Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT04578951
Status:
TERMINATED
Last Update Posted:
2023-11-07
First Post:
2020-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range.
Sponsor:
FH ORTHO
Organization:
Study Overview
Official Title:
Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range and Followed for 2 Years.
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Only 19% of the expected patients have been enroled. Patient's follow-up has not been realized as expected in the protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance with the approved instructions for use.
This study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.
This study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.
Detailed Description:
The primary objective of this study is to evaluate the quality of life in patients operated with a FHK® total knee prosthesis up to 2 years of follow-up.
The secondary objectives are to evaluate the security and performance of the devices by gathering complications, revision rate of the devices (survival analysis) and functional score up to 2 years of follow-up.
The secondary objectives are to evaluate the security and performance of the devices by gathering complications, revision rate of the devices (survival analysis) and functional score up to 2 years of follow-up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: