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The goal of this observational study is to evaluate the infection control and mid-term survival of silver-coated articulated megaprosthetic and knee arthrodesis implants in PJI patients with bone stock deficiency and treated with two-stage protocol.
The majority of studies investigating the outcomes of silver-coated megaprostheses have evaluated case histories of megaprostheses in oncologic patients, while there is little evidence in the Literature of the outcomes of silver-coated megaprostheses in the treatment of infections in non-oncologic patients.
Knowing the mid- to long-term results of this type of implant is of great importance to inform the patient regarding expectations after surgery.
Obtaining more results and data on the treatment of knee PJI with silver-coated megaprostheses could pave the way for the design of prospective randomized comparative trials aimed at establishing the gold standard of treatment.
It is a nonprofit, observational, cohort, retrospective and prospective, multicenter, national study. Patients will be treated according to clinical practice in accordance with the judgment of the clinician.
The biographical and clinical-radiographic data that will be collected are:
All data and clinical and radiographic material will be collected together and analyzed at IRCCS Azienda Ospedaliero Universitaria di Bologna. All radiographic measurements will be performed by 3 independent operators after evaluation of intra- and inter-observer reliability on 10 random patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Infection status | absence of clinical radiological and/or laboratory signs of infection or infected. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications unrelated to prosthesis infection in the two different stages of the protocol, also analyzing the number of "first stage" repetitions | Number and type of non-infection-related complications of "first-stage" within 8 weeks and "second-stage" within 24 months | Within 8 weeks and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated at the Orthopedics and Traumatology Operating Unit of IRCCS Azienda Ospedaliero Universitaria di Bologna, Policlinico di S.Orsola and other national centers between January 2020 and December 2024 with silver-coated knee megaprosthesis in the two-stage treatment of knee PJI.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Sambri, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy | ||
| Azienda Ospedaliero Universitaria Careggi |
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| Florence |
| Florence |
| 50134 |
| Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Pisa | 56126 | Italy |