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

Prosthetic Joint Infection Clinical Trial

— PROFITH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000723
• Other study ID #: S65804
• Status: Recruiting
• Start date: July 14, 2022
• Est. completion date: December 2099

Study information

• Verified date: October 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Georges Vles, MD, PhD
• Phone: 016340888
• Email: georges.vles[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2099
• Est. primary completion date: December 2099
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Hip Prosthesis Infection
• Infections
• Prosthetic Joint Infection

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven - Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance of infection	Clearance of infection based on DELPHI criteria	within 5 years
Secondary	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
Secondary	Surgical complications	Occurence of sugical complications such as fracture, dislocation, nerve damage, bleeding	within 5 years
Secondary	Medical complications	Occurence of complications such as delirium, renal failure, deep venous thrombosis, hospital acquired pneumonia	within 5 years
Secondary	Length of hospital stay	length of hospital stay in days	within 5 years
Secondary	Discussion of patient in multi-disciplinary meeting	Whether or not patient is discussed in multi-disciplinary meeting	within 5 years
Secondary	Readmissions within 30 days	Occurence of readmissions within 30 days	within 30 days
Secondary	Mortality	Mortality of patients	within 5 years
Secondary	EuroQol 5D -3L	Patients Reported Outcome Measures	within 5 years
Secondary	General treatment discussion	Appropriate work-up performed? Unnecessary aspirations? Unnecessary nuclear imaging?	within 5 years
Secondary	Hip disability and Osteoarthritis Outcome Score	Patients Reported Outcome Measures	within 5 years
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index	Patients Reported Outcome Measures	within 5 years
Secondary	Readmissions within 90 days	Occurence of readmissions within 90 days	within 90 days
Secondary	Changes in treatment	Whether or not there are changes in treatment consequent to multi-disciplinary meeting	within 5 years