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

N/AActive Not RecruitingNCT04221581

FH ORTHO43 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Knee Disease

Interventions

Knee prosthesis - FHK ASYMETRIQUE total knee prosthesisDEVICE

FHK ASYMETRIQUE prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

CH Pasteur

Colmar, France

Clinique Mutualiste de la Porte de l'Orient

Lorient, France

Médipôle Garonne

Toulouse, France

Outcomes

Primary Outcomes

Safety evaluation

Survival rate

Time frame: 10 years post-op

Secondary Outcomes

Radiological evaluation

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.

Time frame: preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op

Rate of complications

All complications will be gathered during intervention and up to 10 years postoperatively.

Time frame: peroperative, 3 months postoperative, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op

Functional outcomes such as pain, mobility.

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).

Time frame: preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op

Data from ClinicalTrials.gov

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