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NCT Number: NCT05000723

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven - Gasthuisberg

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Georges Vles, MD, PhD

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Clearance of infection

    Time frame: within 5 years

    Clearance of infection based on DELPHI criteria

Secondary outcomes

  1. Chosen treatment strategy

    Time frame: within 5 years

    description of chosen treatments strategy such as suppressive antibiotics, Debridement Antibiotics Implant Retention (DAIR), 1 stage, 2 stage, Girdlestone

  2. Surgical complications

    Time frame: within 5 years

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

  3. Medical complications

    Time frame: within 5 years

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

  4. Length of hospital stay

    Time frame: within 5 years

    length of hospital stay in days

  5. Discussion of patient in multi-disciplinary meeting

    Time frame: within 5 years

    Whether or not patient is discussed in multi-disciplinary meeting

  6. Readmissions within 30 days

    Time frame: within 30 days

    Occurence of readmissions within 30 days

  7. Mortality

    Time frame: within 5 years

    Mortality of patients

  8. EuroQol 5D -3L

    Time frame: within 5 years

    Patients Reported Outcome Measures

  9. General treatment discussion

    Time frame: within 5 years

    Appropriate work-up performed? Unnecessary aspirations? Unnecessary nuclear imaging?

  10. Hip disability and Osteoarthritis Outcome Score

    Time frame: within 5 years

    Patients Reported Outcome Measures

  11. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: within 5 years

    Patients Reported Outcome Measures

  12. Readmissions within 90 days

    Time frame: within 90 days

    Occurence of readmissions within 90 days

  13. Changes in treatment

    Time frame: within 5 years

    Whether or not there are changes in treatment consequent to multi-disciplinary meeting

Study contacts

Contact information is provided by the study sponsor or research team.

Georges Vles, MD, PhD

CONTACT

[email protected]

016340888

Stijn Ghijselings, MD

CONTACT

[email protected]

016338872

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: PROFITH

Important dates

Study start
2022
Primary completion
2099
Study completion
2099
First posted
Aug 11, 2021
Registry last updated
Mar 16, 2026

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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