<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/NCT03233620</url>
  </required_header>
  <id_info>
    <org_study_id>R11178</org_study_id>
    <nct_id>NCT03233620</nct_id>
  </id_info>
  <brief_title>Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients</brief_title>
  <official_title>Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients: a Prospective Study With 2-year Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coxa, Hospital for Joint Replacement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coxa, Hospital for Joint Replacement</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study was to assess the effectiveness of contemporary knee arthroplasty in&#xD;
      working-age patients (&lt; 65 years) by conducting a prospective cohort study with 2-year follow&#xD;
      up. Outcomes were measured comprehensively using various patient-reported outcome measures&#xD;
      (PROMs) to provide information on the effect of knee arthroplasty on pain, satisfaction,&#xD;
      physical activity, activities of daily living, and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2012</start_date>
  <completion_date type="Actual">November 1, 2016</completion_date>
  <primary_completion_date type="Actual">October 30, 2014</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>Effectiveness of contemporary knee arthroplasty in working-age patients</measure>
    <time_frame>2 years</time_frame>
    <description>PROMs</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>working age patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Prospective cohort of 250 patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Knee arthroplasty</intervention_name>
    <description>Effectiveness of knee arthroplasty surgery.</description>
    <arm_group_label>working age patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65 or less and&#xD;
&#xD;
          -  Scheduled for either TKA or unicondylar knee arthroplasty (UKA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  rheumatoid arthritis or other inflammatory diseases&#xD;
&#xD;
          -  unwilling to provide informed consent&#xD;
&#xD;
          -  physical, mental, or neurological conditions that could comprise the patient´s ability&#xD;
             and compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol&#xD;
             abuse, serious mental illness, general neurological conditions such as Parkinson's&#xD;
             disease, multiple sclerosis (MS), etc.)&#xD;
&#xD;
          -  known sensitivity to materials in the devices.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee arthroplasty</keyword>
  <keyword>working-age</keyword>
  <keyword>patient related outcome measures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <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/NCT03233620
org study id: R11178
nct id: NCT03233620
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of our study was to assess the effectiveness of contemporary knee arthroplasty in
      working-age patients (< 65 years) by conducting a prospective cohort study with 2-year follow
      up. Outcomes were measured comprehensively using various patient-reported outcome measures
      (PROMs) to provide information on the effect of knee arthroplasty on pain, satisfaction,
      physical activity, activities of daily living, and quality of life.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of contemporary knee arthroplasty in working-age patients
time frame: 2 years
description: PROMs
arm group label: working age patients
arm group type: Other
description: Prospective cohort of 250 patients.
intervention type: Other
intervention name: Knee arthroplasty
description: Effectiveness of knee arthroplasty surgery.
arm group label: working age patients
criteria: 
gender: All
minimum age: N/A
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No