Paper-based Electrochemical Point-of-care Device in Diagnostic of Orthopedic Infections (Ortho-PoC)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

PJI

Spondylodiscitis

Treatments

Device: Device

Study type

Observational

Funder types

Other

Identifiers

NCT06666023

PNRR-POC-2023-12378291

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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