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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.
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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 :
Primary purpose
Allocation
Interventional model
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92 participants in 1 patient group
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Central trial contact
Stéphanie LHUILLIER; Aroua JABRI
Data sourced from clinicaltrials.gov
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