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

NCT06666023 | Recruiting DMC

• 1 other identifier: PNRR-POC-2023-12378291
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

PJI; Spondylodiscitis

Keywords

infections;; orthopedic surgery;; sensor;; PJI,; spondylodiscitis

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

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

  at enrollement

Study Arms (2)

Infection Group

Patients affected by PJI and Spondylodiscitis

Device: Device

Control Group

Patients with post-contusive or inflammatory or arthritic suffusion

Device: Device

Interventions

Device DEVICE

Use of the device in groups to test its ability to diagnose infections.

Control Group; Infection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 may not qualify if:

• pregnant women,
• patient affected by cancer
• patient under antibiotic therapy

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Ministero della Salute, Italy: collaborator

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Discitis; Infections

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Spondylitis; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Study Officials

• Giulio Maccauro

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Vitiello, MD PhD

CONTACT

+39 - 0630151; raffaele.vitiello@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-09

Locations

IT (1)