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

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.

Study Overview

• Status: Recruiting
• Conditions: Prosthetic Joint Infection; Hip Prosthesis Infection
• Intervention / Treatment: Other: Standard of care

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

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Georges Vles, MD, PhD; Phone Number: 016340888; Email: georges.vles@uzleuven.be
• Study Contact Backup: Name: Stijn Ghijselings, MD; Phone Number: 016338872; Email: stijn.ghijselings@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Leuven - Gasthuisberg
    • Contact: Georges Vles, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PJI patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance of infection	Clearance of infection based on DELPHI criteria	within 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chosen treatment strategy	description of chosen treatments strategy such as suppressive antibiotics, Debridement Antibiotics Implant Retention (DAIR), 1 stage, 2 stage, Girdlestone	within 5 years
Surgical complications	Occurence of sugical complications such as fracture, dislocation, nerve damage, bleeding	within 5 years
Medical complications	Occurence of complications such as delirium, renal failure, deep venous thrombosis, hospital acquired pneumonia	within 5 years
Length of hospital stay	length of hospital stay in days	within 5 years
Discussion of patient in multi-disciplinary meeting	Whether or not patient is discussed in multi-disciplinary meeting	within 5 years
Readmissions within 30 days	Occurence of readmissions within 30 days	within 30 days
Mortality	Mortality of patients	within 5 years
EuroQol 5D -3L	Patients Reported Outcome Measures	within 5 years
General treatment discussion	Appropriate work-up performed? Unnecessary aspirations? Unnecessary nuclear imaging?	within 5 years
Hip disability and Osteoarthritis Outcome Score	Patients Reported Outcome Measures	within 5 years
Western Ontario and McMaster Universities Osteoarthritis Index	Patients Reported Outcome Measures	within 5 years
Readmissions within 90 days	Occurence of readmissions within 90 days	within 90 days
Changes in treatment	Whether or not there are changes in treatment consequent to multi-disciplinary meeting	within 5 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Georges Vles, Md, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Estimated): December 1, 2099
• Study Completion (Estimated): December 1, 2099

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Disease Attributes; Arthritis; Joint Diseases; Infections; Communicable Diseases; Arthritis, Infectious; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: S65804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No