Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patient requiring knee arthroplasty for primary or secondary gonarthrosis: \* For primary intention arthroplasty: Patient with either * major axial deviation, * major peripheral failure or * bone defect; \* For prosthesis revision surgery: Patient who have had a failed 1st implantation, with or without bone defects. * Patient able to understand and answer the questionnaires provided by the protocol; * Subject affiliated to a health insurance system or is a beneficiary; * Signed informed consent form (ICF) for participation to the research. Exclusion Criteria: * Patient with an ongoing acute infection, outside knee to be operated; * Patient with a mental or neuromuscular disorder that would create an unacceptable risk of prosthetic instability, prosthetic fixation failure or post-operative complications; * Patient with a known allergy to any of the components of the FHK®-CK implants (Nickel, Cobalt, Chromium); * Patient with a dependency (drug, alcohol,…) that coul