<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/NCT02188199</url>
  </required_header>
  <id_info>
    <org_study_id>C3 1001</org_study_id>
    <nct_id>NCT02188199</nct_id>
  </id_info>
  <brief_title>C3 Total Joint Patient Registry</brief_title>
  <official_title>Clinical Care Continuum (C3) Total Joint Patient Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DC2 Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinical Care Continuum (C3) Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Research Independent Operations Management</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>DC2 Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the efficacy of products, implants, and procedures for knee and hip&#xD;
      replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This registry will prospectively collect a core set of data on patients undergoing knee or&#xD;
      hip replacement. This registry will include a variety of different products, implants,&#xD;
      technologies and procedures. The registry will also collect any adverse events/complications&#xD;
      that occur during or following these surgeries. This database can also be utilized in the&#xD;
      future to answer research questions, by retrospectively going back through the data. This&#xD;
      information also may go to insurance companies or hospitals for quality measurement and&#xD;
      metrics reporting. The data will be utilized to develop strategic treatment pathways that&#xD;
      will improve patient care. Ultimately, the goal of the registry is to enhance the&#xD;
      understanding of treatment associated with knee and hip replacement and the resulting patient&#xD;
      outcomes. The registry will also be used to provide quality measurement and metrics&#xD;
      reporting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>Assessment of hip symptoms and disability to be taken at baseline and 3 months after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 6 months</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Assessment of hip symptoms and disability to be taken at baseline and 6 months after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 1 year</measure>
    <time_frame>baseline and 1 year</time_frame>
    <description>Assessment of hip symptoms and disability to be taken at baseline and 1 year after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 3 months</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>Assessment of knee symptoms and disability to be taken at baseline and 3 months after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 1 year</measure>
    <time_frame>baseline and 1 year</time_frame>
    <description>Assessment of knee symptoms and disability to be taken at baseline and 1 year after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 6 months</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Assessment of knee symptoms and disability to be taken at baseline and 6 months after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events at time of surgery</measure>
    <time_frame>Time of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events at 6 weeks after surgery</measure>
    <time_frame>6 weeks after surgery</time_frame>
    <description>within 6 weeks but not less than 1 week after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events at 3 months after surgery</measure>
    <time_frame>3 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events at 6 months after surgery</measure>
    <time_frame>6 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events at 1 year after surgery</measure>
    <time_frame>1 year after surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Knee Replacement</condition>
  <condition>Hip Replacement</condition>
  <arm_group>
    <arm_group_label>Knee Replacement</arm_group_label>
    <description>Patients undergoing knee replacement surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hip Replacement</arm_group_label>
    <description>Patients undergoing hip replacement</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will come from cohorts of patients undergoing either knee or hip&#xD;
        replacement in accordance with a nationwide multicenter observational study design.&#xD;
        Eligibility criteria require only that patients are undergoing knee or hip replacement, are&#xD;
        able to sign informed consent and are 18 years of age or older. Approximately 10,000&#xD;
        patients will be enrolled&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Undergoing knee or hip replacement&#xD;
&#xD;
          -  Subject is likely to follow standard of care post-operative follow up for at least 1&#xD;
             year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to complete follow-up visits or required questionnaires&#xD;
&#xD;
          -  Inability to provide informed consent without a legally authorized representative&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Christina R Cook, PhD</last_name>
    <phone>615-712-9574</phone>
    <email>ccook@dc2healthcare.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Risa Tyo, PharmD</last_name>
    <phone>615-712-9574</phone>
    <email>rtyo@dc2healthcare.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>DC2 Healthcare</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina R Cook, PhD</last_name>
      <phone>615-712-9574</phone>
      <email>ccook@dc2healthcare.com</email>
    </contact>
    <contact_backup>
      <last_name>Risa Tyo, PharmD</last_name>
      <phone>615-712-9574</phone>
      <email>rtyo@dc2healthcare.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.dc2healthcare.com</url>
    <description>DC2 Healthcare</description>
  </link>
  <link>
    <url>http://www.nriom.com/</url>
    <description>NRIOM</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hip</keyword>
  <keyword>Knee</keyword>
  <keyword>Hip replacement</keyword>
  <keyword>Knee replacement</keyword>
  <keyword>Total Joint</keyword>
  <!-- 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/NCT02188199
org study id: C3 1001
nct id: NCT02188199
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study will assess the efficacy of products, implants, and procedures for knee and hip
      replacement.
This registry will prospectively collect a core set of data on patients undergoing knee or
      hip replacement. This registry will include a variety of different products, implants,
      technologies and procedures. The registry will also collect any adverse events/complications
      that occur during or following these surgeries. This database can also be utilized in the
      future to answer research questions, by retrospectively going back through the data. This
      information also may go to insurance companies or hospitals for quality measurement and
      metrics reporting. The data will be utilized to develop strategic treatment pathways that
      will improve patient care. Ultimately, the goal of the registry is to enhance the
      understanding of treatment associated with knee and hip replacement and the resulting patient
      outcomes. The registry will also be used to provide quality measurement and metrics
      reporting.
observational model: Cohort
time perspective: Prospective
measure: Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months
time frame: baseline and 3 months
description: Assessment of hip symptoms and disability to be taken at baseline and 3 months after surgery
measure: Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 6 months
time frame: baseline and 6 months
description: Assessment of hip symptoms and disability to be taken at baseline and 6 months after surgery
measure: Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 1 year
time frame: baseline and 1 year
description: Assessment of hip symptoms and disability to be taken at baseline and 1 year after surgery
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 3 months
time frame: baseline and 3 months
description: Assessment of knee symptoms and disability to be taken at baseline and 3 months after surgery
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 1 year
time frame: baseline and 1 year
description: Assessment of knee symptoms and disability to be taken at baseline and 1 year after surgery
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 6 months
time frame: baseline and 6 months
description: Assessment of knee symptoms and disability to be taken at baseline and 6 months after surgery
measure: Adverse Events at time of surgery
time frame: Time of surgery
measure: Adverse Events at 6 weeks after surgery
time frame: 6 weeks after surgery
description: within 6 weeks but not less than 1 week after surgery
measure: Adverse Events at 3 months after surgery
time frame: 3 months after surgery
measure: Adverse Events at 6 months after surgery
time frame: 6 months after surgery
measure: Adverse Events at 1 year after surgery
time frame: 1 year after surgery
arm group label: Knee Replacement
description: Patients undergoing knee replacement surgery
arm group label: Hip Replacement
description: Patients undergoing hip replacement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christina R Cook, PhD
phone: 615-712-9574
email: ccook@dc2healthcare.com
last name: Risa Tyo, PharmD
phone: 615-712-9574
email: rtyo@dc2healthcare.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
url: http://www.dc2healthcare.com
description: DC2 Healthcare
url: http://www.nriom.com/
description: NRIOM
responsible party type: Sponsor