Clinical trial NCT03826108: ARTHR-IS (Arthroplasties' Infections Due to Staphylococcus Aureus)
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Staphylococcus Aureus
Prosthetic Joint Infection
Arthroplasty Complications
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Hospital Universitario Virgen Macarena
name: UMC Utrecht
First posted: 2019-02-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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).

Primary outcomes:
measure: Occurrence of the first SA-PJI after a primary joint arthroplasty
timeFrame: 1 year
measure: Occurrence of medical events after SA-PJI
timeFrame: 18 months
Secondary outcomes:
measure: Clinical or microbiological failure after the SA-PJI
timeFrame: 18 months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucía
Study officials:
References:
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: 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: 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: 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: 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: Espindola R, Vella V, Benito N, Mur I, Tedeschi S, Zamparini E, Hendriks JGE, Sorli L, Murillo O, Soldevila L, Scarborough M, Scarborough C, Kluytmans J, Ferrari MC, Pletz MW, Mcnamara I, Escudero-Sanchez R, Arvieux C, Batailler C, Dauchy FA, Liu WY, Lora-Tamayo J, Praena J, Ustianowski A, Cinconze E, Pellegrini M, Bagnoli F, Rodriguez-Bano J, Del Toro MD; ARTHR-IS Group. Rates and Predictors of Treatment Failure in Staphylococcus aureus Prosthetic Joint Infections According to Different Management Strategies: A Multinational Cohort Study-The ARTHR-IS Study Group. Infect Dis Ther. 2022 Dec;11(6):2177-2203. doi: 10.1007/s40121-022-00701-0. Epub 2022 Oct 15.