Trials / Unknown
UnknownNCT03826108
ARTHR-IS (Arthroplasties' Infections Due to Staphylococcus Aureus)
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2019-04-16
- Primary completion
- 2020-05-01
- Completion
- 2020-12-31
- First posted
- 2019-02-01
- Last updated
- 2019-08-09
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03826108. Inclusion in this directory is not an endorsement.