Evaluation of the FHK®-CK Knee Prosthesis for Knee Replacement
Official title: 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
Run by Fh Ortho · NCT06124482 · Data updated 2026-11-12
This study is testing a new knee replacement device to see if it works well and is safe for patients with complex knee issues or those who have had previous surgeries.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | Fh Ortho Industry-sponsored |
| Locations | 7 sites (Beaumont and 6 other locations) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | June 19, 2025 |
| Trial ID | NCT06124482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients requiring knee arthroplasty for primary or secondary gonarthrosis, especially those with major bone defects or previous failed surgeries.
✕Probably not a fit
Patients with ongoing acute infections, mental or neuromuscular disorders, or known allergies to the prosthesis components may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the performance and safety of the FHK®-CK knee prosthesis designed for complex primary and revision total knee arthroplasty. The prosthesis, developed by FH ORTHO, aims to address the needs of patients requiring knee replacement due to significant bone defects or previous surgical failures. The study will involve patients who meet specific criteria and will assess functional performance and safety outcomes through standardized questionnaires and clinical evaluations. The FHK®-CK system is designed to provide surgeons with a versatile and reliable option for knee arthroplasty.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing knee replacement surgeries, particularly those with complex needs.
How similar studies have gone: Other studies have shown success with similar prosthetic approaches, indicating potential for positive outcomes with this new device.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHRU de la Cavale Blanche
Brest, France Recruiting -
Hôpital Beaujon AP-HP
Clichy, France Recruiting -
Hôpital Raymond Poincaré AP-HP
Garches, France Recruiting -
CH d'Haguenau
Haguenau, France Recruiting -
Centre Hospitalier Régional Universitaire de Nancy
Nancy, France Recruiting -
Groupe Hospitalier Pitié Salpêtrière AP-HP
Paris, France Recruiting
Show 1 more location
-
Hôpital Privé La Châtaigneraie
Beaumont, France Terminated
Study contacts
- Study coordinator: Carole CARRÉ
- Email: c.carre@fhortho.com
- Phone: 06 40 47 16 71
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.