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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-22

Study Completion Date

2034-01-22

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.

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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.

Conditions

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Knee Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving FHK ASYMETRIQUE prosthesis

Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis

Intervention Type 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.

Interventions

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Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No