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| Name | Class |
|---|---|
| North American Science Associates Ltd. | NETWORK |
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The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revision Total Knee Arthroplasty | Device | Total Knee Arthroplasty in case of failure of a previous operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Knee Society Score (KSS) | Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS-ADL (Function in Daily Living subdomain) | Evaluation of the functional changes in the KOOS-ADL domain after revision TKA | Month 24 |
| VAS Pain score | Evaluation of the changes in the VAS Pain score after revision TKA |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population for this study includes adult subjects in whom the decision to perform a Total Knee Arthroplasty with Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to include the subject into the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Citossi | Contact | +39 335 164026 | francesca.citossi@limacorporate.com | |
| Magalì Mafucci | Contact | +39 3316082095 | magali.mafucci@limacorporate.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Jan Palfijn Gent | Recruiting | Ghent | 9000 | Belgium |
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| Month 24 |
| Survivorship of the implant | Kaplan-Meier estimate | Month 24 |
| Radiographic implant evaluation and stability assessment | Evaluation of progressive Radiolucent Lines after revision TKA | Month 24 |
| Safety evaluation | Incidence, type, and severity of all the Adverse Events (AEs) occurred after revision TKA | Intra-operatively, Month 3, Month 12, and Month 24 |
| Nemocnica Bory - Penta Hospital | Not yet recruiting | Bratislava | 625J+3P | Slovakia |
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