<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/NCT03038464</url>
  </required_header>
  <id_info>
    <org_study_id>445/21</org_study_id>
    <nct_id>NCT03038464</nct_id>
  </id_info>
  <brief_title>Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection</brief_title>
  <acronym>SyPJI</acronym>
  <official_title>Benefit of Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The two-stage protocol is gold standard in terms of infection control treating prosthetic&#xD;
      joint infections of total hip and total knee arthroplasty. The antibiotic pause for&#xD;
      diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of&#xD;
      infection and development of resistant bacterial strains. Serological markers and synovial&#xD;
      analysis are common use to exclude persistence of infection.&#xD;
&#xD;
      The investigators therefore asked 1) is the serological testing of c-reactive protein and&#xD;
      leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of&#xD;
      synovial aspiration of PMMA Spacers on hip and knee joints.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Anticipated">May 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reinfection rate</measure>
    <time_frame>2 years</time_frame>
    <description>Reinfection rate after reimplantation of joint prosthesis</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Diagnosis Prosthetic Joint Infection</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Synovial biopsy</intervention_name>
    <description>Biopsy of jint prior reimplantation of new joint prosthesis</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with periprostheitc joint infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with periprostheitc joint infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reinfection in history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>norbert harrasser</last_name>
    <phone>15232716657</phone>
    <email>norbert.harrasser@gmx.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Klinikum rechts der Isar</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Norbert Harrasser, DR.</last_name>
      <phone>00498941405229</phone>
      <email>norbert.harrasser@gmx.net</email>
    </contact>
    <contact_backup>
      <last_name>Ingo Banke, Dr.</last_name>
      <phone>00498941405284</phone>
      <email>ingo@banke.eu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>April 24, 2017</last_update_submitted>
  <last_update_submitted_qc>April 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Munich</investigator_affiliation>
    <investigator_full_name>Harrasser</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>
    <mesh_term>Arthritis, Infectious</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03038464
org study id: 445/21
nct id: NCT03038464
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The two-stage protocol is gold standard in terms of infection control treating prosthetic
      joint infections of total hip and total knee arthroplasty. The antibiotic pause for
      diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of
      infection and development of resistant bacterial strains. Serological markers and synovial
      analysis are common use to exclude persistence of infection.

      The investigators therefore asked 1) is the serological testing of c-reactive protein and
      leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of
      synovial aspiration of PMMA Spacers on hip and knee joints.
observational model: Cohort
time perspective: Retrospective
measure: Reinfection rate
time frame: 2 years
description: Reinfection rate after reimplantation of joint prosthesis
intervention type: Diagnostic Test
intervention name: Synovial biopsy
description: Biopsy of jint prior reimplantation of new joint prosthesis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: norbert harrasser
phone: 15232716657
email: norbert.harrasser@gmx.net
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Harrasser
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Arthritis, Infectious
sharing ipd: Undecided