Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants
This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage).The main objective of this study is to collect short- and medium-term clinical data on the unicondylar knee prosthesis U-Knee / Uni-Kroma, in order to evaluate the performance of these implants.
| Condition(s) | Unicompartmental Knee Arthroplasty |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage).The main objective of this study is to collect short- and medium-term clinical data on the unicondylar knee prosthesis U-Knee / Uni-Kroma, in order to evaluate the performance of these implants. |
| Who can participate | Inclusion Criteria: \- All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme. Exclusion Criteria: * Patients who objected to participating in the study and the processing of their data * Patients unable to understand the surgeon's instructions to complete their questionnaires or perform postoperative follow-up * Patients who already have a unicompartmental prosthesis on the knee in question that need to be revised. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Societe dEtude, de Recherche et de Fabrication |
| Locations | Pierre-Bénite, France |
| Start date | 2023-01-01 |
| NCT ID | NCT05876143 |
| Official listing | https://clinicaltrials.gov/study/NCT05876143 |