Paper-based Electrochemical Point-of-care Device in Diagnostic of Orthopedic Infections (Ortho-PoC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spondylodiscitis; PJI
• Intervention / Treatment: Device: Device

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Raffaele Vitiello, MD PhD; Phone Number: +39 - 0630151; Email: raffaele.vitiello@policlinicogemelli.it

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Gemelli IRCCS
      • Contact: Raffaele Vitiello, MD PhD; Phone Number: +390630155701; Email: raffaele.vitiello@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with a suspected history of PJI or spondylodiscitis according to international guidelines and subsequent diagnostic confirmation of infection.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infection Group; Patients affected by PJI and Spondylodiscitis	Device: Device; Use of the device in groups to test its ability to diagnose infections.
Control Group; Patients with post-contusive or inflammatory or arthritic suffusion	Device: Device; Use of the device in groups to test its ability to diagnose infections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity	Most reliable cut-off evaluation in terms of best sensitivity and specificity of device in diagnosing PJI and spondylodiscitis	at enrollement

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Collaborators: Ministero della Salute, Italy
• Investigators: Principal Investigator: Giulio Maccauro, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: spondylodiscitis; infections;; orthopedic surgery;; sensor;; PJI,
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Infectious; Spinal Diseases; Spondylitis; Infections; Discitis
• Other Study ID Numbers: PNRR-POC-2023-12378291

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No