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

NCT06887816 | Recruiting

• 1 other identifier: Silver ProTect
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Infection

Keywords

silver coating; primary prosthesis; second stage surgery

Outcome Measures

Primary Outcomes (2)

• Number of infections

  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.

  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

• Safety profile of silver

  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.

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

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Patients

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.

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

Interventions

silver coated device DEVICE

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

Patients

not silver coated device DEVICE

Patients who will be implanted with prosthesis without silver coating

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Revision patients with a history of previous infection awaiting access to 'second-stage' surgery or patients awaiting primary prosthetic surgery with recurrent urinary, pulmonary or other infections will be enrolled

You may qualify if:

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

You may not qualify if:

• Patients aged \< 18 years;
• Pregnant women;

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (2)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

RECRUITING

Ospedale Mazzolani Vandini

Argenta, Italia, 44011, Italy

RECRUITING

Related Publications (6)

• Akay S, Yaghmur A. Recent Advances in Antibacterial Coatings to Combat Orthopedic Implant-Associated Infections. Molecules. 2024 Mar 6;29(5):1172. doi: 10.3390/molecules29051172.

  PMID: 38474684 BACKGROUND

• Chen X, Zhou J, Qian Y, Zhao L. Antibacterial coatings on orthopedic implants. Mater Today Bio. 2023 Feb 15;19:100586. doi: 10.1016/j.mtbio.2023.100586. eCollection 2023 Apr.

  PMID: 36896412 BACKGROUND

• Shichman I, Roof M, Askew N, Nherera L, Rozell JC, Seyler TM, Schwarzkopf R. Projections and Epidemiology of Primary Hip and Knee Arthroplasty in Medicare Patients to 2040-2060. JB JS Open Access. 2023 Feb 28;8(1):e22.00112. doi: 10.2106/JBJS.OA.22.00112. eCollection 2023 Jan-Mar.

  PMID: 36864906 BACKGROUND

• Tan TL, Maltenfort MG, Chen AF, Shahi A, Higuera CA, Siqueira M, Parvizi J. Development and Evaluation of a Preoperative Risk Calculator for Periprosthetic Joint Infection Following Total Joint Arthroplasty. J Bone Joint Surg Am. 2018 May 2;100(9):777-785. doi: 10.2106/JBJS.16.01435.

  PMID: 29715226 BACKGROUND

• Smolle MA, Bergovec M, Scheipl S, Gossler W, Amerstorfer F, Glehr M, Leithner A, Friesenbichler J. Long-term changes in serum silver concentrations after extremity reconstruction with silver-coated megaprostheses. Sci Rep. 2022 Jul 29;12(1):13041. doi: 10.1038/s41598-022-16707-0.

  PMID: 35906279 BACKGROUND

• Scoccianti G, Frenos F, Beltrami G, Campanacci DA, Capanna R. Levels of silver ions in body fluids and clinical results in silver-coated megaprostheses after tumour, trauma or failed arthroplasty. Injury. 2016 Oct;47 Suppl 4:S11-S16. doi: 10.1016/j.injury.2016.07.042. Epub 2016 Aug 11.

  PMID: 27523624 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood draw and urine sample will be collected at the baseline and at the follow-ups (6, 12 and 24 months) for the quantification of silver content with ICP-MS analysis.

Central Study Contacts

Matteo Romagnoli, MD

CONTACT

+3905163666787; matteo.romagnoli@ior.it

Maria Sartori, Phd

CONTACT

+390516366787; maria.sartori@ior.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 20, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

IT (2)