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NCT Number: NCT06666023

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location status: Recruiting

Location contact

Raffaele Vitiello, MD PhD

CONTACT

[email protected]

+390630155701

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device

Device

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

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Raffaele Vitiello, MD PhD

CONTACT

[email protected]

+39 - 0630151

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Ministero della Salute, Italy

Registry information

Official study title

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

Acronym: Ortho-PoC

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 30, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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