Clinical Research Directory
Browse clinical research sites, groups, and studies.
Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
Sponsor: Symbios Orthopedie SA
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
OBSERVATIONAL
Enrollment
264
Start Date
2023-10-11
Completion Date
2035-03-11
Last Updated
2024-10-04
Healthy Volunteers
No
Conditions
Interventions
HARMONY EVOLUTION
It is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices.
Locations (5)
Polyclinique de Franche-Comté
Besançon, France
Clinique Belledonne
Grenoble, France
Clinique Juge
Marseille, France
Clinique Arago
Paris, France
Médipôle Garonne
Toulouse, France