Arthroplasty, Replacement, Knee
Conditions
Brief summary
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.
Interventions
DEVICERevision Total Knee Arthroplasty
Total Knee Arthroplasty in case of failure of a previous operation.
Sponsors
North American Science Associates Ltd.
Limacorporate S.p.a
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * Age ≥ 18 years old * Given written informed consent approved by the reference Ethics Committee (EC) * Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with the Multigen Plus H system as per Indication For Use. The decision to implant a Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned. * Subject is able to comply with the protocol
Exclusion criteria
* Age < 18 years old * Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus H, as reported in the current Instruction For Use. * Any clinically significant pathology based on the medical history or any medical intervention that the Investigator feels may affect the study evaluation * Female subjects who are pregnant, nursing, or planning a pregnancy * Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS < 70 points.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Knee Society Score (KSS) | Month 24 | Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS-ADL (Function in Daily Living subdomain) | Month 24 | Evaluation of the functional changes in the KOOS-ADL domain after revision TKA |
| VAS Pain score | Month 24 | Evaluation of the changes in the VAS Pain score after revision TKA |
| Survivorship of the implant | Month 24 | Kaplan-Meier estimate |
| Radiographic implant evaluation and stability assessment | Month 24 | Evaluation of progressive Radiolucent Lines after revision TKA |
| Safety evaluation | Intra-operatively, Month 3, Month 12, and Month 24 | Incidence, type, and severity of all the Adverse Events (AEs) occurred after revision TKA |
Countries
Belgium, Slovakia
Contacts
Primary ContactFrancesca Citossi
Backup ContactMagalì Mafucci
Outcome results
None listed