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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving FHK ASYMETRIQUE prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis | Device | FHK ASYMETRIQUE prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation | Survival rate | 10 years post-op |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from participating hospitals will be enrolled as part of their clinical routine care
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Pasteur | Colmar | 68000 | France | |||
| Clinique Mutualiste de la Porte de l'Orient |
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| 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 |
| Lorient |
| 56324 |
| France |
| Médipôle Garonne | Toulouse | 31036 | France |