Actively Recruiting
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
Eligibility Criteria
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.
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
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Gemelli IRCCS
Rome, Lazio, Italy, 00168
Actively Recruiting
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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