<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/NCT02196818</url>
  </required_header>
  <id_info>
    <org_study_id>P01.014.08/00</org_study_id>
    <nct_id>NCT02196818</nct_id>
  </id_info>
  <brief_title>A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup</brief_title>
  <official_title>A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty</official_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 multi-centre, prospective post marketing surveillance study to assess mid-term&#xD;
      performance of the Mpact cup in subjects requiring primary total hip arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was closed mainly because the surgeons participating no longer had the infrastructure to&#xD;
    support the research and weren't following their subjects&#xD;
  </why_stopped>
  <start_date type="Actual">March 2013</start_date>
  <completion_date type="Actual">April 2022</completion_date>
  <primary_completion_date type="Actual">April 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Kaplan-Meier analysis as a measure of implant performance.</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Harris Hip Score.</measure>
    <time_frame>pre-op, 3/6 months, 1,2 and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological analysis as a meausure of safety.</measure>
    <time_frame>3/6 months, 1,2 and 5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>Arthritis</condition>
  <condition>Avascular Necrosis</condition>
  <condition>Fracture of the Femoral Neck or Head</condition>
  <condition>Congenital Hip Dysplasia</condition>
  <arm_group>
    <arm_group_label>Mpact Acetabular Shell</arm_group_label>
    <description>Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mpact Acetabular Shell</intervention_name>
    <description>Total Hip Replacement</description>
    <arm_group_label>Mpact Acetabular Shell</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        primary total hip arthroplasty&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are willing and able to provide written informed consent for&#xD;
             participation in the study. Written informed consent must be obtained prior to the&#xD;
             patient's surgery.&#xD;
&#xD;
          -  Those presenting with disease that meets the indications for use for Medacta USA&#xD;
             implants defined by this study (on-label use).&#xD;
&#xD;
          -  Patients must be willing to comply with the pre and post-operative evaluation&#xD;
             schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with one or more medical conditions identified as a contraindication defined by&#xD;
             the labeling on any Medacta implants used in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vail Orthopedics, P.C.</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Regional Medical Center</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Bone &amp; Joint Institute, LLC</name>
      <address>
        <city>Libertyville</city>
        <state>Illinois</state>
        <zip>60048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jordan Valley Medical Center</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>March 20, 2023</last_update_submitted>
  <last_update_submitted_qc>March 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</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>Hip Dislocation</mesh_term>
    <mesh_term>Developmental Dysplasia of the Hip</mesh_term>
    <mesh_term>Hip Dislocation, Congenital</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/NCT02196818
org study id: P01.014.08/00
nct id: NCT02196818
lead sponsor: 
This is a multi-centre, prospective post marketing surveillance study to assess mid-term
      performance of the Mpact cup in subjects requiring primary total hip arthroplasty.
observational model: Cohort
time perspective: Prospective
measure: The Kaplan-Meier analysis as a measure of implant performance.
time frame: 5 years
measure: The Harris Hip Score.
time frame: pre-op, 3/6 months, 1,2 and 5 years
measure: Radiological analysis as a meausure of safety.
time frame: 3/6 months, 1,2 and 5 years
arm group label: Mpact Acetabular Shell
description: Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.
intervention type: Device
intervention name: Mpact Acetabular Shell
description: Total Hip Replacement
arm group label: Mpact Acetabular Shell
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hip Dislocation
mesh term: Developmental Dysplasia of the Hip
mesh term: Hip Dislocation, Congenital
mesh term: Necrosis