International consensus on periprosthetic joint infection: description of the consensus process.
William Cats-Baril, Thorsten Gehrke, Katherine Huff...
https://pubmed.ncbi.nlm.nih.gov/24155178/Actively Recruiting
Led by Istituto Ortopedico Rizzoli · Updated on 2025-09-22
270
Participants Needed
1
Research Sites
41 weeks
Total Duration
Researchers are investigating diagnostic methods for periprosthetic joint infection PJI, a serious complication following total joint replacement TJR surgeries, especially in hip and knee joints. The study aims to evaluate the accuracy and cost-effectiveness of combining different serum and synovial fluid markers to improve the diagnosis of PJI, helping to guide the choice of surgical and antimicrobial treatments. This observational study focuses on patients hospitalized for revision surgery due to suspected PJI or other causes around the replaced joint. The study involves analyzing various blood and synovial fluid markers such as white blood cell count, C-reactive protein, alpha-defensin, and others, measured within a week or two months depending on the marker. It compares combinations of these markers to identify those with the highest diagnostic accuracy and cost-effectiveness, based on established criteria by the Musculoskeletal Infection Society. This includes both preoperative and intraoperative assessments, aiming to accelerate diagnosis and optimize surgical strategies. Participants will undergo evaluations including blood tests, synovial fluid analysis, clinical and radiological examinations, and laboratory assessments of microbial resistance and biofilm formation. The primary outcomes are multiple inflammatory and infection markers measured within seven days or two months. The study monitors diagnostic effectiveness and microbial characteristics to improve PJI management. Participants are involved during their hospitalization for revision surgery, with no additional treatment interventions outside standard care. The study is expected to continue until March 2026.
CONDITIONS
Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Markers
G
Gianluca Giavaresi, MD
M
Milena Fini, MD
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Istituto Ortopedico Rizzoli
Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 months
Participants undergo serum and synovial fluid tests to evaluate markers for diagnosing periprosthetic joint infections.
1 to 2 visits depending on tests performed
Duration - Up to 2 months
Participants are observed for outcomes related to infection diagnosis and antimicrobial resistance after diagnostic evaluation.
Follow-up assessments may occur depending on initial findings
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsor