<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/NCT02199600</url>
  </required_header>
  <id_info>
    <org_study_id>P02.014.01</org_study_id>
    <nct_id>NCT02199600</nct_id>
  </id_info>
  <brief_title>The Medacta International GMK Sphere Post-Marketing Surveillance Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medacta International SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medacta International SA</source>
  <brief_summary>
    <textblock>
      This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Anticipated">April 2029</completion_date>
  <primary_completion_date type="Actual">October 2019</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>Assessment of the clinical outcome following total knee replacement using the Knee Society Score.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The OXFORD score as a measure of implant functionality.</measure>
    <time_frame>pre-op, 6 months and annually for 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of implant survivorship as a measure of safety and tolerability.</measure>
    <time_frame>6 weeks, 6 months, 3, 5, 7 and 10 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic analysis</measure>
    <time_frame>pre-op, 6 months, 3, 5,7 and 10 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The EuroQol score as a measure of patient' quality of life.</measure>
    <time_frame>pre-op, 6 months, 3, 5,7 and 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the clinical outcome following total knee replacement using the Knee Society Score</measure>
    <time_frame>pre-op, at 6 months, at 3, 5, 7 and 10 years.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Arthritis</condition>
  <condition>Traumatic Arthritis</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Poly-arthritis</condition>
  <condition>Avascular Necrosis</condition>
  <arm_group>
    <arm_group_label>GMK Sphere Knee Replacement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients who comply with the protocol and received GMK Sphere component.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GMK Sphere Knee Replacement</intervention_name>
    <arm_group_label>GMK Sphere Knee Replacement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A disabled or severely disabled joint as a result of arthritis, traumatic arthritis,&#xD;
             rheumatoid arthritis, poly-arthritis or avascular necrosis&#xD;
&#xD;
          -  Patients must be between the age of 18 and 80 at the time of consent&#xD;
&#xD;
          -  Listed for total knee replacement surgery.&#xD;
&#xD;
          -  Patients who are willing to give informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Progressive local or systemic infection&#xD;
&#xD;
          -  Muscular loss, neuromuscular disease or vascular deficiency of the affected limb,&#xD;
             making the operation unjustifiable&#xD;
&#xD;
          -  Severe instability secondary to advance destruction of condylar structures or loss of&#xD;
             integrity of the medial or lateral ligament&#xD;
&#xD;
          -  Any patient who cannot or will not provide informed consent for participation in the&#xD;
             study&#xD;
&#xD;
          -  Those whose prospects for a recovery to independent mobility would be compromised by&#xD;
             known coexistent, medical problems&#xD;
&#xD;
          -  Patient whose BMI exceeds 40&#xD;
&#xD;
          -  Any case not described in the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AZ Maria Middelares</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal London Hospital</name>
      <address>
        <city>Whitechapel</city>
        <state>London</state>
        <zip>E11BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal National Orthopaedic Hospital NHS Trust</name>
      <address>
        <city>Stanmore</city>
        <state>Middlesex</state>
        <zip>HA74LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Elective Orthopaedic Centre (EOC)</name>
      <address>
        <city>Epsom</city>
        <state>Surrey</state>
        <zip>KT18 7EG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</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>Arthritis</mesh_term>
    <mesh_term>Necrosis</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/NCT02199600
org study id: P02.014.01
nct id: NCT02199600
lead sponsor: 
This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of the clinical outcome following total knee replacement using the Knee Society Score.
time frame: 6 months
measure: The OXFORD score as a measure of implant functionality.
time frame: pre-op, 6 months and annually for 10 years
measure: Assessment of implant survivorship as a measure of safety and tolerability.
time frame: 6 weeks, 6 months, 3, 5, 7 and 10 years.
measure: Radiographic analysis
time frame: pre-op, 6 months, 3, 5,7 and 10 years.
measure: The EuroQol score as a measure of patient' quality of life.
time frame: pre-op, 6 months, 3, 5,7 and 10 years
measure: Assessment of the clinical outcome following total knee replacement using the Knee Society Score
time frame: pre-op, at 6 months, at 3, 5, 7 and 10 years.
arm group label: GMK Sphere Knee Replacement
arm group type: Other
description: Patients who comply with the protocol and received GMK Sphere component.
intervention type: Device
intervention name: GMK Sphere Knee Replacement
arm group label: GMK Sphere Knee Replacement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: United Kingdom
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Necrosis