Exploring Novel Diagnostic Tools for Periprosthetic Joint Infection

NCT ID: NCT05582460

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-07-23

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.

Conditions

Prosthesis-Related Infections; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PJI

Patients diagnosed with a PJI based on the EBJIS criteria ('Infection confirmed')

Reporter Gene Assay

Intervention Type: DIAGNOSTIC_TEST

Transcription factor reporter gene assay using luciferase

Flow Cytometry

Intervention Type: DIAGNOSTIC_TEST

Flow Cytometry Analysis using the Sysmex UF-4000, analyzing for bacteria, mononuclear and polymorphonuclear cells, and red blood cell and white blood cell count.

No PJI

Patients not diagnosed with a PJI based on EBJIS criteria

Reporter Gene Assay

Intervention Type: DIAGNOSTIC_TEST

Transcription factor reporter gene assay using luciferase

Flow Cytometry

Intervention Type: DIAGNOSTIC_TEST

Flow Cytometry Analysis using the Sysmex UF-4000, analyzing for bacteria, mononuclear and polymorphonuclear cells, and red blood cell and white blood cell count.

Interventions

Reporter Gene Assay

Transcription factor reporter gene assay using luciferase

Intervention Type: DIAGNOSTIC_TEST

Flow Cytometry

Flow Cytometry Analysis using the Sysmex UF-4000, analyzing for bacteria, mononuclear and polymorphonuclear cells, and red blood cell and white blood cell count.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

2022-2054

Identifier Type: -

Identifier Source: org_study_id