AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - anyAllFH ORTHO
💬

In plain words

What the trial is, and whether it could suit you

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 pr

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
💊

What it tests

  • Total Knee arthroplasty
📍

Where

7 sites
Hôpital Privé La Châtaigneraie
Beaumont, France
CHRU de la Cavale Blanche
Brest, France
Hôpital Beaujon AP-HP
Clichy, France
Hôpital Raymond Poincaré AP-HP
Garches, France
CH d'Haguenau
Haguenau, France
Centre Hospitalier Régional Universitaire de Nancy
Nancy, France
Groupe Hospitalier Pitié Salpêtrière AP-HP
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy