An observational study in Prosthetic Joint Infection and Hip Prosthesis Infection, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
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.
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.
Nevertheless, prospectively collecting data on patients with PJI who are not involved in RCTs can already be helpful. It would allow the investigators to provide the patients with percentages of success of certain interventions based on historical results. At the moment the investigators have to rely on results reported by other groups, who might use different techniques or a facing a different germ spectrum.
Furthermore, prospectively collecting data on this cohort of patients, would make it possible for the investigators to do internal audits for quality control. Being able to perform simple checks, for example is every patient discussed in the multi-disciplinary team meeting, or is the hospital switching to targeted antibiotics soon enough, would already add to the quality of the service and could lead to adjustments in the protocols.
Also, certain scientific questions, which do not lend themselves to RCTs, such as the rate of success of treatment of PJI caused by rare germs (e.g. fungi) or in a specific population (e.g. octogenarians, transplant patients), could be answered by maintaining a prospective database
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients (older than 18 years) with PJI of a total hip replacement treated at University Hospitals Leuven. Diagnosis of PJI of the hip is made based on the EBJIS 2021 criteria. Patients will receive standard of care.
Other: Standard of care
Standard 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
Clearance of infection
Clearance of infection based on DELPHI criteria
Time frame: within 5 years
Chosen treatment strategy
description of chosen treatments strategy such as suppressive antibiotics, Debridement Antibiotics Implant Retention (DAIR), 1 stage, 2 stage, Girdlestone
Time frame: within 5 years
Surgical complications
Occurence of sugical complications such as fracture, dislocation, nerve damage, bleeding
Time frame: within 5 years
Medical complications
Occurence of complications such as delirium, renal failure, deep venous thrombosis, hospital acquired pneumonia
Time frame: within 5 years
Length of hospital stay
length of hospital stay in days
Time frame: within 5 years
Discussion of patient in multi-disciplinary meeting
Whether or not patient is discussed in multi-disciplinary meeting
Time frame: within 5 years
Readmissions within 30 days
Occurence of readmissions within 30 days
Time frame: within 30 days
Mortality
Mortality of patients
Time frame: within 5 years
EuroQol 5D -3L
Patients Reported Outcome Measures
Time frame: within 5 years
General treatment discussion
Appropriate work-up performed? Unnecessary aspirations? Unnecessary nuclear imaging?
Time frame: within 5 years
Hip disability and Osteoarthritis Outcome Score
Patients Reported Outcome Measures
Time frame: within 5 years
Western Ontario and McMaster Universities Osteoarthritis Index
Patients Reported Outcome Measures
Time frame: within 5 years
Readmissions within 90 days
Occurence of readmissions within 90 days
Time frame: within 90 days
Changes in treatment
Whether or not there are changes in treatment consequent to multi-disciplinary meeting
Time frame: within 5 years
Plan to share: No
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Universitaire Ziekenhuizen KU Leuven