NCT03826108

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

January 30, 2019

Last Update Submit

August 7, 2019

Conditions

Staphylococcus AureusProsthetic Joint InfectionArthroplasty Complications

Outcome Measures

Primary Outcomes (2)

  • Occurrence of the first SA-PJI after a primary joint arthroplasty

    1 year

  • Occurrence of medical events after SA-PJI

    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 Outcomes (1)

  • Clinical or microbiological failure after the SA-PJI

    18 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, Andalusia, 41009, Spain

RECRUITING

Related Publications (6)

  • 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: 17403800BACKGROUND

  • 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: 26948176BACKGROUND

  • 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: 29715553BACKGROUND

  • 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: 22942204BACKGROUND

  • 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: 21810745BACKGROUND

  • 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.

    PMID: 36242742DERIVED

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Reinaldo Espindola, MD

CONTACT

0034650107427reinaldoespindola@outlook.com

Maria Dolores del Toro, MD

CONTACT

0034653937488mdeltoro@us.es

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

April 16, 2019

Primary Completion

May 1, 2020

Study Completion

December 31, 2020

Last Updated

August 9, 2019

Record last verified: 2019-01

Locations

ES(1)