<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/NCT03826108</url>
  </required_header>
  <id_info>
    <org_study_id>FIS-MET-2019-01</org_study_id>
    <nct_id>NCT03826108</nct_id>
  </id_info>
  <brief_title>ARTHR-IS (Arthroplasties' Infections Due to Staphylococcus Aureus)</brief_title>
  <official_title>Retrospective Study to Identify the Incidence, Risk Factors and Outcomes of Prosthetic Joint Infection Due to Staphylococcus Aureus After Primary Knee or Hip Joint Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Pública Andaluza para la gestión de la Investigación en Sevilla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario Virgen Macarena</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación Pública Andaluza para la gestión de la Investigación en Sevilla</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 number of arthroplasties is expected to grow in the next few years. Staphylococcus aureus&#xD;
      (SA) is a primary cause of prosthetic joint infection (PJI) with serious consequences. This&#xD;
      microorganism is frequently associated with treatment failure, hospitalizations and need of&#xD;
      prosthesis removal, leading to an important morbidity and an increase in healthcare costs.&#xD;
&#xD;
      ARTHR-IS is a retrospective multi-center study which aims to estimate the burden of SA-PJI&#xD;
      after a hip or knee arthroplasty and their risk factors. Other objectives are to quantify the&#xD;
      costs, the number of hospitalizations and the surgical procedures needed to treat and control&#xD;
      the infection and finally the factors influencing therapeutic failure.&#xD;
&#xD;
      Through a case-control design, ARTHR-IS will group 20 hospitals across 5 European countries&#xD;
      in order to include 150 cases and 450 controls.&#xD;
&#xD;
      The results of this study will provide critical information to develop strategies to prevent&#xD;
      and treat SA-PJI and reduce treatment failures. Also, the results from ARTH-IS study will&#xD;
      help in the design of future clinical trials in prosthesis infections by providing reliable&#xD;
      estimates on the incidence of SA-PJI and the subsequent burden on health care services.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 16, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of the first SA-PJI after a primary joint arthroplasty</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of medical events after SA-PJI</measure>
    <time_frame>18 months</time_frame>
    <description>Events to be traced after the SA-PJI infection are:&#xD;
Hospital readmission&#xD;
Total hospitalization days&#xD;
Joint surgical procedures (debridement, removal and replacement of joint prosthesis)&#xD;
All cause and SA-PJI related mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical or microbiological failure after the SA-PJI</measure>
    <time_frame>18 months</time_frame>
    <description>Clinical failure will be considered to be present if the patient died due to complications related to SA-PJI or if any of the following will be present by the end of the 18 months follow up period after the diagnosis of the first SA-PJI: joint pain or swelling causing an impaired functionality; persistent sinus tract; need for antibiotic treatment for PJI, arthrodesis or amputation. Microbiological failure is defined as any isolation of SA from the joint, periarticular tissues or the blood that was not resolved by the end of the 18th month after the diagnosis of the first SA-PJI.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Staphylococcus Aureus</condition>
  <condition>Prosthetic Joint Infection</condition>
  <condition>Arthroplasty Complications</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Patient who underwent a primary hip (total or partial) or knee arthroplasty and developed a PJI that was culture-confirmed for SA during the first year after the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Patient who underwent a primary hip or knee arthroplasty and did not develop any type of PJI during the first year after the procedure.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Recruitment of cases: the cases will be detected by chart review of all patients who&#xD;
        underwent a primary arthroplasty and matching the list with microbiological records for&#xD;
        SA-PJI infections or discharged records of patients admitted for PJI or any joint&#xD;
        procedure.&#xD;
&#xD;
        Recruitment of controls: for each case, the list of patients who underwent a primary&#xD;
        arthroplasty in the following week and in the same joint as the case will be reviewed, the&#xD;
        first three patients without evidence of PJI during one year will be selected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent a primary hip or knee arthroplasty between 2013 and 2016.&#xD;
&#xD;
          -  Diagnosis of SA -PJI in the first 12 months after primary arthroplasty.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients with a previous SA infection or prosthesis revision on the index joint (joint&#xD;
        which was replaced during arthroplasty).&#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>Reinaldo Espindola, MD</last_name>
    <phone>0034650107427</phone>
    <email>reinaldoespindola@outlook.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria Dolores del Toro, MD</last_name>
    <phone>0034653937488</phone>
    <email>mdeltoro@us.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucía</state>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jesús Rodríguez Baño</last_name>
      <phone>955 00 80 00</phone>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.</citation>
    <PMID>17403800</PMID>
  </reference>
  <reference>
    <citation>Kapadia BH, Banerjee S, Cherian JJ, Bozic KJ, Mont MA. The Economic Impact of Periprosthetic Infections After Total Hip Arthroplasty at a Specialized Tertiary-Care Center. J Arthroplasty. 2016 Jul;31(7):1422-6. doi: 10.1016/j.arth.2016.01.021. Epub 2016 Jan 21.</citation>
    <PMID>26948176</PMID>
  </reference>
  <reference>
    <citation>Del Toro MD, Penas C, Conde-Albarracin A, Palomino J, Brun F, Sanchez S, Rodriguez-Bano J. Development and validation of baseline, perioperative and at-discharge predictive models for postsurgical prosthetic joint infection. Clin Microbiol Infect. 2019 Feb;25(2):196-202. doi: 10.1016/j.cmi.2018.04.023. Epub 2018 Apr 30.</citation>
    <PMID>29715553</PMID>
  </reference>
  <reference>
    <citation>Lora-Tamayo J, Murillo O, Iribarren JA, Soriano A, Sanchez-Somolinos M, Baraia-Etxaburu JM, Rico A, Palomino J, Rodriguez-Pardo D, Horcajada JP, Benito N, Bahamonde A, Granados A, del Toro MD, Cobo J, Riera M, Ramos A, Jover-Saenz A, Ariza J; REIPI Group for the Study of Prosthetic Infection. A large multicenter study of methicillin-susceptible and methicillin-resistant Staphylococcus aureus prosthetic joint infections managed with implant retention. Clin Infect Dis. 2013 Jan;56(2):182-94. doi: 10.1093/cid/cis746. Epub 2012 Aug 31.</citation>
    <PMID>22942204</PMID>
  </reference>
  <reference>
    <citation>Senneville E, Joulie D, Legout L, Valette M, Dezeque H, Beltrand E, Rosele B, d'Escrivan T, Loiez C, Caillaux M, Yazdanpanah Y, Maynou C, Migaud H. Outcome and predictors of treatment failure in total hip/knee prosthetic joint infections due to Staphylococcus aureus. Clin Infect Dis. 2011 Aug;53(4):334-40. doi: 10.1093/cid/cir402.</citation>
    <PMID>21810745</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>August 7, 2019</last_update_submitted>
  <last_update_submitted_qc>August 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2019</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>
    <mesh_term>Staphylococcal Infections</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/NCT03826108
org study id: FIS-MET-2019-01
nct id: NCT03826108
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The number of arthroplasties is expected to grow in the next few years. Staphylococcus aureus
      (SA) is a primary cause of prosthetic joint infection (PJI) with serious consequences. This
      microorganism is frequently associated with treatment failure, hospitalizations and need of
      prosthesis removal, leading to an important morbidity and an increase in healthcare costs.

      ARTHR-IS is a retrospective multi-center study which aims to estimate the burden of SA-PJI
      after a hip or knee arthroplasty and their risk factors. Other objectives are to quantify the
      costs, the number of hospitalizations and the surgical procedures needed to treat and control
      the infection and finally the factors influencing therapeutic failure.

      Through a case-control design, ARTHR-IS will group 20 hospitals across 5 European countries
      in order to include 150 cases and 450 controls.

      The results of this study will provide critical information to develop strategies to prevent
      and treat SA-PJI and reduce treatment failures. Also, the results from ARTH-IS study will
      help in the design of future clinical trials in prosthesis infections by providing reliable
      estimates on the incidence of SA-PJI and the subsequent burden on health care services.
observational model: Case-Control
time perspective: Retrospective
measure: Occurrence of the first SA-PJI after a primary joint arthroplasty
time frame: 1 year
measure: Occurrence of medical events after SA-PJI
time frame: 18 months
description: Events to be traced after the SA-PJI infection are:
Hospital readmission
Total hospitalization days
Joint surgical procedures (debridement, removal and replacement of joint prosthesis)
All cause and SA-PJI related mortality
measure: Clinical or microbiological failure after the SA-PJI
time frame: 18 months
description: Clinical failure will be considered to be present if the patient died due to complications related to SA-PJI or if any of the following will be present by the end of the 18 months follow up period after the diagnosis of the first SA-PJI: joint pain or swelling causing an impaired functionality; persistent sinus tract; need for antibiotic treatment for PJI, arthrodesis or amputation. Microbiological failure is defined as any isolation of SA from the joint, periarticular tissues or the blood that was not resolved by the end of the 18th month after the diagnosis of the first SA-PJI.
arm group label: Cases
description: Patient who underwent a primary hip (total or partial) or knee arthroplasty and developed a PJI that was culture-confirmed for SA during the first year after the procedure.
arm group label: Controls
description: Patient who underwent a primary hip or knee arthroplasty and did not develop any type of PJI during the first year after the procedure.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Reinaldo Espindola, MD
phone: 0034650107427
email: reinaldoespindola@outlook.com
last name: Maria Dolores del Toro, MD
phone: 0034653937488
email: mdeltoro@us.es
facility: 
status: Recruiting
contact: 
country: Spain
citation: Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PMID: 17403800
citation: Kapadia BH, Banerjee S, Cherian JJ, Bozic KJ, Mont MA. The Economic Impact of Periprosthetic Infections After Total Hip Arthroplasty at a Specialized Tertiary-Care Center. J Arthroplasty. 2016 Jul;31(7):1422-6. doi: 10.1016/j.arth.2016.01.021. Epub 2016 Jan 21.
PMID: 26948176
citation: Del Toro MD, Penas C, Conde-Albarracin A, Palomino J, Brun F, Sanchez S, Rodriguez-Bano J. Development and validation of baseline, perioperative and at-discharge predictive models for postsurgical prosthetic joint infection. Clin Microbiol Infect. 2019 Feb;25(2):196-202. doi: 10.1016/j.cmi.2018.04.023. Epub 2018 Apr 30.
PMID: 29715553
citation: Lora-Tamayo J, Murillo O, Iribarren JA, Soriano A, Sanchez-Somolinos M, Baraia-Etxaburu JM, Rico A, Palomino J, Rodriguez-Pardo D, Horcajada JP, Benito N, Bahamonde A, Granados A, del Toro MD, Cobo J, Riera M, Ramos A, Jover-Saenz A, Ariza J; REIPI Group for the Study of Prosthetic Infection. A large multicenter study of methicillin-susceptible and methicillin-resistant Staphylococcus aureus prosthetic joint infections managed with implant retention. Clin Infect Dis. 2013 Jan;56(2):182-94. doi: 10.1093/cid/cis746. Epub 2012 Aug 31.
PMID: 22942204
citation: Senneville E, Joulie D, Legout L, Valette M, Dezeque H, Beltrand E, Rosele B, d'Escrivan T, Loiez C, Caillaux M, Yazdanpanah Y, Maynou C, Migaud H. Outcome and predictors of treatment failure in total hip/knee prosthetic joint infections due to Staphylococcus aureus. Clin Infect Dis. 2011 Aug;53(4):334-40. doi: 10.1093/cid/cir402.
PMID: 21810745
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Staphylococcal Infections
sharing ipd: Undecided