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
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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.

Locations
Other Locations
Italy
Fondazione Policlinico Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Raffaele Vitiello, MD PhD
raffaele.vitiello@policlinicogemelli.it
+39 - 0630151
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 400
Treatments
Infection Group
Patients affected by PJI and Spondylodiscitis
Control Group
Patients with post-contusive or inflammatory or arthritic suffusion
Related Therapeutic Areas
Sponsors
Collaborators: Ministero della Salute, Italy
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov

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