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

FH ORTHO

Status

Active, not recruiting

Conditions

Knee Disease

Treatments

Device: Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis

Study type

Observational

Funder types

Industry

Identifiers

NCT04221581

2018-38

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults subjects (≥18 years old).
Subject implanted with FHK ASYMETRIQUE prosthesis in one of the following indication according to the instructions for use: knee disorders; Aseptic condylar necrosis.
Subject who received an information form and is willing to participate in the study.

Exclusion criteria