Condition: Total Hip Replacement · Sponsor: Symbios Orthopedie SA
The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR. The objective is to demonstrate that the evaluated implants are compliant with the state of the art and the performance (PMA score \> 15 points) \& safety claims (The expected acceptable revision rate (state of the art with a confidence interval of 95%) is 3% at 3 years, 5% at 5 years, 7% at 7 years and 10% at 10 years). The endpoint of this study is to validate the expected performance of the HARMONY® Evolution implants with the PMA score at 10 years and to validate the safety claim with the expected acceptable revision rate at 10 years.
This description comes directly from the study's public registry record.
Bojana Gannevat · +41 24 424 26 26 · bojana.gannevat@symbios.ch
Always discuss trial participation with your own doctor first.
| Polyclinique de Franche-Comté | Besançon, France | Recruiting |
| Clinique Belledonne | Grenoble, France | Recruiting |
| Clinique Juge | Marseille, France | Recruiting |
| Clinique Arago | Paris, France | Recruiting |
| Médipôle Garonne | Toulouse, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06628336