Multigen Plus H Study and AMF TT Cones
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.
| Condition(s) | Arthroplasty, Replacement, Knee |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Limacorporate S.p.a |
| Locations | Ghent, Belgium; Bratislava, Slovakia |
| Start date | 2022-01-19 |
| NCT ID | NCT04884542 |
| Official listing | https://clinicaltrials.gov/study/NCT04884542 |