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Clinical Trials in France / NCT04221581
Active, not recruiting Observational

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

NCT04221581 · tracked via the Priya Life Science France tracker
Sponsor
FH ORTHO
Phase
Observational
Started
2020-01-22
Last updated
2024-02-22

Condition(s) studied

Knee Disease

Investigational drug(s) / intervention(s)

Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
CH Pasteur Colmar France
Clinique Mutualiste de la Porte de l'Orient Lorient France
Médipôle Garonne Toulouse France

More FH ORTHO trials in France

FH ORTHO Shoulder Observatory Recruiting
Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis Recruiting
Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove® Active, not recruiting
FH ORTHO SAS Knee Observatory Starting soon
Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04221581 on ClinicalTrials.gov ↗ ← All trials in France