Hip InfectionNCT06887816
Efficacy of New Silver-coated Prosthesis in Reducing the Incidence of Periprosthetic Infections
An observational study of Hip Infection, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Infection
- What is being tested?
- silver coated device and not silver coated device
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 2 sitesItaly
- Study dates
- 12 Mar 2025to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients aged ≥ 18 years;
- Immunocompromised patients and/or diabetic patients.
- Patients who have given consent
Who cannot join
- Patients aged < 18 years;
- Pregnant women;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Mazzolani Vandini
Argenta, Italia, 44011
Stefano Parro, MD, 0532 317827, s.parro@ausl.fe.it
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, BO, 40136
Matteo Romagnoli, MD, +390516366787, matteo.romagnoli@ior.it
Matteo Romagnoli, MD
About this study
Official title: Clinical Investigation of the Efficacy of New Silver-coated Prosthesis in Reducing the Incidence of Periprosthetic Infections
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.
Read the detailed 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.
- Conditions
- Hip Infection
- Being tested
- silver coated device, not silver coated device
- Keywords
- silver coating, primary prosthesis, second stage surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver coated deviceDevice
Patients who will be implanted with prosthesis with a silver coating to counteract infection relapse
not silver coated deviceDevice
Patients who will be implanted with prosthesis without silver coating
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: silver coated device; Device: not silver coated device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The clinical performance of the device through the performance of established clinical scores (Visual analogue scale).
Measured: 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
The clinical performance of the device through the performance of established clinical scores (Short form 36)
Measured: 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).
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start12 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip InfectionStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887816
- Sponsor's protocol ID
- Silver ProTect
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38474684Chen 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.
PubMed 36896412Shichman 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.
PubMed 36864906Tan 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.
PubMed 29715226Smolle 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.
PubMed 35906279Scoccianti 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.
PubMed 27523624
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Efficacy of New Silver-coated Prosthesis in Reducing the Incidence of Periprosthetic Infections
- ClinicalTrials.gov ID
- NCT06887816
- Acronym / sponsor ID
- Silver ProTect
- Conditions
- Hip Infection
- Keywords
- silver coating, primary prosthesis, second stage surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: silver coated device, Device: not silver coated deviceRevision 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Patients aged ≥ 18 years;
- Immunocompromised patients and/or diabetic patients.
- Patients who have given consent
Key exclusion criteria (2 listed)
- Patients aged < 18 years;
- Pregnant women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silver coated devicePatients who will be implanted with prosthesis with a silver coating to counteract infection relapse | Device | Patients |
| not silver coated devicePatients who will be implanted with prosthesis without silver coating | Device | Patients |
Primary outcome
Number of infections
Time frame: 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
Time frame: 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.
4 secondary outcomes
Clinical scores 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 38474684Akay 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.
- Background: PubMed 36896412Chen 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.
- Background: PubMed 36864906Shichman 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.
- Background: PubMed 29715226Tan 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.
- Background: PubMed 35906279Smolle 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.
- Background: PubMed 27523624Scoccianti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Infection, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Romagnoli, MD (+3905163666787, matteo.romagnoli@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infections (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06887816, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.