Clinical trial NCT05582460: Exploring Novel Diagnostic Tools for Periprosthetic Joint Infection
Official title: Exploring the Value of the Reporter Gene Assay and Flow Cytometry of Synovial Fluid in Total Hip and Knee Arthroplasty as a Diagnostic Tool for Periprosthetic Joint Infection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prosthesis-Related Infections
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visiting the outpatient clinic of the participating hospitals and planned for elective revision surgery of their THA or TKA.

Brief summary: Joint replacement is a valuable surgical intervention that improves quality of life, provides pain relief, and restores function of patients. However, some patients need revision surgery due to failure of the implant, with periprosthetic joint infection (PJI) remaining a rare but serious complication following total hip (THA) and knee (TKA) arthroplasty. Diagnosing PJI is a major challenge as no diagnostic test with absolute accuracy exists. The diagnosis is based on a combination of clinical findings, laboratory results from peripheral blood and synovial fluid, microbiological culture, histological evaluation of periprosthetic tissue, and intraoperative findings. However, the preoperative diagnosis can be inconclusive and operative criteria are required for the definitive diagnosis. Therefore, novel diagnosing tools for identification of PJI are necessary.

A recent study using a gene reporter assay, identified biomarkers in synovial fluid that define joint states in patients with osteoarthritis.However, no previous studies have investigated cellular signaling in synovial fluid of patients with PJI. With this study we want to explore the potential of a reporter gene assay of synovial fluid in patients with PJI and without PJI of their TKA and THA.

Also, flow cytometry analysis of biological fluids has recently received increased attention as a potentially valuable method in diagnosing infections. For example, the method is already used to analyze urine samples for urinary tract infections. Recently, researchers have now also used this method to screen for the presence of bacteria. The most important limitation of flow cytometry analysis of synovial fluids for bacteria to date is that it is unclear as to which bacteria count value - the cutoff value - represent patients with PJI and which represent patients without PJI. With this study we want to explore the potential of flow cytometry analysis of synovial fluid in categorizing patients with PJI and without PJI.

Our primary objective is to explore the value of synovial fluid analysis using a reporter gene assay and flow cytometry in the detection of a periprosthetic joint infection.


Eligibility criteria: Inclusion Criteria:

* All patients planned for elective THA or TKA revision surgery with revision of one or more fixed components will be eligible to participate in this study.

Exclusion Criteria:

* are planned for a revision of single mobile parts only;
* have received intravenous and/or oral antibiotics within 2 weeks before the diagnostic workup and/or surgery;
* are unable to provide their consent for use of their human tissues for medical research.

Primary outcomes:
measure: Fold change of luciferase assay
timeFrame: Within 30 days of surgery
measure: Diagnostic performance of flow cytometric analysis
timeFrame: Within 4 hours of surgery
Secondary outcomes:
measure: Sensitivity of the flow cytometric analysis
timeFrame: Within 4 hours of surgery
measure: Specificity of the flow cytometric analysis
timeFrame: Within 4 hours of surgery
measure: Positive predictive value of the flow cytometric analysis
timeFrame: Within 4 hours of surgery
measure: Negative predictive value of the flow cytometric analysis
timeFrame: Within 4 hours of surgery
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
References: