<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/NCT02993510</url>
  </required_header>
  <id_info>
    <org_study_id>10830-003</org_study_id>
    <nct_id>NCT02993510</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.</brief_title>
  <official_title>Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geistlich Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Geistlich Pharma AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide®&#xD;
      collagen membrane either sutured or glued compared to microfracture alone in the treatment of&#xD;
      symptomatic cartilage defects of the knee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Prospective, randomized, active treatment-controlled, open-label multicenter study (up&#xD;
           to 40 sites in the US and EU).&#xD;
&#xD;
        -  All subjects that meet preoperative screening eligibility criteria will be randomized to&#xD;
           treatment with Chondro-Gide® either sutured or glued or Microfracture alone.&#xD;
&#xD;
        -  Eligible and consenting subjects are randomized in a 1:1:1 ratio using centralized&#xD;
           randomization list to receive one of the following treatments: Group I: Microfracture&#xD;
           alone; Group II: Microfracture covered with a Chondro-Gide® membrane glued with fibrin&#xD;
           glue (AMIC glued); Group III: Microfracture covered with a Chondro-Gide® membrane&#xD;
           sutured (AMIC sutured)&#xD;
&#xD;
        -  All subjects will be assessed at intervals post-procedure (6 weeks, 3 months, and 1,2&#xD;
           and 5 years).&#xD;
&#xD;
        -  Subjects will be required to follow a strict pre-specified post-surgery rehabilitation&#xD;
           protocol specific to the defect location.&#xD;
&#xD;
        -  Measures to assess effectiveness and safety will be conducted at all follow-ups.&#xD;
&#xD;
        -  Safety will be assessed by the collection of adverse events at all timepoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2003</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 3</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>Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years</measure>
    <time_frame>2 years post-surgery</time_frame>
    <description>The macroscopically assessed integration, surface properties and extent of filling of the defect and the microscopically assessed using the International Cartilage Repair Society (ICRS) score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI (magnetic resonance imaging) assessment of structural repair parameters.</measure>
    <time_frame>6 months and 1,2 and 5 years post-surgery</time_frame>
    <description>Structural repair is assessed with magnetic resonance imaging (MRI, 1.5T) by an independent and blinded radiologist, with a focus on the extent, signal intensity and surface of the defect filling, integration to adjacent cartilage, and bone marrow lesion (BML).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System.</measure>
    <time_frame>6 months and 1,2 and 5 years post-surgery</time_frame>
    <description>The Change from Baseline will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).</measure>
    <time_frame>6 months and 1,2 and 5 years post-surgery</time_frame>
    <description>The Change from Baseline will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) &quot;Cartilage Injury Evaluation Package&quot;.</measure>
    <time_frame>6 months and 1,2 and 5 years post-surgery</time_frame>
    <description>The Change from Baseline will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AE) Review</measure>
    <time_frame>5 years post-surgery</time_frame>
    <description>The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Cartilage Injury</condition>
  <condition>Osteochondritis Dissecans</condition>
  <arm_group>
    <arm_group_label>microfracture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Microfracture is an arthroscopic surgical technique involving placement of microfracture penetrations within the cartilage defect to provide stem cells and growth factors from the bone marrow to aid cartilage repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microfracture with Chondro-Gide sutured</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microfracture with Chondro-Gide glued</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microfracture</intervention_name>
    <description>Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot</description>
    <arm_group_label>microfracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Chondro-Gide sutured</intervention_name>
    <description>Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy</description>
    <arm_group_label>Microfracture with Chondro-Gide sutured</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Chondro-Gide glued</intervention_name>
    <description>Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy</description>
    <arm_group_label>Microfracture with Chondro-Gide glued</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between 18 and 50&#xD;
&#xD;
          -  One or two cartilage defects Grade III or IV according to Outerbridge classification&#xD;
&#xD;
          -  Defect size between 2 and 10 cm2 (inclusive)&#xD;
&#xD;
          -  Intact normal surrounding cartilage to suture the Chondro-Gide® membrane&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Patient willing to fulfill a strict postoperative physiotherapy scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 2 defects&#xD;
&#xD;
          -  Defects on both knees&#xD;
&#xD;
          -  X-ray signs of osteoarthritis&#xD;
&#xD;
          -  Bone lesion &gt; 0.7 cm in the defect&#xD;
&#xD;
          -  Knee instability, varus or valgus deformation, status after complete meniscus&#xD;
             resection, status after mosaicplasty, patella dysplasia&#xD;
&#xD;
          -  Rheumatoid, infectious disease&#xD;
&#xD;
          -  Skin lesion on the operated knee&#xD;
&#xD;
          -  Treatment with cartilage building medication&#xD;
&#xD;
          -  Drug and alcohol abuse&#xD;
&#xD;
          -  Chronic heart disease, endocrine or metabolic disease, Haemophilia A/B&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Collagen allergy&#xD;
&#xD;
          -  Participation in other Trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sven Anders, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Regensburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Regensburg</name>
      <address>
        <city>Bad Abbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Giessen</name>
      <address>
        <city>Giessen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedikum Hamburg</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unfallklinik Hannover</name>
      <address>
        <city>Hanover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Schleswig-Holstein</name>
      <address>
        <city>Lubeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sportklinik Ravensburg</name>
      <address>
        <city>Ravensburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Anders S, Volz M, Frick H, Gellissen J. A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC(R)) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers. Open Orthop J. 2013 May 3;7():133-43. doi: 10.2174/1874325001307010133. Print 2013.</citation>
    <PMID>23730377</PMID>
  </results_reference>
  <results_reference>
    <citation>Volz M, Schaumburger J, Frick H, Grifka J, Anders S. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop. 2017 Apr;41(4):797-804. doi: 10.1007/s00264-016-3391-0. Epub 2017 Jan 20.</citation>
    <PMID>28108777</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>February 20, 2017</last_update_submitted>
  <last_update_submitted_qc>February 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>microfracture</keyword>
  <keyword>enhanced marrow stimulation</keyword>
  <keyword>articular cartilage</keyword>
  <keyword>Autologous Matrix-Induced Chondrogenesis</keyword>
  <keyword>Chondro-Gide®</keyword>
  <keyword>knee surgery</keyword>
  <keyword>AMIC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteochondritis</mesh_term>
    <mesh_term>Osteochondritis Dissecans</mesh_term>
  </condition_browse>
  <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/NCT02993510
org study id: 10830-003
nct id: NCT02993510
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide®
      collagen membrane either sutured or glued compared to microfracture alone in the treatment of
      symptomatic cartilage defects of the knee.
-  Prospective, randomized, active treatment-controlled, open-label multicenter study (up
           to 40 sites in the US and EU).

        -  All subjects that meet preoperative screening eligibility criteria will be randomized to
           treatment with Chondro-Gide® either sutured or glued or Microfracture alone.

        -  Eligible and consenting subjects are randomized in a 1:1:1 ratio using centralized
           randomization list to receive one of the following treatments: Group I: Microfracture
           alone; Group II: Microfracture covered with a Chondro-Gide® membrane glued with fibrin
           glue (AMIC glued); Group III: Microfracture covered with a Chondro-Gide® membrane
           sutured (AMIC sutured)

        -  All subjects will be assessed at intervals post-procedure (6 weeks, 3 months, and 1,2
           and 5 years).

        -  Subjects will be required to follow a strict pre-specified post-surgery rehabilitation
           protocol specific to the defect location.

        -  Measures to assess effectiveness and safety will be conducted at all follow-ups.

        -  Safety will be assessed by the collection of adverse events at all timepoints.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years
time frame: 2 years post-surgery
description: The macroscopically assessed integration, surface properties and extent of filling of the defect and the microscopically assessed using the International Cartilage Repair Society (ICRS) score
measure: MRI (magnetic resonance imaging) assessment of structural repair parameters.
time frame: 6 months and 1,2 and 5 years post-surgery
description: Structural repair is assessed with magnetic resonance imaging (MRI, 1.5T) by an independent and blinded radiologist, with a focus on the extent, signal intensity and surface of the defect filling, integration to adjacent cartilage, and bone marrow lesion (BML).
measure: Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System.
time frame: 6 months and 1,2 and 5 years post-surgery
description: The Change from Baseline will be evaluated.
measure: Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).
time frame: 6 months and 1,2 and 5 years post-surgery
description: The Change from Baseline will be evaluated.
measure: Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package".
time frame: 6 months and 1,2 and 5 years post-surgery
description: The Change from Baseline will be evaluated.
measure: Adverse Events (AE) Review
time frame: 5 years post-surgery
description: The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.
arm group label: microfracture
arm group type: Active Comparator
description: Microfracture is an arthroscopic surgical technique involving placement of microfracture penetrations within the cartilage defect to provide stem cells and growth factors from the bone marrow to aid cartilage repair
arm group label: Microfracture with Chondro-Gide sutured
arm group type: Experimental
description: Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure
arm group label: Microfracture with Chondro-Gide glued
arm group type: Experimental
description: Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure
intervention type: Procedure
intervention name: Microfracture
description: Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot
arm group label: microfracture
intervention type: Device
intervention name: Chondro-Gide sutured
description: Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy
arm group label: Microfracture with Chondro-Gide sutured
intervention type: Device
intervention name: Chondro-Gide glued
description: Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy
arm group label: Microfracture with Chondro-Gide glued
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sven Anders, MD
role: Principal Investigator
affiliation: University of Regensburg
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
citation: Anders S, Volz M, Frick H, Gellissen J. A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC(R)) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers. Open Orthop J. 2013 May 3;7():133-43. doi: 10.2174/1874325001307010133. Print 2013.
PMID: 23730377
citation: Volz M, Schaumburger J, Frick H, Grifka J, Anders S. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop. 2017 Apr;41(4):797-804. doi: 10.1007/s00264-016-3391-0. Epub 2017 Jan 20.
PMID: 28108777
responsible party type: Sponsor
mesh term: Osteochondritis
mesh term: Osteochondritis Dissecans
sharing ipd: No