Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06887816

Efficacy of New Silver-coated Prosthesis in Reducing the Incidence of Periprosthetic Infections

The aim of the present clinical study, of prospective observational nature with biological study, is to conduct a clinical investigation on the the efficacy of a device coated with bacteriostatic silver coating, with the overall objective of understand whether the device is indeed able to reduce the number of peri-operative and post-operative infections, both early and late.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli, Bologna, BO, Italy

Loading trial locations.

About this study

Among the various complications that can arise in orthopaedics following implant surgery, peri-prosthetic joint infections (Periprosthetic Joint Infection -PJI) represent one of the most feared complications and the main cause of revision surgeries (15% and 25% of hip and knee revision surgeries, respectively). In this complex context, prevention therefore plays a fundamental role and is a key objective considering the increasing number of patients considered to be at high risk such as the elderly, patients with recurrent infections (urinary, pulmonary, etc.), those suffering from diabetes mellitus or obese, the immunocompromised, or patients who have already undergone prosthetic surgery.

In order to reduce the risk of infection, it is therefore essential to adopt and implement preventive strategies that also involve the medical devices themselves, such as the development of passive surfaces capable of counteracting bacterial adhesion or active surfaces capable of exerting a direct action on micro-organisms. To achieve this second type of action, antibacterial agents, such as silver, known for its antimicrobial and bactericidal properties, are used.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged ≥ 18 years;
  • Immunocompromised patients and/or diabetic patients.
  • Patients who have given consent

Exclusion criteria

  • Patients aged < 18 years;
  • Pregnant women;

Treatment and study plan

silver coated device

Device

Patients who will be implanted with prosthesis with a silver coating to counteract infection relapse

not silver coated device

Device

Patients who will be implanted with prosthesis without silver coating

Primary outcomes

  1. Number of infections

    Time frame: at 1 month follow-up, at 3 months follow-up, at 6 months follow-up, at 12 months follow-up, at 24 months follow-up

    To evaluate the performance of the silver-coated device in reducing the incidence of early (occurring within 30 days of surgery) and late (occurring more than 90 days after surgery) infectious event in patients considered to be at high risk because they are awaiting primary prosthetic surgery but i) subject to recurrent occurrence of urinary pulmonary or other tract infections, (ii) immunocompromised, (iii) with rheumatic diseases, (iv) diabetics, or spacer carriers awaiting second-stage surgery for previous prosthetic revision due to infection.

  2. Safety profile of silver

    Time frame: day 0 (at baseline), at 6 months follow-up, at 12 months follow-up, at 24 months follow-up

    To assess the safety profile of device prosthesis system in terms of silver release. Blood sampling and urine sampling will be performed in enrolled patients prior to implantation of the device(baseline) and at selected follow-ups, to quantify and monitor for systemic Ag release from the prosthetic components. Samples will be appropriately processed and investigated by inductively coupled plasma-mass spectrometry (ICP-MS) analysis.

Secondary outcomes

  1. Clinical scores 1

    Time frame: day 0 (at baseline), at 1 month follow-up at 3 months follow-up, at 6 months follow-up, at 12 months follow-up, at 24 months follow-up

    The clinical performance of the device through the performance of established clinical scores (Visual analogue scale).

  2. Clinical scores 2

    Time frame: day 0 (at baseline), at 1 month follow-up at 3 months follow-up, at 6 months follow-up, at 12 months follow-up, at 24 months follow-up

    The clinical performance of the device through the performance of established clinical scores (Short form 36)

  3. Osteointegration

    Time frame: at 1 month follow-up at 3 months follow-up, at 6 months follow-up, at 12 months follow-up, at 24 months follow-up

    The stability and osseointegration of the device through the evaluation of radiological images at different follow-ups (1, 3, 6, 12 and 24 months).

  4. Complications

    Time frame: at 1 month follow-up, at 3 months follow-up, at 6 months follow-up, at 12 months follow-up, at 24 months follow-up

    The occurrence of possible early and late post-implantation complications

Study contacts

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

Maria Sartori, Phd

CONTACT

[email protected]

+390516366787

Matteo Romagnoli, MD

CONTACT

[email protected]

+3905163666787

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Clinical Investigation of the Efficacy of New Silver-coated Prosthesis in Reducing the Incidence of Periprosthetic Infections

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Mar 20, 2025
Registry last updated
May 4, 2026

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.

Published trials that share one or more normalized conditions with this study.