University Hospitals Leuven - Gasthuisberg
Leuven, 3000, Belgium
Location status: Recruiting
Location contact
Georges Vles, MD, PhD
CONTACT
NCT Number: NCT05000723
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Leuven, 3000, Belgium
Location status: Recruiting
Georges Vles, MD, PhD
CONTACT
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard of care consisting of
Time frame: within 5 years
Clearance of infection based on DELPHI criteria
Time frame: within 5 years
description of chosen treatments strategy such as suppressive antibiotics, Debridement Antibiotics Implant Retention (DAIR), 1 stage, 2 stage, Girdlestone
Time frame: within 5 years
Occurence of sugical complications such as fracture, dislocation, nerve damage, bleeding
Time frame: within 5 years
Occurence of complications such as delirium, renal failure, deep venous thrombosis, hospital acquired pneumonia
Time frame: within 5 years
length of hospital stay in days
Time frame: within 5 years
Whether or not patient is discussed in multi-disciplinary meeting
Time frame: within 30 days
Occurence of readmissions within 30 days
Time frame: within 5 years
Mortality of patients
Time frame: within 5 years
Patients Reported Outcome Measures
Time frame: within 5 years
Appropriate work-up performed? Unnecessary aspirations? Unnecessary nuclear imaging?
Time frame: within 5 years
Patients Reported Outcome Measures
Time frame: within 5 years
Patients Reported Outcome Measures
Time frame: within 90 days
Occurence of readmissions within 90 days
Time frame: within 5 years
Whether or not there are changes in treatment consequent to multi-disciplinary meeting
Contact information is provided by the study sponsor or research team.
Georges Vles, MD, PhD
CONTACT
Stijn Ghijselings, MD
CONTACT
Universitaire Ziekenhuizen KU Leuven
Other
Acronym: PROFITH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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