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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.
Sponsor: University Hospital, Ghent
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.
Official title: The Unhappy Patient With a Painful Joint Endoprosthesis: Mapping a Periprosthetic Joint Infection and Analysis of Themicrobiome/Biofilm
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2018-09-18
Completion Date
2027-12-31
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
University Hospital Ghent (UZ Gent), Belgium
Ghent, Oost-Vlaanderen, Belgium