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

Arthroplasty Complications Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03826108
• Other study ID #: FIS-MET-2019-01
• Status: Recruiting
• Start date: April 16, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2019
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Reinaldo Espindola, MD
• Phone: 0034650107427
• Email: reinaldoespindola[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis, Infectious
• Arthroplasty Complications
• Communicable Diseases
• Infection
• Prosthetic Joint Infection
• Staphylococcal Infections
• Staphylococcus Aureus

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Macarena	Sevilla	Andalucía

Sponsors (4)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	GlaxoSmithKline, Hospital Universitario Virgen Macarena, UMC Utrecht

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Del Toro MD, Peñas C, Conde-Albarracín A, Palomino J, Brun F, Sánchez S, Rodríguez-Baño 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. — View 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. — View 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. — View Citation

Lora-Tamayo J, Murillo O, Iribarren JA, Soriano A, Sánchez-Somolinos M, Baraia-Etxaburu JM, Rico A, Palomino J, Rodríguez-Pardo D, Horcajada JP, Benito N, Bahamonde A, Granados A, del Toro MD, Cobo J, Riera M, Ramos A, Jover-Sáenz 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. — View Citation

Senneville E, Joulie D, Legout L, Valette M, Dezèque H, Beltrand E, Roselé B, d'Escrivan T, Loïez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of the first SA-PJI after a primary joint arthroplasty		1 year
Primary	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	Clinical or microbiological failure after the SA-PJI	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