PROFITH: Long Term Follow-up of Patients With Prosthetic Joint Infection of the Hip Treated at University Hospitals Leuven
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Clearance of infection [within 5 years]
Clearance of infection based on DELPHI criteria
Secondary Outcome Measures
- Chosen treatment strategy [within 5 years]
description of chosen treatments strategy such as suppressive antibiotics, Debridement Antibiotics Implant Retention (DAIR), 1 stage, 2 stage, Girdlestone
- Surgical complications [within 5 years]
Occurence of sugical complications such as fracture, dislocation, nerve damage, bleeding
- Medical complications [within 5 years]
Occurence of complications such as delirium, renal failure, deep venous thrombosis, hospital acquired pneumonia
- Length of hospital stay [within 5 years]
length of hospital stay in days
- Discussion of patient in multi-disciplinary meeting [within 5 years]
Whether or not patient is discussed in multi-disciplinary meeting
- Readmissions within 30 days [within 30 days]
Occurence of readmissions within 30 days
- Mortality [within 5 years]
Mortality of patients
- EuroQol 5D -3L [within 5 years]
Patients Reported Outcome Measures
- General treatment discussion [within 5 years]
Appropriate work-up performed? Unnecessary aspirations? Unnecessary nuclear imaging?
- Hip disability and Osteoarthritis Outcome Score [within 5 years]
Patients Reported Outcome Measures
- Western Ontario and McMaster Universities Osteoarthritis Index [within 5 years]
Patients Reported Outcome Measures
- Readmissions within 90 days [within 90 days]
Occurence of readmissions within 90 days
- Changes in treatment [within 5 years]
Whether or not there are changes in treatment consequent to multi-disciplinary meeting
Eligibility Criteria
Criteria
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
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Patients who prefer treatment outside of University Hospitals Leuven
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals Leuven - Gasthuisberg | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
Investigators
- Principal Investigator: Georges Vles, Md, PhD, Universitaire Ziekenhuizen Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S65804