NCT06124482

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: FH ORTHO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2023-11-09
• Last updated: 2025-06-19

Locations

7 sites across 1 country: France