<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/NCT01712880</url>
  </required_header>
  <id_info>
    <org_study_id>12055</org_study_id>
    <nct_id>NCT01712880</nct_id>
  </id_info>
  <brief_title>Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections</brief_title>
  <official_title>The Treatment of the Acute Periprosthetic Hip Infection After Uncemented Total Hip Arthroplasty: A Randomized Study Comparing Open Debridement Component Retention (ODCR) With Modular Exchange Versus One Stage Exchange Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OrthoCarolina Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Midwest Orthopaedics at Rush</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OrthoCarolina Research Institute, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the success rate of two treatments for infection&#xD;
      after total hip replacement: single stage arthroplasty exchange (your surgeon will take out&#xD;
      your original implants and replace them with a complete new set) compared to irrigation and&#xD;
      debridement with modular exchange (your surgeon will clean your implants with a surgical&#xD;
      solution and take out the plastic liner and replace it with a new one - the rest of your hip&#xD;
      implants will stay in place). The goal is to see if one is better than the other for the&#xD;
      treatment of hip infection after a total hip replacement. A successful treatment means that&#xD;
      you did not have to have another surgery on your hip for an infection-related reason.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study was not feasible.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success</measure>
    <time_frame>2 year</time_frame>
    <description>Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Periprosthetic Infection Total Hip Arthoplasty</condition>
  <arm_group>
    <arm_group_label>open debridement with modular exchange</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>one stage exchange</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>open debridement with modular exchange</intervention_name>
    <arm_group_label>open debridement with modular exchange</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>one stage exchange</intervention_name>
    <arm_group_label>one stage exchange</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Return to the OR for a drainage procedure within six weeks of index primary uncemented&#xD;
             arthroplasty 1a) Exam findings within six weeks of index operation:&#xD;
&#xD;
               -  Drainage for more than 7 days&#xD;
&#xD;
               -  Wound appearance consistent with deep infection or hematoma&#xD;
&#xD;
               -  Persistent fever or evidence of bacteremia&#xD;
&#xD;
               -  All patients currently deemed appropriate for irrigation and debridement&#xD;
&#xD;
          2. Labs&#xD;
&#xD;
             - Rising inflammatory seromarkers&#xD;
&#xD;
          3. Aspiration with a positive culture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous history of periprosthetic infection&#xD;
&#xD;
          2. Prisoners&#xD;
&#xD;
          3. Patients not willing to consent for the proposed treatment&#xD;
&#xD;
          4. Patients with altered mental status&#xD;
&#xD;
          5. Concurrent metastatic infection&#xD;
&#xD;
          6. Superficial Infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>OrthoCarolina Research Institue</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>November 5, 2013</last_update_submitted>
  <last_update_submitted_qc>November 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2013</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>Infections</mesh_term>
    <mesh_term>Communicable 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/NCT01712880
org study id: 12055
nct id: NCT01712880
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine the success rate of two treatments for infection
      after total hip replacement: single stage arthroplasty exchange (your surgeon will take out
      your original implants and replace them with a complete new set) compared to irrigation and
      debridement with modular exchange (your surgeon will clean your implants with a surgical
      solution and take out the plastic liner and replace it with a new one - the rest of your hip
      implants will stay in place). The goal is to see if one is better than the other for the
      treatment of hip infection after a total hip replacement. A successful treatment means that
      you did not have to have another surgery on your hip for an infection-related reason.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success
time frame: 2 year
description: Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection
arm group label: open debridement with modular exchange
arm group type: Active Comparator
arm group label: one stage exchange
arm group type: Active Comparator
intervention type: Procedure
intervention name: open debridement with modular exchange
arm group label: open debridement with modular exchange
intervention type: Procedure
intervention name: one stage exchange
arm group label: one stage exchange
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases