About this trial
Prosthetic Joint Infection (PJI) of a Total Hip Replacement (THR) is a disastrous complication of an otherwise extremely successful surgical procedure. It is associated with a burdensome treatment for the patient, significant challenges for the medical team and high costs for society. As more joint replacements are being performed each year, due to an ageing population and lower thresholds for surgery, the number of PJIs is on the rise. Many of these patients will be referred to University Hospitals Leuven as the physicians have extensive experience with this particular pathology and can offer a multidisciplinary and patient-tailored treatment. Many controversies exist in the field of PJI treatment, both with regard to the surgical aspects as well as the antibiotic treatment. Setting up randomized controlled trials to answer these questions has been proven to be very difficult due to large variations in patients, implants, germs, soft and hard tissues, antibiotic resistance patterns, and so on. Also, surgery for PJIs is usually non-elective / semi-urgent and therefore time to include patients into different trials is limited. Therefore the investigators will prospectively collect data on patients with PJI treated at University Hospitals Leuven, starting 01/01/2022, in order to have knowledge of own results and inform patients about chances of success prior to treatment; perform internal audits and quality checks; answer questions in the field of PJI treatment not suitable for RCTs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
patients diagnosed with PJI of the hip based on EBJIS 2021 criteria
Disqualifiers
Patients unable to provide written informed consent
Patients who prefer treatment outside of University Hospitals Leuven
Patients with infections of the native hip joint
Patients with fracture-related infections (FRI)
Trial population
Every adult patient (\> 18 years), regardless of sex or age, with a PJI of the hip, as based on the EBJIS 2021 criteria, is eligible for inclusion on this study. This would therefore also include women of childbearing age, although this would be extremely rare.
Trial design
Cohort
Prospective
Treatments tested in this trial
Standard of care
Other interventionStandard of care consisting of * clearance of infection * treatment with antibiotics (antisuppressive, DAIR) or surgery (1 stage, 2 stage Girdlestone) * Radiology: X-ray pelvis and hip, X-ray pelvis with kingmark, CT scan pelvis/hip
Treatment groups
Trial outcomes
Primary outcomes
Clearance of infection
Clearance of infection based on DELPHI criteria
Secondary outcomes
Chosen treatment strategy
description of chosen treatments strategy such as suppressive antibiotics, Debridement Antibiotics Implant Retention (DAIR), 1 stage, 2 stage, Girdlestone
Surgical complications
Occurence of sugical complications such as fracture, dislocation, nerve damage, bleeding
Medical complications
Occurence of complications such as delirium, renal failure, deep venous thrombosis, hospital acquired pneumonia
Length of hospital stay
length of hospital stay in days
Sponsors and contacts
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