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

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Hip Infection

Treatments: Device: not silver coated device; Device: silver coated device

Study type: Observational

Funder types: Other

Identifiers

NCT06887816

Silver ProTect

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

70 participants in 1 patient group

Patients

Description:

Revision patients with outcomes of previous infection awaiting access to "second-stage" surgery or patients awaiting primary prosthetic surgery with recurrent urinary, pulmonary or other district infections.

Treatment:

Device: silver coated device

Device: not silver coated device