<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/NCT01712191</url>
  </required_header>
  <id_info>
    <org_study_id>00017</org_study_id>
    <nct_id>NCT01712191</nct_id>
  </id_info>
  <brief_title>Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant</brief_title>
  <official_title>Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Active Implants</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Active Implants</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, open label, non-randomized study, evaluating the&#xD;
      treating of medial meniscus deficiency with the NUsurface Meniscus Implant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2011</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Knee injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>24 Months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Meniscus; Degeneration</condition>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>NUsurface Meniscus Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NUsurface Meniscus Implant</intervention_name>
    <arm_group_label>NUsurface Meniscus Implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by&#xD;
             diagnostic MRI.&#xD;
&#xD;
          2. Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.&#xD;
&#xD;
          3. Be in neutral alignment +/- 5 degrees of the mechanical axis.&#xD;
&#xD;
          4. Be between age 35 and 75 at the time of the planned surgery.&#xD;
&#xD;
          5. Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.&#xD;
&#xD;
          6. Have a normal mental status.&#xD;
&#xD;
          7. Be willing and able to attend all follow up visits, complete all study questionnaires,&#xD;
             and undergo required X-ray and MRI schedule.&#xD;
&#xD;
          8. Be able and willing to understand and sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or&#xD;
             femoral condyle that could contact the NUsurface implant&#xD;
&#xD;
          2. Have lateral compartment pain with lateral articular cartilage damage greater than&#xD;
             Grade II (OB), and/or a lateral meniscus tear(s)&#xD;
&#xD;
          3. Have a varus or valgus knee deformity &gt; 5 degrees.&#xD;
&#xD;
          4. Have a laxity level of more than II (ICRS), secondary to previous injury of the&#xD;
             anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or&#xD;
             lateral collateral ligament (LCL) and/or medial collateral ligament (MCL).&#xD;
&#xD;
          5. Have patella instability or non-anatomically positioned patella&#xD;
&#xD;
          6. Have patellar compartment pain and/or patellar articular cartilage damage greater than&#xD;
             Grade II (OB).&#xD;
&#xD;
          7. Need a tibial osteotomy at the time of surgery.&#xD;
&#xD;
          8. Have an ACL reconstruction performed less than 9 months before implanting the&#xD;
             NUsurface® device&#xD;
&#xD;
          9. Have any type of previously implanted prosthetic meniscus or ligament or knee implant&#xD;
             made of plastic.&#xD;
&#xD;
         10. Have a knee flexion contracture &gt; 10 degrees&#xD;
&#xD;
         11. Be unable to flex the knee to 90 degrees&#xD;
&#xD;
         12. Have a leg length discrepancy causing a noticeable limp.&#xD;
&#xD;
         13. Have had a previous major knee condyle surgery&#xD;
&#xD;
         14. Present with insufficiency fractures or avascular necrosis of the medial compartment.&#xD;
&#xD;
         15. Have an active infection or tumor.&#xD;
&#xD;
         16. Have any type of knee joint inflammatory disease including Sjogren's syndrome.&#xD;
&#xD;
         17. Have neuropathic knee osteoarthropathy, also known as Charcot joint.&#xD;
&#xD;
         18. Have any medical condition that does not allow arthroscopy at the point of entry to&#xD;
             the knee.&#xD;
&#xD;
         19. Be pregnant or is a female intending to become pregnant during the study period.&#xD;
&#xD;
         20. Be mentally incapacitated.&#xD;
&#xD;
         21. Be a prisoner.&#xD;
&#xD;
         22. Be a patient who has economic incentive not to improve (e.g., workman's compensation&#xD;
             patient)&#xD;
&#xD;
         23. Be morbidly Obese (BMI &gt; 35).&#xD;
&#xD;
         24. Is unwilling or unable to have an X-ray, Fluro, or MRI of the affected knee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AZ Monica</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sporthopaedicum Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniKlinikum Regensburg</name>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emek Medical Center</name>
      <address>
        <city>Afula</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center- Ichilov</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center</name>
      <address>
        <city>Zerifin</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacro Cuore- Don Calabria Hospital</name>
      <address>
        <city>Negrar</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Centre</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska universitetssjukhuset</name>
      <address>
        <city>Göteborg</city>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NUsurface</keyword>
  <keyword>Meniscus</keyword>
  <keyword>Knee</keyword>
  <keyword>KOOS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</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/NCT01712191
org study id: 00017
nct id: NCT01712191
lead sponsor: 
has dmc: Yes
This is a prospective, multi-center, open label, non-randomized study, evaluating the
      treating of medial meniscus deficiency with the NUsurface Meniscus Implant.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: 24 Months
arm group label: NUsurface Meniscus Implant
arm group type: Experimental
intervention type: Device
intervention name: NUsurface Meniscus Implant
arm group label: NUsurface Meniscus Implant
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Germany
country: Israel
country: Italy
country: Netherlands
country: Sweden
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee