Clinical trial NCT06124482: Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Complex primary Total Knee Arthroplasty
Revision Total Knee Arthroplasty
Functional performance
Safety evaluation
Lead sponsor: FH ORTHO
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2023-11-09
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Functional performance
timeFrame: Baseline (preoperatively), at 6 weeks, 6 months, 12 months and 24 months after surgery.
Secondary outcomes:
measure: Adverse and serious adverse events evaluation
timeFrame: Through study completion, an average of 2 years
measure: Revision rate evaluation
timeFrame: At 6 weeks, 6 months, 12 months and 24 months after surgery.
measure: Evaluation of patient's tolerance of the FHK-CK prosthesis
timeFrame: At 6 weeks, 6 months, 12 months and 24 months after surgery.
measure: Device deficiencies evaluation
timeFrame: Through study completion, an average of 2 years
measure: Quality of life assessment
timeFrame: Baseline (preoperatively), at 6 months, 12 months and 24 months after surgery.
measure: Quality of life assessment
timeFrame: Baseline (preoperatively), at 6 months, 12 months and 24 months after surgery.
measure: Patient's satisfaction about FHK®-CK prosthesis
timeFrame: At 6 months, 12 months and 24 months after surgery
measure: Surgeon's satisfaction about FHK®-CK equipment
timeFrame: During surgery
Other outcomes:
Locations:
city: Beaumont
country: France
facility: Hôpital Privé La Châtaigneraie
city: Clichy
country: France
facility: Hôpital Beaujon AP-HP
city: Garches
country: France
facility: Hôpital Raymond Poincaré AP-HP
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière AP-HP
Study officials:
References: