Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628336
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-02
Brief Title:
Post-Market Observational Study of the HARMONY Evolution Implants and Instruments
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Post-Market Observational Study of the HARMONY Evolution Implants and Instruments
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Patients will be included in the study during 12 months and followed-up during 10 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None