Actively Recruiting

Age: 18Years +
All Genders
NCT06666023

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-10-30

400

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

F

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead Sponsor

M

Ministero della Salute, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Gemelli IRCCS

Rome, Lazio, Italy, 00168

Actively Recruiting

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Research Team

R

Raffaele Vitiello, MD PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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