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

NCT06124482 | Recruiting DMC

• 1 other identifier: 2022-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 7

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 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.

Conditions

Total Knee Arthroplasty

Keywords

Complex primary Total Knee Arthroplasty; Revision Total Knee Arthroplasty; Functional performance; Safety evaluation

Outcome Measures

Primary Outcomes (1)

• Functional performance

  Evolution of the functional performance of FHK®-CK prosthesis using the KSS scoring system, which is composed of 2 sections : Knee score (KSKS) and function score (KSFS). Each section is scored on a scale of 0 to 100 ; the higher the score, the better the overall functionality of the knee. The functional performance of the FHK®-CK prosthesis will be demonstrated at 2 years if an improvement of the KSKS and KSFS scores at least equal to the Minimal Clinically Important Difference (MCID) values is observed.

  Baseline (preoperatively), at 6 weeks, 6 months, 12 months and 24 months after surgery.

Secondary Outcomes (8)

• Adverse and serious adverse events evaluation

  Through study completion, an average of 2 years

• Revision rate evaluation

  At 6 weeks, 6 months, 12 months and 24 months after surgery.

• Evaluation of patient's tolerance of the FHK-CK prosthesis

  At 6 weeks, 6 months, 12 months and 24 months after surgery.

• Device deficiencies evaluation

  Through study completion, an average of 2 years

• Quality of life assessment

  Baseline (preoperatively), at 6 months, 12 months and 24 months after surgery.

Study Arms (1)

Knee replacement

EXPERIMENTAL

Implantation of FHK-CK prosthesis either for a complex primary arthroplasty or for revision intend

Device: Total Knee arthroplasty

Interventions

Total Knee arthroplasty DEVICE

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.

Knee replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• FH ORTHO: lead
• Slb Pharma: collaborator

Study Sites (7)

Hôpital Privé La Châtaigneraie

Beaumont, 63110, France

TERMINATED

CHRU de la Cavale Blanche

Brest, 29200, France

RECRUITING

Hôpital Beaujon AP-HP

Clichy, 92110, France

RECRUITING

Hôpital Raymond Poincaré AP-HP

Garches, 92380, France

RECRUITING

CH d'Haguenau

Haguenau, 67500, France

RECRUITING

Centre Hospitalier Régional Universitaire de Nancy

Nancy, 54000, France

RECRUITING

Groupe Hospitalier Pitié Salpêtrière AP-HP

Paris, 75013, France

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Carole CARRÉ

CONTACT

06 40 47 16 71; c.carre@fhortho.com

Delphine KORNER

CONTACT

07 87 86 29 14; d.korner@fhortho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two target populations will be included in this clinical investigation : * 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.

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

FR (7)