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

FH ORTHO

Status: Terminated

Conditions: Knee Disease

Treatments: Device: FHK® total knee prosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT04578951

2018-41

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject implanted with FHK® 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.
• Adults subjects (≥18 years old).
• Access to an internet connection allowing to complete the questionnaires on the online platform

Exclusion criteria

• Contraindications described in the instructions for use
• Subject who is not able to express his/her non-opposition

Trial design

50 participants in 1 patient group

Patients receiving a prosthesis from the FHK® range

Treatment:

Device: FHK® total knee prosthesis