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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826108
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
GlaxoSmithKline
Hospital Universitario Virgen Macarena
UMC Utrecht
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:

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.


Condition or disease
Staphylococcus Aureus Prosthetic Joint Infection Arthroplasty Complications

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Occurrence of the first SA-PJI after a primary joint arthroplasty [ Time Frame: 1 year ]
  2. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826108


Contacts
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Contact: Reinaldo Espindola, MD 0034650107427 reinaldoespindola@outlook.com
Contact: Maria Dolores del Toro, MD 0034653937488 mdeltoro@us.es

Locations
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Spain
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Andalucía, Spain, 41009
Contact: Jesús Rodríguez Baño    955 00 80 00      
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
GlaxoSmithKline
Hospital Universitario Virgen Macarena
UMC Utrecht
Publications:

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT03826108    
Other Study ID Numbers: FIS-MET-2019-01
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases