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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

not silver coated device: Patients who will be implanted with prosthesis without silver coating

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (2)

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