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Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range.

Knee Disease Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04578951
Study type Observational
Source FH ORTHO
Contact
Status Terminated
Phase
Start date September 28, 2020
Completion date March 30, 2023
View Details
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