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Long Term Follow-up of Patients With Prosthetic Joint Infection of the Hip Treated at University Hospitals Leuven

Long Term Follow-up of Patients With Prosthetic Joint Infection of the Hip Treated at University Hospitals Leuven

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05000723
Acronym
PROFITH
Enrollment
50
Registered
2021-08-11
Start date
2022-07-14
Completion date
2099-12-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Prosthesis Infection, Prosthetic Joint Infection

Brief summary

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.

Detailed description

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

Interventions

OTHERStandard 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

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older * patients diagnosed with PJI of the hip based on EBJIS 2021 criteria

Exclusion criteria

* 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) * Patients with uncertain diagnosis of PJI according to the 2021 EBJIS criteria * Patient younger than 18 years

Design outcomes

Primary

MeasureTime frameDescription
Clearance of infectionwithin 5 yearsClearance of infection based on DELPHI criteria

Secondary

MeasureTime frameDescription
Chosen treatment strategywithin 5 yearsdescription of chosen treatments strategy such as suppressive antibiotics, Debridement Antibiotics Implant Retention (DAIR), 1 stage, 2 stage, Girdlestone
Surgical complicationswithin 5 yearsOccurence of sugical complications such as fracture, dislocation, nerve damage, bleeding
Medical complicationswithin 5 yearsOccurence of complications such as delirium, renal failure, deep venous thrombosis, hospital acquired pneumonia
Length of hospital staywithin 5 yearslength of hospital stay in days
Discussion of patient in multi-disciplinary meetingwithin 5 yearsWhether or not patient is discussed in multi-disciplinary meeting
Readmissions within 30 dayswithin 30 daysOccurence of readmissions within 30 days
Mortalitywithin 5 yearsMortality of patients
EuroQol 5D -3Lwithin 5 yearsPatients Reported Outcome Measures
General treatment discussionwithin 5 yearsAppropriate work-up performed? Unnecessary aspirations? Unnecessary nuclear imaging?
Hip disability and Osteoarthritis Outcome Scorewithin 5 yearsPatients Reported Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Indexwithin 5 yearsPatients Reported Outcome Measures
Readmissions within 90 dayswithin 90 daysOccurence of readmissions within 90 days
Changes in treatmentwithin 5 yearsWhether or not there are changes in treatment consequent to multi-disciplinary meeting

Countries

Belgium

Contacts

CONTACTGeorges Vles, MD, PhD
georges.vles@uzleuven.be016340888
CONTACTStijn Ghijselings, MD
stijn.ghijselings@uzleuven.be016338872
PRINCIPAL_INVESTIGATORGeorges Vles, Md, PhD

Universitaire Ziekenhuizen KU Leuven

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026