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Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
Sponsor: FH ORTHO
Summary
The life expectancy worldwide is increasing and leading to an increase of knee arthroplasty. Also, as millions of people around the world are currently living with a Total Knee Arthroplasty (TKA), the need for revision surgery represents a large public health burden. In this context, FH ORTHO company develops FHK®-CK (prosthesis + ancillary equipment) which is a knee prosthesis for complex first intention and revision knee arthroplasty. This new medical device complements the FHK® standard first-line range (CE marked). The FHK®-CK ancillary equipment were designed by expert knee surgeons and is simple, reliable and reproducible. It allows for maximum versatility while remaining compact. By completing the FHK® range of first intention prostheses, the FHK®-CK allows the surgeon to be on the same level as the competitors by having a first intention and semi-constrained prosthesis. This prosthetic arsenal allows the surgeon to opt for the best solution for his patient so that he can regain mobility and a satisfactory quality of life. Also, in case of failure of the FHK® first-line prosthesis, it will provide the surgeon and the patient with a simple alternative to prosthesis replacement. As it has been developed in line with the first intention, inter-compatibility between the two systems is possible, which simplifies the surgical procedure and reduces the risks for the patient.
Official title: Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis Indicated for the Treatment of Primary and Secondary First Line Gonarthrosis and Revision Arthroplasty - 2 Years Follow-up - A Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2024-02-01
Completion Date
2028-02
Last Updated
2025-06-19
Healthy Volunteers
No
Conditions
Interventions
Total Knee arthroplasty
The FHK-CK prosthesis (non CE-Marked, class III) is to be implanted with the use of FHK-CK instruments. The surgery has to be performed in accordance with the practice/guidelines, FHK-CK Instruction For Use (IFU) and surgical techniques documents.
Locations (7)
Hôpital Privé La Châtaigneraie
Beaumont, France
CHRU de la Cavale Blanche
Brest, France
Hôpital Beaujon AP-HP
Clichy, France
Hôpital Raymond Poincaré AP-HP
Garches, France
CH d'Haguenau
Haguenau, France
Centre Hospitalier Régional Universitaire de Nancy
Nancy, France
Groupe Hospitalier Pitié Salpêtrière AP-HP
Paris, France