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 unacceptablerisk of 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 mayimpact the safety, interpretation of results, and/ or participation of the subjectin the clinical trial, as determined by the investigator;

• Patient with an existing knee or hip prosthesis (outside knee to be operated) thatmay impact 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 ahealth 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. forlinguistic or psychiatric reasons) and/or to give informed consent