performance and safety evaluation of the fhk®-ck knee prosthesis

Conditions: Total Knee Arthroplasty

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 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

Keywords: complex primary total knee arthroplasty revision total knee arthroplasty functional performance safety evaluation