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Joint Endoprostheses Can Succesfully Treat Disabling Osteoarthritis. However, Infection is an Important Cause of Failure. Adequate Diagnostics Remains Challenging. Combining Advanced Imaging With Next-generation Sequencing of Samples Obtained Endoscopically Should Aid in Mapping and Characterizing.

NCT07494630 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-03-27

No results posted yet for this study

Summary

This prospective observational diagnostic study aims to improve the accuracy and timeliness of diagnosing chronic periprosthetic joint infection (PJI). By systematically integrating clinical history, serological markers, synovial fluid analysis, microbiological cultures, next-generation sequencing (NGS), histopathology, minimally invasive arthroscopic sampling, open surgical sampling, sonication, and nuclear imaging, the study evaluates which diagnostic factors and combinations thereof most reliably identify the presence, extent, location, and causative microorganism(s) of PJI. The ultimate objective is to provide evidence-based recommendations to refine and optimize the current unified PJI diagnostic definition.

Conditions

  • Chronic Periprosthetic Joint Infection
  • Suspected Periprosthetic Joint Infection
  • Prosthetic Joint Failure of Unclear Etiology

Interventions

DIAGNOSTIC_TEST

Comprehensive Diagnostic Work-up for Suspected Chronic Periprosthetic Joint Infection

Participants undergo a comprehensive, multimodal diagnostic work-up for suspected chronic periprosthetic joint infection as part of standard clinical care. This diagnostic assessment may include clinical history evaluation, serological testing, synovial fluid analysis, microbiological cultures, next-generation sequencing (NGS), histopathological examination, nuclear imaging, minimally invasive arthroscopic sampling, open surgical sampling, and sonication of explanted components where applicable. No experimental treatment is administered. All diagnostic procedures are performed according to routine clinical practice. The study evaluates the diagnostic performance, concordance, and added value of individual and combined diagnostic modalities for the detection, characterization, and localization of periprosthetic joint infection.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2024-12-18
Completion
2027-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07494630 on ClinicalTrials.gov