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

Active, not recruiting

• Conditions: Knee Disease
• Interventions: Device: Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis

• Registration Number: NCT04221581
• Lead Sponsor: FH ORTHO

Brief 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.

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-09
• Study Start: 2020-01-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22
• Primary Completion: 2034-01-22
• Study Completion: 2034-01-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 43

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

• Contraindications described in the instructions for use
• Usual surgical contraindications
• Patients objecting to participate in this study
• Subject who is not able to express his/her non-opposition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving FHK ASYMETRIQUE prosthesis	Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis	-

Primary Outcome Measures

Name	Time	Method
Safety evaluation	10 years post-op	Survival rate

Secondary Outcome Measures

Name	Time	Method
Radiological evaluation	preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op	Radiological results such as stability, osteointegration will be evaluated. The HKA angle will be measured. It is the angle (in degrees) between the center of the femoral head, the center of the knee and the center of the tibio-fibular mortise. This radiological evaluation is a usual assessment used in the follow-up of patients operated for a total knee replacement.
Rate of complications	peroperative, 3 months postoperative, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op	All complications will be gathered during intervention and up to 10 years postoperatively.
Functional outcomes such as pain, mobility.	preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op	Functional outcomes will be determined by the IKS score. New IKS score range from 0 to 200 with a physical score on 100 points (pain, knee's mobility, abnormal laxity, flexion deformity and Hips knee Ankle) and a functional score on 100 points (walking distance, difficulty with stairs and use of walking aids).

Trial Locations

Locations (3)

Clinique Mutualiste de la Porte de l'Orient; 🇫🇷 Lorient, France

CH Pasteur; 🇫🇷 Colmar, France

Médipôle Garonne; 🇫🇷 Toulouse, France