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

Recruiting

• Conditions: Hip Infection

• Registration Number: NCT06887816
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study Start: 2025-03-12
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2027-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of infections	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.
Safety profile of silver	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 Outcome Measures

Name	Time	Method
Complications	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
Clinical scores 1	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).
Clinical scores 2	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)
Osteointegration	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).

Trial Locations

Locations (2)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy

Ospedale Mazzolani Vandini; 🇮🇹 Argenta, Italia, Italy