Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
NCT ID: NCT06124482
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
92 participants
INTERVENTIONAL
2024-02-01
2028-02-29
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
* 60 patients requiring primary Total Knee Arthroplasty
* 32 patients requiring revision Knee Arthroplasty.
In this clinical investigation, it was not possible to realize a double-blinding for practical reasons. Nevertheless, a collection of the primary outcome (score KSS) will be realized blindly to the surgeon in charge of the patient by an intervener not involved in the medical care of the patient, who did not participate in the intervention and did not collect the preoperative KSS score.
OTHER
NONE
Study Groups
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Knee replacement
Implantation of FHK-CK prosthesis either for a complex primary arthroplasty or for revision intend
Total Knee arthroplasty
The FHK-CK prosthesis (non CE-Marked, class III) is to be implanted with the use of FHK-CK instruments. The surgery has to be performed in accordance with the practice/guidelines, FHK-CK Instruction For Use (IFU) and surgical techniques documents.
Interventions
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Total Knee arthroplasty
The FHK-CK prosthesis (non CE-Marked, class III) is to be implanted with the use of FHK-CK instruments. The surgery has to be performed in accordance with the practice/guidelines, FHK-CK Instruction For Use (IFU) and surgical techniques documents.
Eligibility Criteria
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Inclusion Criteria
\* 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 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
18 Years
ALL
No
Sponsors
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Slb Pharma
OTHER
FH ORTHO
INDUSTRY
Responsible Party
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Locations
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Hôpital Privé La Châtaigneraie
Beaumont, , France
CHRU de la Cavale Blanche
Brest, , France
Hôpital Beaujon AP-HP
Clichy, , France
Hôpital Raymond Poincaré AP-HP
Garches, , France
CH d'Haguenau
Haguenau, , France
Centre Hospitalier Régional Universitaire de Nancy
Nancy, , France
Groupe Hospitalier Pitié Salpêtrière AP-HP
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Frédéric DUBRANA, PhD
Role: primary
Michel BRAX, Dr
Role: primary
Other Identifiers
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2022-01
Identifier Type: -
Identifier Source: org_study_id
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