Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Se
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
| Condition(s) | Prosthetic Joint Infection |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 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 marke |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Istituto Ortopedico Rizzoli |
| Locations | Bologna, Italy |
| Start date | 2022-02-01 |
| NCT ID | NCT04858217 |
| Official listing | https://clinicaltrials.gov/study/NCT04858217 |