months analysis in the PP population. This will be analyzed with a one-side exact binomial test on significance level 0.05
measure: Clinical performance
time frame: 24 months
description: Clinical performance, by questionnaires and knee ROM measurements.
arm group label: Surgery
arm group type: Experimental
description: Implant surgery
intervention type: Device
intervention name: Implant surgery
description: surgery
arm group label: Surgery
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Frederick Zetterberg
role: Study Director
affiliation: Episurf Medical
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Cartilage Diseases