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

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