<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/NCT03307668</url>
  </required_header>
  <id_info>
    <org_study_id>3.0</org_study_id>
    <nct_id>NCT03307668</nct_id>
  </id_info>
  <brief_title>Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee</brief_title>
  <official_title>Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee: a Randomised, Multicentre, Open-label, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arthro-Anda Tianjin Biologic Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arthro-Anda Tianjin Biologic Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee&#xD;
      cartilage defects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native&#xD;
      Collagen type I. It is indicated for the defect filling of focal, full layer and clearly&#xD;
      defined knee and ankle cartilage defects of longest diameter 1.1-2.2cm. The fixation of&#xD;
      CaReSR-1S is made for all sizes with fibrin glue, whereas the 11 mm implants also allow a&#xD;
      press-fit anchoring due to the elasticity of the implant.&#xD;
&#xD;
      The physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as&#xD;
      progenitor cells from the surrounding healthy tissue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference of MOCART score change from baseline between groups</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of Lysholm score change from baseline between groups</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Good&quot;&quot;Moderate&quot;&quot;Poor&quot; rates according to Lysholm score</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effective rate according to Lysholm score</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total efficiency according to Lysholm score</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-related adverse events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Cartilage Defects</condition>
  <arm_group>
    <arm_group_label>CaReS-1S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Microfracture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CaReSR-1S</intervention_name>
    <description>CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.</description>
    <arm_group_label>CaReS-1S</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microfracture</intervention_name>
    <description>Microfracture is an articular cartilage repair surgical technique that works by creating tiny fractures in the underlying bone. This causes new cartilage to develop from a so-called super-clot.</description>
    <arm_group_label>Microfracture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged from 18 to 55 years old;&#xD;
&#xD;
          2. Diagnosed with isolated knee cartilage defects in condyles of femur by arthroscopy,&#xD;
             and the longest diameter is 1.1-2.2cm. The degree of the cartilage defects is&#xD;
             Outerbridge IV degree or III degree but approximate to IV degree;&#xD;
&#xD;
          3. Outerbridge degree of cartilage in the other articular facet ≤Ⅱ;&#xD;
&#xD;
          4. Normal lower limb mechanical force line (varus or valgum &lt; 5°);&#xD;
&#xD;
          5. Skeletal mature;&#xD;
&#xD;
          6. 18Kg/M2 ≤ BMI ≤ 30Kg/M2;&#xD;
&#xD;
          7. Agree to sign the informed consent form;&#xD;
&#xD;
          8. Can cooperate in a post-operative rehabilitation program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Superficial cartilage defects;&#xD;
&#xD;
          2. Concomitant with subchondral bone defect;&#xD;
&#xD;
          3. Varus or valgum &gt; 5°;&#xD;
&#xD;
          4. Serious meniscus injury;&#xD;
&#xD;
          5. Fractures around the knee;&#xD;
&#xD;
          6. Cannot join in the post-operative rehabilitation program;&#xD;
&#xD;
          7. The contralateral lower-limb cannot stand weight-bearing;&#xD;
&#xD;
          8. A history of knee surgery within 6 months;&#xD;
&#xD;
          9. Secondary arthritis affecting cartilage;&#xD;
&#xD;
         10. Serious arthrocleisis;&#xD;
&#xD;
         11. Undergoing clinical trial;&#xD;
&#xD;
         12. Serious illness of the heart, lung, and other vital organs;&#xD;
&#xD;
         13. Liver function test equal to two times or greater than the upper normal limits; serum&#xD;
             creatinine equal to two times or greater than the upper normal limit;&#xD;
&#xD;
         14. Have a contagious disease;&#xD;
&#xD;
         15. Allergic to the agents;&#xD;
&#xD;
         16. Lactating or pregnant women;&#xD;
&#xD;
         17. Serious neuropathy or mental disease;&#xD;
&#xD;
         18. Be addicted with drug or alcohol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dong-xing Xie, PhD</last_name>
    <phone>86073189753006</phone>
    <email>491703175@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiangya Hospital, Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guang-hua Lei</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03307668
org study id: 3.0
nct id: NCT03307668
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee
      cartilage defects.
CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native
      Collagen type I. It is indicated for the defect filling of focal, full layer and clearly
      defined knee and ankle cartilage defects of longest diameter 1.1-2.2cm. The fixation of
      CaReSR-1S is made for all sizes with fibrin glue, whereas the 11 mm implants also allow a
      press-fit anchoring due to the elasticity of the implant.

      The physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as
      progenitor cells from the surrounding healthy tissue.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference of Magnetic resonance observation of cartilage repair tissue (MOCART) score between two groups
time frame: 12 months
measure: Difference of MOCART score change from baseline between groups
time frame: 12 months
measure: Difference of International Knee Documentation Committee (IKDC) Subjective Knee Form score change from baseline between groups
time frame: 12 months
measure: Difference of Lysholm score change from baseline between groups
time frame: 12 months
measure: "Good""Moderate""Poor" rates according to Lysholm score
time frame: 12 months
measure: Effective rate according to Lysholm score
time frame: 12 months
measure: Total efficiency according to Lysholm score
time frame: 12 months
measure: Incidence of treatment-related adverse events
time frame: 12 months
arm group label: CaReS-1S
arm group type: Experimental
arm group label: Microfracture
arm group type: Active Comparator
intervention type: Device
intervention name: CaReSR-1S
description: CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.
arm group label: CaReS-1S
intervention type: Device
intervention name: Microfracture
description: Microfracture is an articular cartilage repair surgical technique that works by creating tiny fractures in the underlying bone. This causes new cartilage to develop from a so-called super-clot.
arm group label: Microfracture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Dong-xing Xie, PhD
phone: 86073189753006
email: 491703175@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: No