Status:
RECRUITING
Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Markers
Lead Sponsor:
Istituto Ortopedico Rizzoli
Collaborating Sponsors:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Prosthetic Joint Infection
Eligibility:
All Genders
18+ years
Brief Summary
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 facto...
Detailed Description
Total joint arthroplasties (TJA) are constantly increasing in older and multi-morbid patients; knee and hip joints are the most frequently treated due to high incidence of osteoarthritis in these join...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04858217
Start Date
February 1 2022
End Date
March 31 2026
Last Update
September 22 2025
Active Locations (1)
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1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40134