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RECRUITING
NCT06124482
NA

Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis

Sponsor: FH ORTHO

View on ClinicalTrials.gov

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

Interventions

DEVICE

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