NCT04221581

Study Conducted on Patients Operated With a FHK ASYMETRIQUE to Confirm Security and Performance of the Device

Prospective Observational Clinical Study Conducted on Patient Operated With a Total Knee Prosthesis FHK ASYMETRIQUE to Confirm Security and Performance of the Device Over a Period of 10 Years

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: FH ORTHO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when used in real life conditions according to the instructions for use.

Detailed description

The primary objective of this study is to evaluate the security of the FHK ASYMETRIQUE prosthesis by calculating the survival rate up to 10 years of follow-up. The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score up to 10 years of follow-up.

Conditions

• Knee Disease

Interventions

Type	Name	Description
DEVICE	Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis	FHK ASYMETRIQUE prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function.

Timeline

• Start date: 2020-01-22
• Primary completion: 2034-01-22
• Completion: 2034-01-22
• First posted: 2020-01-09
• Last updated: 2024-02-22

Locations

3 sites across 1 country: France