A new device for diagnosing orthopedic infections
The Diagnostic Pillar for Diagnosis of Infections in the Orthopedic Field: Smart and Sustainable Paper-based Electrochemical Point-of-care Device Assisted by Artificial Intelligence
This study is testing a new easy-to-use device that helps doctors quickly diagnose joint infections in patients using simple samples like fluid or pus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06666023 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates a novel paper-based electrochemical point-of-care device designed to diagnose periprosthetic joint infections (PJI) and spondylodiscitis. The device analyzes easily collected samples such as synovial fluids or pus to provide rapid diagnostic results. Conducted at three hospitals, the study aims to improve the management of infections that often require extensive medical intervention. The approach leverages multiparametric analysis to enhance diagnostic accuracy in orthopedic settings.
Who should consider this trial
Good fit: Ideal candidates include patients who have received a joint implant or spine surgery and exhibit clear signs of infection.
Not a fit: Patients who are pregnant, currently undergoing antibiotic therapy, or have cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce the time and costs associated with diagnosing orthopedic infections, leading to better patient outcomes.
How similar studies have performed: While similar diagnostic approaches have been explored, this specific device represents a novel application in the orthopedic field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients that received a joint implant or spine surgery, clear signs of infection (according to international guidelines) * patients off antibiotic therapy at least for two weeks * Sample biopsy of minimum 1 ml. Exclusion Criteria: * pregnant women, * patient affected by cancer * patient under antibiotic therapy
Where this trial is running
Rome, Lazio
- Fondazione Policlinico Gemelli IRCCS — Rome, Lazio, Italy (Recruiting)
Study contacts
- Principal investigator: Giulio Maccauro — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Raffaele Vitiello, MD PhD
- Email: raffaele.vitiello@policlinicogemelli.it
- Phone: +39 - 0630151
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.