Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Markers

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Apr 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how well certain blood and joint fluid markers can help diagnose infections that occur around joint replacements, known as periprosthetic joint infections (PJI). These infections can happen after surgeries like hip or knee replacements and can lead to the need for additional surgeries if not diagnosed accurately. The researchers want to find out if using a combination of these markers can improve the speed and accuracy of diagnosing these infections, which would help doctors choose the best treatment options for their patients.

To be eligible for this trial, participants need to be adults aged 65 to 74 who are scheduled for hip or knee replacement surgery due to either an infection that has been present for at least 90 days or non-infectious issues like wear and instability. Participants should have prior medical tests and scans available for review. Those with recent infections (less than 90 days), infections in other joints, severe cognitive or psychiatric conditions, or who are pregnant cannot join the study. If you participate, you can expect to have your blood and joint fluid tested to see how well these markers work in diagnosing infections, which could ultimately help improve treatment for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients requiring hip or knee replacement surgery: i) for 'late' joint prosthesis infection, present for at least 90 days from the date of the arthroplasty (first surgical phase); II) for non-infectious causes (mobilization, wear, instability, misalignment, adverse reactions to local tissues or other aseptic causes), also present for at least 90 days, and which have not had other re-operations on the same joint, and which will be a one-step review;
• • Previous clinical data and laboratory and radiological examinations available.
• Exclusion Criteria:
• • Patients affected by 'early' joint prosthesis infection, with clinical symptom latency of less than 90 days (in this specific subset of patients there is in fact still considerable heterogeneity and little consensus about the diagnostic levels of white blood cell count and percentage of neutrophils).
• • Patients suffering from joint prosthesis infection involving joints other than the hip or knee.
• • Severe cognitive impairment or psychiatric disorders;
• • Pregnant women.