Actively Recruiting
Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Markers
Led by Istituto Ortopedico Rizzoli · Updated on 2025-09-22
270
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
I
Istituto Ortopedico Rizzoli
Lead Sponsor
I
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsor
AI-Summary
What this Trial Is About
Total joint replacement (TJR) is an increasing effective procedure in orthopedics. However, TJR failure due to aseptic or septic loosening remains an important problem, often due to predisposing factors of the patient, which determine the need to perform a revision surgery. In light of the recent conclusions emerged on the still open problems concerning the diagnostic accuracy of serum and synovial fluid markers in the diagnosis of peri-prosthetic joint infection (PJI), the project aims at evaluating the diagnostic accuracy and cost-effectiveness of the combination of serum and/or synovial markers in the diagnosis of PJI. Through a diagnostic clinical study on patients hospitalized for revision surgery the project would provide evidences on the potentiality of the combination of some markers in accelerating the PJI diagnosis for the best selection of surgical strategy, choosing the suitable cutoff thresholds to mitigate the effect of some factors on markers' discriminatory capability.
CONDITIONS
Official Title
Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Markers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients requiring hip or knee replacement surgery for late joint prosthesis infection present for at least 90 days
- Patients requiring hip or knee replacement surgery for non-infectious causes present for at least 90 days
- No prior re-operations on the same joint
- Availability of previous clinical, laboratory, and radiological data
You will not qualify if you...
- Patients with early joint prosthesis infection with symptoms less than 90 days
- Patients with joint prosthesis infection in joints other than hip or knee
- Severe cognitive impairment or psychiatric disorders
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40134
Actively Recruiting
Research Team
G
Gianluca Giavaresi, MD
CONTACT
M
Milena Fini, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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