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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06666023

Acronym

Ortho-PoC

Enrollment

400

Registered

2024-10-30

Start date

2024-09-01

Completion date

2026-09-01

Last updated

2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PJI, Spondylodiscitis

Keywords

infections;, orthopedic surgery;, sensor;, PJI,, spondylodiscitis

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.

Interventions

DEVICEDevice

Use of the device in groups to test its ability to diagnose infections.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and Specificity	at enrollement	Most reliable cut-off evaluation in terms of best sensitivity and specificity of device in diagnosing PJI and spondylodiscitis

Countries

Italy

Contacts

Primary ContactRaffaele Vitiello, MD PhD

raffaele.vitiello@policlinicogemelli.it+39 - 0630151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026