<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/NCT01670617</url>
  </required_header>
  <id_info>
    <org_study_id>CSU2011-03B</org_study_id>
    <nct_id>NCT01670617</nct_id>
  </id_info>
  <brief_title>DeNovo NT Natural Tissue Graft Stratified Knee Study</brief_title>
  <official_title>A Stratified, Post-Market Study of DeNovo NT for the Treatment of Femoral and Patellar Articular Cartilage Lesions of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer Orthobiologics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zimmer Orthobiologics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the long-term relief of pain and return to function&#xD;
      for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed&#xD;
      product and has been used in more than 7,500 patients over the last 7 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Improvement in KOOS scores</measure>
    <time_frame>Between baseline and 24 months post surgery</time_frame>
    <description>Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>X-ray Evaluation</measure>
    <time_frame>Preop, 12 months and 24 months post surgery</time_frame>
    <description>X-ray evaluation of joint narrowing, and osteophyte and cyst formation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and time to reoperation/revision</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean IKDC Knee Examination grades</measure>
    <time_frame>Annually to 5 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI Evaluation</measure>
    <time_frame>Preop, 12 Months and 24 Months post surgery</time_frame>
    <description>Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Annually to 5 years post surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Defect of Articular Cartilage</condition>
  <condition>Knee Injuries</condition>
  <arm_group>
    <arm_group_label>DeNovo NT Graft</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>DeNovo NT Graft stratified by lesion location - femur or patella</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Particulated Juvenile Articular Cartilage</intervention_name>
    <description>Treatment of articular cartilage defects up to 7.5 cm2</description>
    <arm_group_label>DeNovo NT Graft</arm_group_label>
    <other_name>DeNovo NT Natural Tissue Graft</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          1. Voluntary signature of the IRB approved Informed Consent,&#xD;
&#xD;
          2. Male or female subjects between the ages of 18 to 55 years,&#xD;
&#xD;
          3. If female: Actively practicing a contraception method and willing to continue for a&#xD;
             minimum of 1 year postoperatively, practicing abstinence and willing to continue for a&#xD;
             minimum of 1 year postoperatively, or sterile&#xD;
&#xD;
          4. One or two contained lesion(s) of the femur or patella ≥ ICRS Grade 3 or OCD lesions&#xD;
             with healed bone base with no loss of bone greater than 6mm&#xD;
&#xD;
          5. Has peripheral cartilage debridement to healthy cartilage that results in at least one&#xD;
             lesion with an area of ≥ 2 cm2 and ≤ 7.5 cm2,&#xD;
&#xD;
          6. Lesion(s) to be treated must be contained/shouldered &gt; 70% of the periphery,&#xD;
&#xD;
          7. Ligaments in the affected knee are stable,&#xD;
&#xD;
          8. Ipsilateral knee compartment has intact menisci&#xD;
&#xD;
          9. The contralateral knee is asymptomatic, stable, and fully functional,&#xD;
&#xD;
         10. Is refractory to conservative non-surgical management or minimal surgical intervention&#xD;
             and ≥ 3 months from the start of either treatment,&#xD;
&#xD;
         11. Must record a response, at the preoperative study visit, of moderate to extreme pain&#xD;
             for any one of the KOOS Pain Scale questions, P2 through P9.&#xD;
&#xD;
         12. Must be physically and mentally willing and able, in the Investigator's opinion at the&#xD;
             time of enrollment, to be compliant with the protocol&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Clinical disease diagnosis of the indexed affected joint that includes&#xD;
&#xD;
               -  Osteoarthritis or avascular necrosis,&#xD;
&#xD;
               -  Rheumatoid arthritis, or history of septic or reactive arthritis,&#xD;
&#xD;
               -  Gout or a history of gout or pseudogout in the affected knee,&#xD;
&#xD;
               -  Bipolar articular cartilage involvement (or kissing lesions)&#xD;
&#xD;
               -  Has more than two clinically relevant chondral lesion(s) on the index knee,&#xD;
&#xD;
               -  Osteochondritis dissecans of the knee with significant bone loss&#xD;
&#xD;
               -  Associated damage to the underlying subchondral bone requiring bone graft,&#xD;
&#xD;
               -  Has well-defined subchondral cyst(s),&#xD;
&#xD;
               -  Has current or impending subchondral avascular necrosis,&#xD;
&#xD;
          2. History of secondary arthropathies (i.e., sickle cell disease, hemochromatosis, or&#xD;
             autoimmune disease),&#xD;
&#xD;
          3. Uncontrolled diabetes,&#xD;
&#xD;
          4. Displays a high surgical risk due to unstable cardiac and/or pulmonary disease,&#xD;
&#xD;
          5. Has HIV or other immunodeficient state&#xD;
&#xD;
          6. Is at substantial risk for the need of organ transplantation&#xD;
&#xD;
          7. Is pregnant or breast-feeding,&#xD;
&#xD;
          8. Body Mass Index &gt;35 (BMI=kg/m2),&#xD;
&#xD;
          9. Is participating concurrently in another clinical trial&#xD;
&#xD;
         10. Is receiving prescription pain medication other than NSAIDs or acetaminophen for&#xD;
             conditions unrelated to the index knee condition, chronic use of anticoagulants, or&#xD;
             taking corticosteroids,&#xD;
&#xD;
         11. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the&#xD;
             ability to perform objective functional assessment of either knee,&#xD;
&#xD;
         12. Active joint infection or history of chronic joint infection at the surgical site,&#xD;
&#xD;
         13. Prior total meniscectomy of either knee,&#xD;
&#xD;
         14. Has severe patellofemoral malalignment/maltracking or patellar instability&#xD;
&#xD;
         15. Radiographically has &gt;5 degrees of malalignment&#xD;
&#xD;
         16. Has received, within the past 3 months HA or cortisone injections in knee,&#xD;
&#xD;
         17. Has undergone prior tendon repair, meniscus repair, ligament repair or distal&#xD;
             realignment/osteotomy surgery in the index knee, &lt; 6 months prior to surgery,&#xD;
&#xD;
         18. Failed marrow stimulation or ACI treatment performed &lt; 12-mo before baseline,&#xD;
&#xD;
         19. Index knee has been surgically treated for cartilage repair with OATs, mosaicplasty or&#xD;
             osteochondral allograft,&#xD;
&#xD;
         20. Involves concomitant procedures in the affected knee with the exception of incidental&#xD;
             loose body removal, debridement, synovectomy, retinacular release, and/or partial&#xD;
             meniscectomy&#xD;
&#xD;
         21. Has contraindications for Magnetic Resonance Imaging (MRI),&#xD;
&#xD;
         22. Has an allergy to Polymyxin B sulfate or Bacitracin antibiotics,&#xD;
&#xD;
         23. Is receiving workman's compensation or currently involved in litigation relating to&#xD;
             the index knee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kerlan Jobe Orthopaedics</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naval Medical Center San Deigo</name>
      <address>
        <city>San Deigo</city>
        <state>California</state>
        <zip>92134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Orthopedic Consultants</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andrews Institute for Orthopaedics &amp; Sports Medicine</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Spine &amp; Sports Medicine Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TRIA Orthopaedic Center</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.T. Still University of Health Sciences</name>
      <address>
        <city>Kirksville</city>
        <state>Missouri</state>
        <zip>63501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Orthopaedic Associates</name>
      <address>
        <city>Somerset</city>
        <state>New Jersey</state>
        <zip>08873</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Orthopaedic Consultants</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</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>97201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Military Medical Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madigan Army Medical Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's College Hospital</name>
      <address>
        <city>Toronoto</city>
        <zip>M5S 1B1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Farr J, Cole BJ, Sherman S, Karas V. Particulated articular cartilage: CAIS and DeNovo NT. J Knee Surg. 2012 Mar;25(1):23-9. doi: 10.1055/s-0031-1299652.</citation>
    <PMID>22624244</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</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>
  <!-- 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/NCT01670617
org study id: CSU2011-03B
nct id: NCT01670617
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the long-term relief of pain and return to function
      for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed
      product and has been used in more than 7,500 patients over the last 7 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in KOOS scores
time frame: Between baseline and 24 months post surgery
description: Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores
measure: X-ray Evaluation
time frame: Preop, 12 months and 24 months post surgery
description: X-ray evaluation of joint narrowing, and osteophyte and cyst formation
measure: Incidence and time to reoperation/revision
time frame: 5 years
measure: Mean IKDC Knee Examination grades
time frame: Annually to 5 years post surgery
measure: MRI Evaluation
time frame: Preop, 12 Months and 24 Months post surgery
description: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
measure: Incidence of adverse events
time frame: Annually to 5 years post surgery
arm group label: DeNovo NT Graft
arm group type: Other
description: DeNovo NT Graft stratified by lesion location - femur or patella
intervention type: Other
intervention name: Particulated Juvenile Articular Cartilage
description: Treatment of articular cartilage defects up to 7.5 cm2
arm group label: DeNovo NT Graft
other name: DeNovo NT Natural Tissue Graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
facility: 
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facility: 
facility: 
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country: Canada
country: United States
citation: Farr J, Cole BJ, Sherman S, Karas V. Particulated articular cartilage: CAIS and DeNovo NT. J Knee Surg. 2012 Mar;25(1):23-9. doi: 10.1055/s-0031-1299652.
PMID: 22624244
responsible party type: Sponsor
mesh term: Knee Injuries