<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/NCT04427722</url>
  </required_header>
  <id_info>
    <org_study_id>CSA2019-11K</org_study_id>
    <nct_id>NCT04427722</nct_id>
  </id_info>
  <brief_title>PMCF Study of MPS-Flex® Knee System in TKA</brief_title>
  <official_title>A Multi-Centre Post Market Clinical Follow-Up Study of MPS-Flex® Total Knee Joint Prostheses in Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zimmer Biomet</source>
  <oversight_info>
    <has_dmc>No</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 objective of this study is to obtain implant survivorship and clinical outcomes data for&#xD;
      the commercially available MPS-Flex® Total Knee Joint Prostheses used in primary total knee&#xD;
      arthroplasty (TKA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective and prospective, multi-centre, post-market clinical follow-up study&#xD;
      involving orthopedic surgeons skilled in TKA and experienced implanting the devices included&#xD;
      in this study. Patient demographic and operative information will be collected&#xD;
      retrospectively. Postoperative clinical outcome, radiographic assessment and adverse events&#xD;
      will be collected prospectively starting from the first year of postoperative follow up&#xD;
      visit.&#xD;
&#xD;
      All study subjects have undergone routine preoperative clinical evaluations prior to their&#xD;
      THA, and implanted MPS-Flex® Total Knee Joint Prostheses in accordance to indications and&#xD;
      intended use, and appropriate surgical technique(s) will be invited to participate in the&#xD;
      study at their first year of postoperative follow up visit, and sign ICF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 25, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2032</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2032</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implant survivorship based on revision</measure>
    <time_frame>10 years</time_frame>
    <description>Implant survival will be summarized using a Kaplan-Meier method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional outcome based on Knee Society Score</measure>
    <time_frame>10 years</time_frame>
    <description>The Knee Society Scoring System combines an objective physician-derived component with a subjective patient-derived component that evaluates pain relief, functional abilities, satisfaction, and fulfillment of expectations. It consists of four subscales: (1) Objective Knee Score (seven items; 100 points), (2) Satisfaction Score (five items; 40 points), (3) Expectation Score (three items; 15 points), and (4) Functional Activity Score (19 items; 100 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life based on EQ-5D questionnaire</measure>
    <time_frame>10 years</time_frame>
    <description>EQ-5D is a standardized measure of health-related quality of life states consisting of 5 dimensions, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L version was used in the study. Each dimension has 5 responses recording 5 levels of severity (no problems/slight problems/moderate problems/severe problems or extreme problems). The responses to the EQ-5D dimensions are used to obtain a single EQ-5D index value where 1 represents full health and 0 represents death. The questionnaire also includes a vertical, visual analogue scale (EQ VAS) for the respondents to record their self-rated health where the 2 extreme ends of the scale are labelled as 'Best imaginable health state' and 'Worst imaginable health state' respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessment</measure>
    <time_frame>10 years</time_frame>
    <description>Summarize the category, incidence and frequency of adverse events</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>MPS-Flex Total Knee Joint Prostheses</arm_group_label>
    <description>Patients who have received MPS-Flex Total Knee Joint Prostheses for their primary TKA and meet the Patient Selection Criteria outlined in the study protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MPS-Flex Total Knee Joint Prostheses</intervention_name>
    <description>Patients who have received MPS-Flex Total Knee Joint Prostheses for their primary TKA and meet the Patient Selection Criteria outlined in the study protocol.</description>
    <arm_group_label>MPS-Flex Total Knee Joint Prostheses</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population for primary statistical analysis will consist of patients who have&#xD;
        already underwent their surgery with MPS-Flex® Total Knee Joint Prostheses for their&#xD;
        primary TKA and satisfy eligibility criteria outlined in this section. In order to avoid&#xD;
        potential selection bias, each investigator will offer study participation to each&#xD;
        consecutive eligible patient presenting as a candidate for primary TKA using the MPS-Flex®&#xD;
        Total Knee Joint Prostheses.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A patient must meet the following criteria to be eligible for participation:&#xD;
&#xD;
          -  Age 18 to 75 years old, inclusive.&#xD;
&#xD;
          -  Had a primary unilateral or bilateral (simultaneous or staged)TKA based on physical&#xD;
             exam and medical history, including diagnosis of severe knee pain and disability due&#xD;
             to at least one of the following:&#xD;
&#xD;
               1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.&#xD;
&#xD;
               2. Collagen disorders and/or avascular necrosis of the femoral condyle.&#xD;
&#xD;
               3. Post-traumatic loss of joint configuration, particularly when there is&#xD;
                  patellofemoral erosion, dysfunction or prior patellectomy.&#xD;
&#xD;
               4. Moderate valgus, varus, or flexion deformities.&#xD;
&#xD;
          -  Had received MPS-Flex® Total Knee Joint Prostheses per the approved indications for&#xD;
             use for the TKA.&#xD;
&#xD;
          -  Willing and able to provide written informed consent by signing and dating the EC&#xD;
             approved informed consent form.&#xD;
&#xD;
          -  Willing and able to complete scheduled study procedures and follow-up evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A patient must not meet the following criteria to be eligible for participation:&#xD;
&#xD;
          -  The patient is:&#xD;
&#xD;
               1. A prisoner&#xD;
&#xD;
               2. Mentally incompetent or unable to understand what participation in the study&#xD;
                  entails&#xD;
&#xD;
               3. A known alcohol or drug abuser&#xD;
&#xD;
               4. Anticipated to be non-compliant&#xD;
&#xD;
          -  Meet any of the following contraindications of the product.&#xD;
&#xD;
               1. Had previous infection in the operative knee joint, and/or has systemic&#xD;
                  inflection that could affect prosthesis&#xD;
&#xD;
               2. Insufficient bone stock of tibia or tibia surface&#xD;
&#xD;
               3. Skeleton immaturity&#xD;
&#xD;
               4. Neuropathic arthropathy&#xD;
&#xD;
               5. Osteoporosis, muscle structure or neuromuscular lesions which affects lower limb&#xD;
                  function&#xD;
&#xD;
               6. The affected joint occurs fusion in the satisfactory functional position and form&#xD;
                  stable,&#xD;
&#xD;
               7. A history of rheumatoid arthritis with skin ulcers or recurrent skin damage&#xD;
&#xD;
          -  Has a diagnosed systemic disease that could affect his/her safety or the study&#xD;
             outcome.&#xD;
&#xD;
          -  Known sensitivity or allergic reaction to one or more of the implanted materials.&#xD;
&#xD;
          -  Known local bone tumors and/or cysts in the operative knee&#xD;
&#xD;
          -  Known to be pregnant&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥ 40&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhenzhong Guo, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jizhong Erengy Fengfeng Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lydia Wang</last_name>
    <phone>86-21-2220</phone>
    <phone_ext>6116</phone_ext>
    <email>lydia.wang@zimmerbiomet.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jizhong Erengy Fengfeng Hospital</name>
      <address>
        <city>Handan</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhenzhong Guo, Professor</last_name>
      <phone>19903307878</phone>
      <email>'baobeigsy@163.com'</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>October 7, 2022</last_update_submitted>
  <last_update_submitted_qc>October 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total Knee Arthroplasty</keyword>
  <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/NCT04427722
org study id: CSA2019-11K
nct id: NCT04427722
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to obtain implant survivorship and clinical outcomes data for
      the commercially available MPS-Flex® Total Knee Joint Prostheses used in primary total knee
      arthroplasty (TKA).
This is a retrospective and prospective, multi-centre, post-market clinical follow-up study
      involving orthopedic surgeons skilled in TKA and experienced implanting the devices included
      in this study. Patient demographic and operative information will be collected
      retrospectively. Postoperative clinical outcome, radiographic assessment and adverse events
      will be collected prospectively starting from the first year of postoperative follow up
      visit.

      All study subjects have undergone routine preoperative clinical evaluations prior to their
      THA, and implanted MPS-Flex® Total Knee Joint Prostheses in accordance to indications and
      intended use, and appropriate surgical technique(s) will be invited to participate in the
      study at their first year of postoperative follow up visit, and sign ICF.
observational model: Cohort
time perspective: Cross-Sectional
measure: Implant survivorship based on revision
time frame: 10 years
description: Implant survival will be summarized using a Kaplan-Meier method.
measure: Functional outcome based on Knee Society Score
time frame: 10 years
description: The Knee Society Scoring System combines an objective physician-derived component with a subjective patient-derived component that evaluates pain relief, functional abilities, satisfaction, and fulfillment of expectations. It consists of four subscales: (1) Objective Knee Score (seven items; 100 points), (2) Satisfaction Score (five items; 40 points), (3) Expectation Score (three items; 15 points), and (4) Functional Activity Score (19 items; 100 points).
measure: Quality of life based on EQ-5D questionnaire
time frame: 10 years
description: EQ-5D is a standardized measure of health-related quality of life states consisting of 5 dimensions, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L version was used in the study. Each dimension has 5 responses recording 5 levels of severity (no problems/slight problems/moderate problems/severe problems or extreme problems). The responses to the EQ-5D dimensions are used to obtain a single EQ-5D index value where 1 represents full health and 0 represents death. The questionnaire also includes a vertical, visual analogue scale (EQ VAS) for the respondents to record their self-rated health where the 2 extreme ends of the scale are labelled as 'Best imaginable health state' and 'Worst imaginable health state' respectively.
measure: Safety assessment
time frame: 10 years
description: Summarize the category, incidence and frequency of adverse events
arm group label: MPS-Flex Total Knee Joint Prostheses
description: Patients who have received MPS-Flex Total Knee Joint Prostheses for their primary TKA and meet the Patient Selection Criteria outlined in the study protocol.
intervention type: Device
intervention name: MPS-Flex Total Knee Joint Prostheses
description: Patients who have received MPS-Flex Total Knee Joint Prostheses for their primary TKA and meet the Patient Selection Criteria outlined in the study protocol.
arm group label: MPS-Flex Total Knee Joint Prostheses
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Zhenzhong Guo, Professor
role: Principal Investigator
affiliation: Jizhong Erengy Fengfeng Hospital
last name: Lydia Wang
phone: 86-21-2220
phone ext: 6116
email: lydia.wang@zimmerbiomet.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: No