NCT06887816

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Infection

Interventions

Type	Name	Description
DEVICE	silver coated device	Patients who will be implanted with prosthesis with a silver coating to counteract infection relapse
DEVICE	not silver coated device	Patients who will be implanted with prosthesis without silver coating

Timeline

• Start date: 2025-03-12
• Primary completion: 2027-03-01
• Completion: 2029-03-01
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

2 sites across 1 country: Italy