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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard of care

    Other intervention

    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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: PJI patients1 intervention

Trial outcomes

Primary outcomes

1

Clearance of infection

Clearance of infection based on DELPHI criteria

Time frame
within 5 years

Secondary outcomes

1

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
2

Surgical complications

Occurence of sugical complications such as fracture, dislocation, nerve damage, bleeding

Time frame
within 5 years
3

Medical complications

Occurence of complications such as delirium, renal failure, deep venous thrombosis, hospital acquired pneumonia

Time frame
within 5 years
4

Length of hospital stay

length of hospital stay in days

Time frame
within 5 years

Other outcomes

Sponsors and contacts

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