Paper-based Electrochemical Point-of-care Device in Diagnostic of Orthopedic Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device.
- Who it may be relevant to
- Registry conditions: PJI, Spondylodiscitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device Device
Use of the device in groups to test its ability to diagnose infections.
Primary outcome measures
- Sensitivity and Specificity [Time frame: at enrollement]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Gemelli IRCCS — Rome
Identifiers
NCT: NCT06666023 · PNRR-POC-2023-12378291