ARTHR-IS (Arthroplasties' Infections Due to Staphylococcus Aureus)

August 7, 2019 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Maria Dolores del Toro, MD
  • Phone Number: 0034653937488
  • Email: mdeltoro@us.es

Study Locations

  • Spain
    • Andalucía
      • Sevilla, Andalucía, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Jesús Rodríguez Baño
          • Phone Number: 955 00 80 00

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Recruitment of cases: the cases will be detected by chart review of all patients who underwent a primary arthroplasty and matching the list with microbiological records for SA-PJI infections or discharged records of patients admitted for PJI or any joint procedure.

Recruitment of controls: for each case, the list of patients who underwent a primary arthroplasty in the following week and in the same joint as the case will be reviewed, the first three patients without evidence of PJI during one year will be selected.

Description

Inclusion Criteria:

  • Patients who underwent a primary hip or knee arthroplasty between 2013 and 2016.
  • Diagnosis of SA -PJI in the first 12 months after primary arthroplasty.

Exclusion Criteria:

• Patients with a previous SA infection or prosthesis revision on the index joint (joint which was replaced during arthroplasty).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Cases
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.
Controls
Patient who underwent a primary hip or knee arthroplasty and did not develop any type of PJI during the first year after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of the first SA-PJI after a primary joint arthroplasty
Time Frame: 1 year
1 year
Occurrence of medical events after SA-PJI
Time Frame: 18 months

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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical or microbiological failure after the SA-PJI
Time Frame: 18 months
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

GlaxoSmithKline
UMC Utrecht
Hospital Universitario Virgen Macarena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS-MET-2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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