Paper-based Electrochemical Point-of-care Device in Diagnostic of Orthopedic Infections

Recruiting now

Conditions studied: PJI, Spondylodiscitis

In brief

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.

Key facts

Study ID

NCT06666023

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

400

Starts

2024-09-01

Expected to finish

2026-09-01

Last updated by the study team

2024-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• pregnant women,
• patient affected by cancer
• patient under antibiotic therapy

Where it is running

• Fondazione Policlinico Gemelli IRCCS — Rome, Lazio, Italy (enrolling)

Full record on ClinicalTrials.gov

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