<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/NCT02239783</url>
  </required_header>
  <id_info>
    <org_study_id>12-LJH-002I</org_study_id>
    <nct_id>NCT02239783</nct_id>
  </id_info>
  <brief_title>Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems</brief_title>
  <official_title>Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MicroPort Orthopedics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MicroPort Orthopedics Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety&#xD;
      and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These&#xD;
      types of studies are required by regulatory authorities for all THA devices that do not have&#xD;
      clinical evidence available at the time of gaining approval to market in the EU. This study&#xD;
      has been designed in accordance with MEDDEV 2.12/2 rev 2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total hip arthroplasty (THA) has been performed since the early 1920s and is generally&#xD;
      considered to be one of the most successful orthopedic surgeries performed. The 8th Annual&#xD;
      Report from the National Joint Registry of England and Wales reported 95.3% component&#xD;
      survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO)&#xD;
      currently markets several THA components throughout the world, including the European Union&#xD;
      (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this&#xD;
      post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA&#xD;
      components. The objectives of this study are to evaluate component survivorship and total&#xD;
      functional outcome scores of implanted subjects at out to 10 years follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Anticipated">November 2028</completion_date>
  <primary_completion_date type="Anticipated">November 2027</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>Component Survivorship</measure>
    <time_frame>10 years post-operative</time_frame>
    <description>The primary objective of this study is to estimate component survivorship of all components out to 10 years follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient functional outcomes</measure>
    <time_frame>Screening (First Available), 2-5 years, 5-7 years, and 10 years</time_frame>
    <description>The secondary objective is to characterize total functional scores, as assessed by HOOS scores and EQ-5D-3L scores.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">143</enrollment>
  <condition>Joint Disease</condition>
  <arm_group>
    <arm_group_label>Total Hip Arthroplasty</arm_group_label>
    <description>Single group previously implanted with the following combination of components: PROFEMUR® TL modular femoral stem, MicroPort Orthopedics acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>total hip arthroplasty implant</intervention_name>
    <arm_group_label>Total Hip Arthroplasty</arm_group_label>
    <other_name>PROFEMUR® TL modular femoral stem</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have been previously implanted with a primary PROFEMUR® TL Modular Femoral&#xD;
        Stem&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has undergone primary THA for any of the following:&#xD;
&#xD;
          -  Non-inflammatory degenerative joint disease such as osteoarthritis, avascular&#xD;
             necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;&#xD;
&#xD;
          -  Inflammatory degenerative joint disease such as rheumatoid arthritis; or&#xD;
&#xD;
          -  Correction of functional deformity&#xD;
&#xD;
          -  Subject is implanted with the specified combination of components&#xD;
&#xD;
          -  Subject is willing and able to complete required study visits or assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects implanted with DYNASTY® BIOFOAM® Acetabular Shells&#xD;
&#xD;
          -  Subjects implanted with a metal-on-metal articulation&#xD;
&#xD;
          -  Subjects implanted with non-MicroPort Orthopedics components (femoral heads,&#xD;
             acetabular shells, acetabular liners) in the enrolled THA&#xD;
&#xD;
          -  Subjects skeletally immature (less than 21 years of age) at time of primary THA&#xD;
             surgery&#xD;
&#xD;
          -  Subjects currently enrolled in another clinical study which could affect the endpoints&#xD;
             of this protocol&#xD;
&#xD;
          -  Subjects unwilling to sign the Informed Consent document&#xD;
&#xD;
          -  Subjects with substance abuse issues&#xD;
&#xD;
          -  Subjects who are incarcerated or have pending incarceration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Beaule, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H-8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <keyword>avascular necrosis</keyword>
  <keyword>ankylosis</keyword>
  <keyword>protrusio acetabuli</keyword>
  <keyword>painful hip dysplasia</keyword>
  <keyword>rheumatoid arthritis</keyword>
  <keyword>correction of functional deformity</keyword>
  <keyword>revision procedures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</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/NCT02239783
org study id: 12-LJH-002I
nct id: NCT02239783
lead sponsor: 
has dmc: No
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety
      and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These
      types of studies are required by regulatory authorities for all THA devices that do not have
      clinical evidence available at the time of gaining approval to market in the EU. This study
      has been designed in accordance with MEDDEV 2.12/2 rev 2.
Total hip arthroplasty (THA) has been performed since the early 1920s and is generally
      considered to be one of the most successful orthopedic surgeries performed. The 8th Annual
      Report from the National Joint Registry of England and Wales reported 95.3% component
      survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO)
      currently markets several THA components throughout the world, including the European Union
      (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this
      post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA
      components. The objectives of this study are to evaluate component survivorship and total
      functional outcome scores of implanted subjects at out to 10 years follow-up.
observational model: Cohort
time perspective: Prospective
measure: Component Survivorship
time frame: 10 years post-operative
description: The primary objective of this study is to estimate component survivorship of all components out to 10 years follow-up.
measure: Patient functional outcomes
time frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years
description: The secondary objective is to characterize total functional scores, as assessed by HOOS scores and EQ-5D-3L scores.
arm group label: Total Hip Arthroplasty
description: Single group previously implanted with the following combination of components: PROFEMUR® TL modular femoral stem, MicroPort Orthopedics acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head.
intervention type: Device
intervention name: total hip arthroplasty implant
arm group label: Total Hip Arthroplasty
other name: PROFEMUR® TL modular femoral stem
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Beaule, MD
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Joint Diseases