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

F

FH ORTHO

Status

Enrolling

Conditions

Total Knee Arthroplasty

Treatments

Device: Total Knee arthroplasty

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06124482
2022-01

Details and patient eligibility

About

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.

Enrollment

92 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

92 participants in 1 patient group

Knee replacement
Experimental group
Description:
Implantation of FHK-CK prosthesis either for a complex primary arthroplasty or for revision intend
Treatment:
Device: Total Knee arthroplasty

Trial contacts and locations

5

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Central trial contact

Aroua JABRI; Stéphanie LHUILLIER

Data sourced from clinicaltrials.gov

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