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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
92
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.
Hôpital Privé La Châtaigneraie
Beaumont, France
TERMINATEDCHRU de la Cavale Blanche
Brest, France
RECRUITINGHôpital Beaujon AP-HP
Clichy, France
RECRUITINGHôpital Raymond Poincaré AP-HP
Garches, France
RECRUITINGCH d'Haguenau
Haguenau, France
RECRUITINGCentre Hospitalier Régional Universitaire de Nancy
Nancy, France
RECRUITINGGroupe Hospitalier Pitié Salpêtrière AP-HP
Paris, France
RECRUITINGFunctional 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.
Time frame: Baseline (preoperatively), at 6 weeks, 6 months, 12 months and 24 months after surgery.
Adverse and serious adverse events evaluation
Occurrence of adverse and serious adverse events, including complication
Time frame: Through study completion, an average of 2 years
Revision rate evaluation
Revision rate
Time frame: At 6 weeks, 6 months, 12 months and 24 months after surgery.
Evaluation of patient's tolerance of the FHK-CK prosthesis
Tolerance assessed by the surgeon with a 4-Likert scale (very bad - bad - good - very good)
Time frame: At 6 weeks, 6 months, 12 months and 24 months after surgery.
Device deficiencies evaluation
Number of device deficiencies and description of deficiencies.
Time frame: Through study completion, an average of 2 years
Quality of life assessment
Self assessement of quality of life using the medical outcome study Short Form (SF-12) scale (General Quality of life score) from 0 "worst quality of life" to 100 "best quality of life".
Time frame: Baseline (preoperatively), at 6 months, 12 months and 24 months after surgery.
Quality of life assessment
Self assessement of quality of life using the Oxford Knee score (OKS), especially developed for knee surgery. The OKS is derived from 12 questions assessed on a Likert scale with values from 0 to 4; a summative score is then calculated where 48 is the best possible score (least symptomatic) and 0 is the worst possible score (most symptomatic)
Time frame: Baseline (preoperatively), at 6 months, 12 months and 24 months after surgery.
Patient's satisfaction about FHK®-CK prosthesis
Satisfaction assessed by the patient with a 4-Likert scale ((very bad - bad - good - very good)
Time frame: At 6 months, 12 months and 24 months after surgery
Surgeon's satisfaction about FHK®-CK equipment
Satisfaction assessed by the surgeon for each surgery performed with FHK®-CK with a specific questionnaire developed including 9 questions with either a lickert scale or a yes/no response.
Time frame: During surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.