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

Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis Indicated for the Treatment of Primary and Secondary First Line Gonarthrosis and Revision Arthroplasty - 2 Years Follow-up - A Pilot Study

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.

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