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

NCT05000723 | Recruiting DMC

• 1 other identifier: S65804
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Prosthesis Infection; Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• Clearance of infection

  Clearance of infection based on DELPHI criteria

  within 5 years

Secondary Outcomes (13)

• Chosen treatment strategy

  within 5 years

• Surgical complications

  within 5 years

• Medical complications

  within 5 years

• Length of hospital stay

  within 5 years

• Discussion of patient in multi-disciplinary meeting

  within 5 years

Study Arms (1)

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

Interventions

Standard of care OTHER

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

PJI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven - Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Georges Vles, Md, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georges Vles, MD, PhD

CONTACT

016340888; georges.vles@uzleuven.be

Stijn Ghijselings, MD

CONTACT

016338872; stijn.ghijselings@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: July 14, 2022
• Primary Completion (Estimated): December 1, 2099
• Study Completion (Estimated): December 1, 2099
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)