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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hôpital Privé La Châtaigneraie
TERMINATED
Beaumont
CHRU de la Cavale Blanche
RECRUITING
Brest
Hôpital Beaujon AP-HP
RECRUITING
Clichy
Hôpital Raymond Poincaré AP-HP
RECRUITING
Garches
CH d'Haguenau
RECRUITING
Haguenau
Centre Hospitalier Régional Universitaire de Nancy
RECRUITING
Nancy
Groupe Hospitalier Pitié Salpêtrière AP-HP
RECRUITING
Paris
Contact Information
Primary
Carole CARRÉ
c.carre@fhortho.com
06 40 47 16 71
Backup
Delphine KORNER
d.korner@fhortho.com
07 87 86 29 14
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2028-02
Participants
Target number of participants: 92
Treatments
Experimental: Knee replacement
Implantation of FHK-CK prosthesis either for a complex primary arthroplasty or for revision intend
Related Therapeutic Areas
Sponsors
Leads: FH ORTHO
Collaborators: Slb Pharma

This content was sourced from clinicaltrials.gov