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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Knee Disease

Intervention / Treatment
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* Device: Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving FHK ASYMETRIQUE prosthesis<br> | Device: Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis<br>* FHK ASYMETRIQUE prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation | Survival rate | 10 years post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Knee, Replacement