<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/NCT03299959</url>
  </required_header>
  <id_info>
    <org_study_id>CLN0021</org_study_id>
    <nct_id>NCT03299959</nct_id>
  </id_info>
  <brief_title>Agili-C™ Implant Performance Evaluation</brief_title>
  <official_title>A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cartiheal (2009) Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cartiheal (2009) Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study compares the efficacy and safety of the Agili-C implant to Surgical&#xD;
      Standard of Care treatment in patients suffering from joint surface lesions of the knee. The&#xD;
      patient population is heterogeneous, involving different kinds of joint surface lesions:&#xD;
      focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including&#xD;
      multiple defects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™&#xD;
      vs. SSOC for the repair of joint surface lesions.&#xD;
&#xD;
      Follow-up visits will be performed at 2 weeks and at 3, 6, 12, 18 and 24 months&#xD;
      post-procedure to evaluate the patient's knee condition and clinical health. The following&#xD;
      questionnaires: KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation ,&#xD;
      SF-12 Health Survey, Tegner Activity Score will be completed at baseline and at 6, 12, 18 and&#xD;
      24 months. Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at&#xD;
      6, 12, 18 and 24 months post procedure. MRI according to specific protocol will be performed&#xD;
      at 12 and 24 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2024</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Open-label Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open-Label, adaptive design with interim analyses</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>KOOS Score</measure>
    <time_frame>Preoperative until 2 years postoperatively</time_frame>
    <description>Knee Injury and Osteoarthritis Outcome Score (KOOS)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">251</enrollment>
  <condition>Cartilage or Osteochondral Defects in the Knee</condition>
  <condition>Up to Moderate Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Agili-C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical Standard of Care (SSOC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Agili-C implant</intervention_name>
    <description>Agili-C implant</description>
    <arm_group_label>Agili-C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SSOC</intervention_name>
    <description>microfracture and/or debridement</description>
    <arm_group_label>Surgical Standard of Care (SSOC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 21 -75 years&#xD;
&#xD;
          2. Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral&#xD;
             condyles and/or trochlea&#xD;
&#xD;
          3. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in&#xD;
             the calculation&#xD;
&#xD;
          4. Must be physically and mentally willing and able to comply with the post-operative&#xD;
             rehabilitation protocol and scheduled clinical and radiographic visits&#xD;
&#xD;
          5. Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if&#xD;
             applicable)&#xD;
&#xD;
          6. Non-responsive to physical therapy for at least 3-4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum&#xD;
             pain =0, pain free =100)&#xD;
&#xD;
          2. Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy&#xD;
&#xD;
          3. Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above&#xD;
&#xD;
          4. Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading&#xD;
&#xD;
          5. Significant instability of the index knee according to IKDC Knee Examination Form&#xD;
             2000, Grade C (abnormal) or D (severely abnormal)&#xD;
&#xD;
          6. Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray&#xD;
&#xD;
          7. Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure&#xD;
&#xD;
          8. Meniscal transplantation in the past 6 months&#xD;
&#xD;
          9. Any known tumor of the index knee&#xD;
&#xD;
         10. Any known history of intra-articular or osseous infection of the index knee&#xD;
&#xD;
         11. Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI)&#xD;
             patients can be included following antibiotic treatment, and provided that two&#xD;
             consecutive cultures are negative (taken within at least 2 weeks of each other)&#xD;
&#xD;
         12. Any known history of inflammatory arthropathy or crystal-deposition arthropathy&#xD;
&#xD;
         13. Any known systemic cartilage and/or bone disorder, such as but not limited to,&#xD;
             osteoporosis, chondrodysplasia or osteogenesis imperfecta&#xD;
&#xD;
         14. Body Mass Index (BMI) &gt; 35&#xD;
&#xD;
         15. Chemotherapy in the past 12 months&#xD;
&#xD;
         16. Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in&#xD;
             the index knee within the last 6 months&#xD;
&#xD;
         17. Any previous ligamentous repair or malalignment correction in the index knee within&#xD;
             the last 6 months&#xD;
&#xD;
         18. History of allergic reaction or intolerance of materials containing calcium carbonate&#xD;
             or hyaluronate&#xD;
&#xD;
         19. Patient who is pregnant or intends to become pregnant during the study&#xD;
&#xD;
         20. History of any significant systemic disease, such as but not limited to: HIV,&#xD;
             hepatitis, HTLV, syphilis, and coagulopathies&#xD;
&#xD;
         21. Known substance or alcohol abuse&#xD;
&#xD;
         22. Participation in other clinical trials within 60 days prior to the study or concurrent&#xD;
             with the study&#xD;
&#xD;
         23. Known insulin dependent diabetes mellitus&#xD;
&#xD;
         24. Unable to undergo either MRI or X-ray&#xD;
&#xD;
         25. Use of anticoagulation medication or antiaggregant medication; however up to 100 mg&#xD;
             Acetylsalicylic acid (ASA) daily is allowed&#xD;
&#xD;
         26. Previous intra-articular steroid injection within the last 1 month&#xD;
&#xD;
         27. Prisoners&#xD;
&#xD;
         28. Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely&#xD;
             surrounding the lesion - based on MRI/X-ray/arthroscopy&#xD;
&#xD;
         29. Inability to position the implant 2mm recessed relative to the articular surface -&#xD;
             based on MRI/X-ray/arthroscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizaveta Kon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Horizon Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSU Healthcare Network Orthopedic &amp; Sports Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Orthopaedic Associates</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri, Missouri Orthopaedic Institute</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Orthopedic Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University, Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arlington Orthopedic Associates</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoVirginia</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Monica</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uzsoki Utcai Kórház</name>
      <address>
        <city>Budapest</city>
        <zip>1114</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kastélypark Klinika</name>
      <address>
        <city>Tata</city>
        <zip>2892</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center</name>
      <address>
        <city>Be'er Ya'aqov</city>
        <zip>60930</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Carmel&quot; Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3436212</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hasharon Hospital, Petach Tikva</name>
      <address>
        <city>Petach Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Souraski Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Humanitas Gavazzeni</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialist Hospital. Louis Rydygier in Krakow</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>County Hospital Timis Othopedy and Trauma Clinic</name>
      <address>
        <city>Timişoara</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlas General hospital</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic for Orthopedic Surgery &quot;Banjica&quot;</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center of Vojvodina</name>
      <address>
        <city>Novi Sad</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Serbia</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Slovenia</country>
  </removed_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</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>
  </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/NCT03299959
org study id: CLN0021
nct id: NCT03299959
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The current study compares the efficacy and safety of the Agili-C implant to Surgical
      Standard of Care treatment in patients suffering from joint surface lesions of the knee. The
      patient population is heterogeneous, involving different kinds of joint surface lesions:
      focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including
      multiple defects.
This is a prospective, multicenter, open-label, randomized, and controlled trial of Agili-C™
      vs. SSOC for the repair of joint surface lesions.

      Follow-up visits will be performed at 2 weeks and at 3, 6, 12, 18 and 24 months
      post-procedure to evaluate the patient's knee condition and clinical health. The following
      questionnaires: KOOS, IKDC Knee Examination Form 2000, IKDC Subjective Knee Evaluation ,
      SF-12 Health Survey, Tegner Activity Score will be completed at baseline and at 6, 12, 18 and
      24 months. Anterior-Posterior (A/P) and Lateral knee X-rays will be taken at 2 weeks and at
      6, 12, 18 and 24 months post procedure. MRI according to specific protocol will be performed
      at 12 and 24 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open-label Randomized Controlled Trial
primary purpose: Treatment
masking: None (Open Label)
masking description: Open-Label, adaptive design with interim analyses
measure: KOOS Score
time frame: Preoperative until 2 years postoperatively
description: Knee Injury and Osteoarthritis Outcome Score (KOOS)
arm group label: Agili-C
arm group type: Experimental
arm group label: Surgical Standard of Care (SSOC)
arm group type: Active Comparator
intervention type: Device
intervention name: Agili-C implant
description: Agili-C implant
arm group label: Agili-C
intervention type: Procedure
intervention name: SSOC
description: microfracture and/or debridement
arm group label: Surgical Standard of Care (SSOC)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Elizaveta Kon, MD
role: Principal Investigator
affiliation: Istituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy
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country: Belgium
country: Hungary
country: Israel
country: Italy
country: Poland
country: Romania
country: Serbia
country: United States
country: France
country: Slovenia
responsible party type: Sponsor
mesh term: Osteoarthritis