NCT06628336

Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 264 (estimated)
• Sponsor: Symbios Orthopedie SA · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is prospective, multi-centric, observational, non-comparative, non-randomized and post market. About 264 subjects will be enrolled in this study to evaluate the safety and performance of the HARMONY® Evolution implants. Patients will be included in the study during 12 months and followed-up during 10 years.

Conditions

• Total Hip Replacement

Interventions

Type	Name	Description
DEVICE	HARMONY EVOLUTION	It is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices.

Timeline

• Start date: 2023-10-11
• Primary completion: 2034-10-11
• Completion: 2035-03-11
• First posted: 2024-10-04
• Last updated: 2024-10-04

Locations

5 sites across 1 country: France