Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
ConditionTotal Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFH ORTHO
About this trial
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
This trial does not accept healthy volunteersQualifiers
major axial deviation,
major peripheral failure or
bone defect;
Patient able to understand and answer the questionnaires provided by the protocol;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Total Knee arthroplasty
DeviceThe 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.
Treatment groups
92 Participants
are divided into 1 treatment groupGroup A: Knee replacementExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (preoperatively), at 6 weeks, 6 months, 12 months and 24 months after surgery.Secondary outcomes
1
Adverse and serious adverse events evaluation
Occurrence of adverse and serious adverse events, including complication
Time frame
Through study completion, an average of 2 years2
Revision rate evaluation
Revision rate
Time frame
At 6 weeks, 6 months, 12 months and 24 months after surgery.3
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.4
Device deficiencies evaluation
Number of device deficiencies and description of deficiencies.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
FH ORTHO
Lead sponsor
Slb Pharma
Collaborator
Source ClinicalTrials.gov