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

NCT ID: NCT03826108

Last Updated: 2019-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-16

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Staphylococcus Aureus Prosthetic Joint Infection Arthroplasty Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Hospital Universitario Virgen Macarena

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role collaborator

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Virgen Macarena

Seville, Andalusia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Reinaldo Espindola, MD

Role: CONTACT

0034650107427

Maria Dolores del Toro, MD

Role: CONTACT

0034653937488

Facility Contacts

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Jesús Rodríguez Baño

Role: primary

955 00 80 00

References

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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.

Reference Type BACKGROUND
PMID: 17403800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26948176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29715553 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22942204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21810745 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36242742 (View on PubMed)

Other Identifiers

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FIS-MET-2019-01

Identifier Type: -

Identifier Source: org_study_id

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