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

Study acronym: Ortho-PoC
StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 30, 2024 (before its estimated September 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06666023
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators: Ministero della Salute, Italy
Conditions
(from sponsor)		 PJI, Spondylodiscitis
Related terms Discitis, Infections
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov