Efficacy of New Silver-coated Prosthesis in Reducing the Incidence of Periprosthetic Infections
NCT ID: NCT06887816
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
70 participants
OBSERVATIONAL
2025-03-12
2029-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Immunocompromised patients and/or diabetic patients.
* Patients who have given consent
Exclusion Criteria
* Pregnant women;
18 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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Istituto Ortopedico Rizzoli
Bologna, BO, Italy
Ospedale Mazzolani Vandini
Argenta, Italia, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Silver ProTect
Identifier Type: -
Identifier Source: org_study_id
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