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 1stimplantation, 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 riskof prosthetic instability, prosthetic fixation failure or post-operativecomplications;
• 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 tocomply with the protocol, at the investigator's discretion;
• Patient requiring knee reconstruction;
• Patient with any medically significant findings or significant history that may impactthe safety, interpretation of results, and/ or participation of the subject in theclinical trial, as determined by the investigator;
• Patient with an existing knee or hip prosthesis (outside knee to be operated) that mayimpact the evaluation of the FHK®-CK prosthesis;
• Patient concurrently participating in another clinical trial or who has recentlyparticipated in another clinical trial for which the exclusion period has not beencompleted.
• Vulnerable subjects :
• Pregnant, parturient, or breastfeeding women,
• Subject deprived of liberty, hospitalized without consent or admitted to a healthor 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. forlinguistic or psychiatric reasons) and/or to give informed consent