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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silver coated device | Device | Patients who will be implanted with prosthesis with a silver coating to counteract infection relapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical scores 1 | The clinical performance of the device through the performance of established clinical scores (Visual analogue scale). | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matteo Romagnoli, MD | Contact | +3905163666787 | matteo.romagnoli@ior.it | |
| Maria Sartori, Phd | Contact | +390516366787 | maria.sartori@ior.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | BO | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38474684 | Background | 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. | |
| 36896412 | 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. |
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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.
| not silver coated device | Device | Patients who will be implanted with prosthesis without silver coating |
|
The clinical performance of the device through the performance of established clinical scores (Short form 36) |
| 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 | The stability and osseointegration of the device through the evaluation of radiological images at different follow-ups (1, 3, 6, 12 and 24 months). | 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 | The occurrence of possible early and late post-implantation 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 |
| Ospedale Mazzolani Vandini | Recruiting | Argenta | Italia | 44011 | Italy |
|
| 36864906 | 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. |
| 29715226 | 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. |
| 35906279 | 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. |
| 27523624 | 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. |