Evaluating diagnostic markers for joint infections in hip and knee surgeries
Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Fluid Markers for the Diagnosis of Periprosthetic Hip and Knee Joint Infections
This study is testing if certain blood and joint fluid markers can help doctors quickly and accurately diagnose joint infections in patients having hip or knee revision surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT04858217 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the diagnostic accuracy and cost-effectiveness of serum and synovial markers in identifying periprosthetic joint infections (PJI) in patients undergoing revision surgery for hip or knee replacements. By analyzing the combination of these biomarkers, the research seeks to improve the speed and accuracy of PJI diagnosis, which is crucial for determining the appropriate surgical strategy. The study will involve patients hospitalized for revision surgery, utilizing existing clinical data and laboratory examinations to evaluate the effectiveness of these markers.
Who should consider this trial
Good fit: Ideal candidates for this study are patients requiring hip or knee replacement surgery due to late joint prosthesis infection or non-infectious causes, with a history of at least 90 days since their initial surgery.
Not a fit: Patients with early joint prosthesis infections or those with infections in joints other than the hip or knee may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses of joint infections, improving treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using biomarkers for diagnosing infections, but this specific combination of serum and synovial markers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Gianluca Giavaresi, MD — Istituto Ortopedico Rizzoli
- Study coordinator: Gianluca Giavaresi, MD
- Email: gianluca.giavaresi@ior.it
- Phone: +39 3774548728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.