<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/NCT03262909</url>
  </required_header>
  <id_info>
    <org_study_id>CLN-GR-01</org_study_id>
    <nct_id>NCT03262909</nct_id>
  </id_info>
  <brief_title>Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects</brief_title>
  <acronym>SAGE</acronym>
  <official_title>A Prospective, Open-Label, Multicenter Pivotal Study to Evaluate the Safety and Efficacy of GelrinC® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle: A Comparison to Historical Control Microfracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regentis Biomaterials</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regentis Biomaterials</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective&#xD;
      treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a&#xD;
      historical control arm (microfracture) in the treatment of cartilage defects in the knee.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 14, 2017</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).</measure>
    <time_frame>24 months post-surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).</measure>
    <time_frame>24 months post-surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">181</enrollment>
  <condition>Articular Cartilage Defects in the Knee Joint</condition>
  <arm_group>
    <arm_group_label>GelrinC prospective treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo GelrinC implantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microfracture historical control arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Microfracture historical control arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GelrinC</intervention_name>
    <description>Patients will undergo GelrinC implantation.</description>
    <arm_group_label>GelrinC prospective treatment arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Microfracture historical control arm</intervention_name>
    <description>Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.</description>
    <arm_group_label>Microfracture historical control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 50.&#xD;
&#xD;
          -  Single contained symptomatic lesion located on the femoral condyle of the femur graded&#xD;
             as ICRS III or IV with less than 5 mm of bone loss below the subchondral plate.&#xD;
&#xD;
          -  Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in&#xD;
             diameter.&#xD;
&#xD;
          -  BMI ≤35&#xD;
&#xD;
          -  Contralateral knee is asymptomatic, stable, fully functional and not medically&#xD;
             treated.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Presence of an additional grade III or IV symptomatic lesion.&#xD;
&#xD;
          -  Recent Osteochondritis Dissecans within 1 year of baseline visit.&#xD;
&#xD;
          -  Untreated ACL and/or PCL deficiency or Complex ligamentous instability of the knee.&#xD;
&#xD;
          -  Patient is excluded if presenting untreated current meniscal tear or if previous&#xD;
             menisci resection was within the last 6 months.&#xD;
&#xD;
          -  Previous tendon repair or ligament reconstruction within the last 6 months.&#xD;
&#xD;
          -  Failed Mosaicplasty or ACI or MACI or any other cartilage repair product.&#xD;
&#xD;
          -  Microfracture performed less than 1 year before baseline visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Horizon Clinical Research</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hoag Orthopedics</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shrock Clinical Research</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andrews Institute</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewett Orthopaedic Clinic</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optim Orthopedics</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Orthopaedics at Rush</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</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>Tria Institute</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alpine Orthopedics</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Orthopedics Center</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mansfield Orthopedics</name>
      <address>
        <city>Morrisville</city>
        <state>Vermont</state>
        <zip>05661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Trattnig S, Ohel K, Mlynarik V, Juras V, Zbyn S, Korner A. Morphological and compositional monitoring of a new cell-free cartilage repair hydrogel technology - GelrinC by MR using semi-quantitative MOCART scoring and quantitative T2 index and new zonal T2 index calculation. Osteoarthritis Cartilage. 2015 Dec;23(12):2224-2232. doi: 10.1016/j.joca.2015.07.007. Epub 2015 Jul 14.</citation>
    <PMID>26187572</PMID>
  </reference>
  <reference>
    <citation>Berdichevski A, Shachaf Y, Wechsler R, Seliktar D. Protein composition alters in vivo resorption of PEG-based hydrogels as monitored by contrast-enhanced MRI. Biomaterials. 2015 Feb;42:1-10. doi: 10.1016/j.biomaterials.2014.11.015. Epub 2014 Dec 9.</citation>
    <PMID>25542788</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 20, 2022</last_update_submitted>
  <last_update_submitted_qc>March 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cartilage damage</keyword>
  <keyword>cartilage defect</keyword>
  <keyword>chondral lesion</keyword>
  <keyword>osteochondral lesion</keyword>
  <keyword>femur</keyword>
  <keyword>condyle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cartilage Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03262909
org study id: CLN-GR-01
nct id: NCT03262909
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective
      treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a
      historical control arm (microfracture) in the treatment of cartilage defects in the knee.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
time frame: 24 months post-surgery
measure: The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
time frame: 24 months post-surgery
arm group label: GelrinC prospective treatment arm
arm group type: Experimental
description: Patients will undergo GelrinC implantation.
arm group label: Microfracture historical control arm
arm group type: Other
description: Microfracture historical control arm
intervention type: Device
intervention name: GelrinC
description: Patients will undergo GelrinC implantation.
arm group label: GelrinC prospective treatment arm
intervention type: Other
intervention name: Microfracture historical control arm
description: Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.
arm group label: Microfracture historical control arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Trattnig S, Ohel K, Mlynarik V, Juras V, Zbyn S, Korner A. Morphological and compositional monitoring of a new cell-free cartilage repair hydrogel technology - GelrinC by MR using semi-quantitative MOCART scoring and quantitative T2 index and new zonal T2 index calculation. Osteoarthritis Cartilage. 2015 Dec;23(12):2224-2232. doi: 10.1016/j.joca.2015.07.007. Epub 2015 Jul 14.
PMID: 26187572
citation: Berdichevski A, Shachaf Y, Wechsler R, Seliktar D. Protein composition alters in vivo resorption of PEG-based hydrogels as monitored by contrast-enhanced MRI. Biomaterials. 2015 Feb;42:1-10. doi: 10.1016/j.biomaterials.2014.11.015. Epub 2014 Dec 9.
PMID: 25542788
responsible party type: Sponsor
mesh term: Cartilage Diseases
sharing ipd: Undecided