Status:
RECRUITING
Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
Lead Sponsor:
FH ORTHO
Collaborating Sponsors:
Slb Pharma
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06124482
Start Date
February 1 2024
End Date
February 1 2028
Last Update
June 19 2025
Active Locations (7)
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1
Hôpital Privé La Châtaigneraie
Beaumont, France, 63110
2
CHRU de la Cavale Blanche
Brest, France, 29200
3
Hôpital Beaujon AP-HP
Clichy, France, 92110
4
Hôpital Raymond Poincaré AP-HP
Garches, France, 92380