Clinical Trial

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.

Study acronym: PJI MAP/DEF
Active, Not Recruiting
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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.
Trial Details
NCT Number NCT07494630
Lead Sponsor University Hospital, Ghent
Conditions Chronic Periprosthetic Joint Infection, Suspected Periprosthetic Joint Infection, Prosthetic Joint Failure of Unclear Etiology
Enrollment 174 participants
Start Date 2018-09-18
Primary Completion 2024-12-18 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-27