NCT06666023 Paper-based Electrochemical Point-of-care Device in Diagnostic of Orthopedic Infections
| NCT ID | NCT06666023 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | PJI |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2024-09-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Periprosthetic Joint infections (PJI) and spondylodiscitis are considered some of the most costly infectious diseases because require at least one surgery, prolonged hospitalisation, rehabilitation care, prolonged antibiotherapy, and extended absence from work in working-age patients. Ortho-PoC will face this issue with a smart and highly innovative diagnostic tool, starting from the point-of-care device for infection diagnosis in the orthopedic field developed and published by the coordinator Fondazione Policlinico Universitario Agostino Gemelli IRCCS and one partner Università degli Studi di Roma Tor Vergata. Ortho-PoC will further go beyond the state of the art by delivering a point-of-care device based on multiparametric analysis, in easily collected synovial fluids or pus. Several samples will be analysed using Ortho-PoC at three different Hospitals (Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Ospedali Riuniti di Foggia, Azienza Ospedaliera Universitaria Policlinico Vanvitelli Napoli) and the data will be treated with artificial intelligence (AI) to deliver an AI-assisted robust, effective, and smart diagnostic device for PJI.
Eligibility 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
Contact & Investigator
Giulio Maccauro
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06666023 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PJI. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06666023 currently recruiting?
Yes, NCT06666023 is actively recruiting participants. Contact the research team at raffaele.vitiello@policlinicogemelli.it for enrollment information.
Where is the NCT06666023 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06666023 clinical trial?
NCT06666023 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Giulio Maccauro at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 400 participants.