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Clinical Trials/NCT06666023
NCT06666023
Recruiting
Not Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country400 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PJI
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
400
Locations
1
Primary Endpoint
Sensitivity and Specificity
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
September 1, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sensitivity and Specificity

Time Frame: at enrollement

Most reliable cut-off evaluation in terms of best sensitivity and specificity of device in diagnosing PJI and spondylodiscitis

Study Sites (1)

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