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.
Active, not recruitingNot applicableNCT07494630
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- The Unhappy Patient With a Painful Joint Endoprosthesis: Mapping a Periprosthetic Joint Infection and Analysis of Themicrobiome/Biofilm
- 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
- Sponsor
- University Hospital, Ghent
- Start date
- 2018-09-18
- Primary completion
- 2024-12-18
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Belgium
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adult patients * Presence of a joint prosthesis. * Clinical suspicion of chronic periprosthetic joint infection. * Scheduled for diagnostic arthroscopy and/or open surgical evaluation as part of standard care. * Written informed consent provided. Exclusion Criteria: * Acute postoperative infections. * Inability or refusal to provide informed consent. * Insufficient clinical data or samples for diagnostic evaluation.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07494630