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

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 could affect his/ her ability to comply with the protocol, at the investigator's discretion;
* Patient requiring knee reconstruction;
* Patient with any medically significant findings or significant history that may impact the safety, interpretation of results, and/ or participation of the subject in the clinical trial, as determined by the investigator;
* Patient with an existing knee or hip prosthesis (outside knee to be operated) that may impact the evaluation of the FHK®-CK prosthesis;
* Patient concurrently participating in another clinical trial or who has recently participated in another clinical trial for which the exclusion period has not been completed.
* Vulnerable subjects :

  * Pregnant, parturient, or breastfeeding women,
  * Subject deprived of liberty, hospitalized without consent or admitted to a health or social establishment for purposes other than that of research,
  * Minor,
  * Adult under protective supervision (tutorship, curatorship),
  * Subject not able to understand the subject information leaflet (e.g. for linguistic or psychiatric reasons) and/or to give informed consent