<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/NCT02205645</url>
  </required_header>
  <id_info>
    <org_study_id>ORX/2014/FM01</org_study_id>
    <nct_id>NCT02205645</nct_id>
  </id_info>
  <brief_title>Initial Safety Evaluation of FibroFix™ Meniscus</brief_title>
  <official_title>A Prospective Open-Label Study to Evaluate the Safety of the Meniscal Repair Scaffold, FibroFix™ Meniscus, in the Treatment of Meniscal Defects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orthox Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bristol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Orthox Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The safety of the FibroFix™ Meniscus scaffold will be evaluated in 10 patients scheduled for&#xD;
      elective arthroscopic medial meniscus partial resection or treatment of asymptomatic medial&#xD;
      meniscal defect&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Safety. Devices explanted. 12m post-explant safety f/u as agreed with UK MHRA&#xD;
  </why_stopped>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">October 17, 2017</completion_date>
  <primary_completion_date type="Actual">October 17, 2017</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>Safety</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants with Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>7 years</time_frame>
    <description>Number of participants with Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional assessment</measure>
    <time_frame>7 years</time_frame>
    <description>Assessments will be made using recognized and validated tools: Tegner Index, Lysholm Score, International Knee Documentation Committee (IKDC) Score and range of motion of knee</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain scores</measure>
    <time_frame>12m</time_frame>
    <description>Assessments will be made using recognized and validated tools: Tegner index, Lysholm score, International Knee Documentation Committee (IKDC) score, VAS scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional assessment</measure>
    <time_frame>12m</time_frame>
    <description>Assessments will be made using recognized and validated tools: Tegner Index, Lysholm Score, International Knee Documentation Committee (IKDC) score and range of motion of knee</description>
  </other_outcome>
  <other_outcome>
    <measure>Post operative infection</measure>
    <time_frame>12m</time_frame>
    <description>Diagnosis of infection will be made on clinical grounds. If infection is diagnosed, a confirmatory bacterial culture will be collected and analysed locally. Assessment will include the patient, tissues around the wound and the wound itself.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Other Tear of Medial Meniscus, Current Injury</condition>
  <arm_group>
    <arm_group_label>FibroFix™ Meniscus scaffold</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test article for this study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus. It is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FibroFix™ Meniscus scaffold</intervention_name>
    <description>The test article for this study is the FibroFix™ Meniscus scaffold supplied by Orthox Ltd. The FibroFix™ Meniscus scaffold has been developed for repair of defects of the meniscus.&#xD;
The FibroFix™ Meniscus scaffold used in this study is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.</description>
    <arm_group_label>FibroFix™ Meniscus scaffold</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject (or guardian, if appropriate) has signed and dated a specific informed&#xD;
             consent form&#xD;
&#xD;
          -  The subject is over the age of 18&#xD;
&#xD;
          -  The subject is able to comply with the protocol-defined preoperative procedures, the&#xD;
             postoperative clinical and radiographic evaluations and the recommended rehabilitation&#xD;
             regimen as determined by the investigator&#xD;
&#xD;
          -  The subject has a diagnosis of an MRI or arthroscopically confirmed irreparable medial&#xD;
             meniscus defect&#xD;
&#xD;
          -  The meniscal defect should represent 25% or more of the meniscus and be amenable to&#xD;
             repair&#xD;
&#xD;
          -  The peripheral meniscal rim must be present&#xD;
&#xD;
          -  The subject has a functionally intact anterior cruciate ligament&#xD;
&#xD;
          -  Haemoglobin &gt;9g/dL and platelet count &gt;100,000/mm3 prior to Day 1&#xD;
&#xD;
          -  No contraindication to general anaesthetic&#xD;
&#xD;
          -  Female subjects of child-bearing potential: a negative urine pregnancy test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has a functionally deficient anterior cruciate ligament&#xD;
&#xD;
          -  The subject has concomitant posterior cruciate ligament insufficiency of the involved&#xD;
             knee or a concomitant injury that interferes with the subject's ability to comply with&#xD;
             the recommended rehabilitation program&#xD;
&#xD;
          -  The subject has a diagnosis of untreatable Grade IV Outerbridge Scale degenerative&#xD;
             cartilage disease in the involved knee joint&#xD;
&#xD;
          -  Patients demonstrating an active local or systemic infection&#xD;
&#xD;
          -  Any condition, which in the judgment of the Investigator would preclude adequate&#xD;
             evaluation of the FibroFix™ Meniscus scaffold and clinical outcome.&#xD;
&#xD;
          -  The subject has a history of confirmed anaphylactoid reaction&#xD;
&#xD;
          -  The subject has received local administration of any type of corticosteroid or&#xD;
             systemic administration of antineoplastic, immunostimulating, or immunosuppressive&#xD;
             agents within 180 days prior to the scheduled surgery&#xD;
&#xD;
          -  The subject has evidence of osteonecrosis of the involved knee&#xD;
&#xD;
          -  The subject has a medical history that includes a confirmed diagnosis of rheumatoid or&#xD;
             inflammatory arthritis, or relapsing polychondritis&#xD;
&#xD;
          -  If female and of child-bearing potential: evidence of a positive pregnancy test or a&#xD;
             stated intention to become pregnant in the next 6-12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashley Blom, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bristol</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>medial</keyword>
  <keyword>meniscus</keyword>
  <keyword>scaffold</keyword>
  <keyword>repair</keyword>
  <keyword>tear</keyword>
  <keyword>injury</keyword>
  <!-- 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/NCT02205645
org study id: ORX/2014/FM01
nct id: NCT02205645
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold
The safety of the FibroFix™ Meniscus scaffold will be evaluated in 10 patients scheduled for
      elective arthroscopic medial meniscus partial resection or treatment of asymptomatic medial
      meniscal defect
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: 12 months
description: Number of participants with Adverse Events
measure: Safety
time frame: 7 years
description: Number of participants with Adverse Events
measure: Functional assessment
time frame: 7 years
description: Assessments will be made using recognized and validated tools: Tegner Index, Lysholm Score, International Knee Documentation Committee (IKDC) Score and range of motion of knee
measure: Pain scores
time frame: 12m
description: Assessments will be made using recognized and validated tools: Tegner index, Lysholm score, International Knee Documentation Committee (IKDC) score, VAS scale
measure: Functional assessment
time frame: 12m
description: Assessments will be made using recognized and validated tools: Tegner Index, Lysholm Score, International Knee Documentation Committee (IKDC) score and range of motion of knee
measure: Post operative infection
time frame: 12m
description: Diagnosis of infection will be made on clinical grounds. If infection is diagnosed, a confirmatory bacterial culture will be collected and analysed locally. Assessment will include the patient, tissues around the wound and the wound itself.
arm group label: FibroFix™ Meniscus scaffold
arm group type: Experimental
description: The test article for this study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus. It is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.
intervention type: Device
intervention name: FibroFix™ Meniscus scaffold
description: The test article for this study is the FibroFix™ Meniscus scaffold supplied by Orthox Ltd. The FibroFix™ Meniscus scaffold has been developed for repair of defects of the meniscus.
The FibroFix™ Meniscus scaffold used in this study is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.
arm group label: FibroFix™ Meniscus scaffold
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ashley Blom, Professor
role: Principal Investigator
affiliation: University of Bristol
facility: 
country: United Kingdom
responsible party type: Sponsor