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 | Active Not Recruiting DMC

• 2 other identifiers: BC-08886FWOOPR2023006203
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Periprosthetic joint infection; Chronic PJI; Diagnostic accuracy; Synovial fluid analysis; Next-generation sequencing (NGS); Nuclear imaging; Arthroscopy; Microbiological cultures; Histopathology; Unified PJI definition

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Diagnostic accuracy (sensitivity, specificity) of individual and combined diagnostic modalities for chronic PJI, using a comprehensive multidisciplinary reference standard.

  From the start of standard of care treatment during phase 1, 2, or 3 until 1 year after collection date.

Secondary Outcomes (1)

• Refining the diagnosis or treatment of the donor based on new diagnostic data

  From the start of standard of care treatment during phase 1, 2, or 3 until 1 year after collection date.

Study Arms (1)

Single arm study with observational and diagnostic puproses

OTHER

Participants receive diagnostic investigations that are clinically indicated as part of routine care for suspected chronic periprosthetic joint infection. No additional diagnostic or therapeutic procedures are mandated by the study protocol.

Diagnostic Test: Comprehensive Diagnostic Work-up for Suspected Chronic Periprosthetic Joint Infection

Interventions

Comprehensive Diagnostic Work-up for Suspected Chronic Periprosthetic Joint Infection DIAGNOSTIC_TEST

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.

Single arm study with observational and diagnostic puproses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Acute postoperative infections.
• Inability or refusal to provide informed consent.
• Insufficient clinical data or samples for diagnostic evaluation.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent (UZ Gent), Belgium

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: March 27, 2026
• Study Start: September 18, 2018
• Primary Completion: December 18, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)