Total Knee ArthroplastyFHK-CKNCT06124482
Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
A study testing Total Knee arthroplasty in people with Total Knee Arthroplasty, run by FH ORTHO at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Total Knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Feb 2024to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 6 recruiting
- Terminated
Hôpital Privé La Châtaigneraie
Beaumont, 63110
- Recruiting
CHRU de la Cavale Blanche
Brest, 29200
Frédéric DUBRANA, PhD
- Recruiting
Hôpital Beaujon AP-HP
Clichy, 92110
Marc-Antoine ROUSSEAU, PhD, marc-antoine.rousseau@aphp.fr
- Recruiting
Hôpital Raymond Poincaré AP-HP
Garches, 92380
Laurent VASTEL, PhD, laurent.vastel@aphp.fr
Fabien CALÉ, Dr
- Recruiting
CH d'Haguenau
Haguenau, 67500
Michel BRAX, Dr
Maroun RAAD, Dr
- Recruiting
Centre Hospitalier Régional Universitaire de Nancy
Nancy, 54000
Didier MAINARD, PhD, 0383851782 ext. 0033, didier.mainard@univ-lorraine.fr
- Recruiting
Groupe Hospitalier Pitié Salpêtrière AP-HP
Paris, 75013
Jean-Yves LAZENNEC, PhD, lazennec.jy@wanadoo.fr
About this study
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
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
- Being tested
- Total Knee arthroplasty
- Keywords
- Complex primary Total Knee Arthroplasty, Revision Total Knee Arthroplasty, Functional performance, Safety evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee arthroplastyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Knee replacement | Experimental | Implantation of FHK-CK prosthesis either for a complex primary arthroplasty or for revision intend Receives: Device: Total Knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preoperatively), at 6 weeks, 6 months, 12 months and 24 months after surgery.
Secondary outcomes (8)
Adverse and serious adverse events evaluation
Occurrence of adverse and serious adverse events, including complication
Measured: Through study completion, an average of 2 years
Revision rate evaluation
Revision rate
Measured: 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)
Measured: At 6 weeks, 6 months, 12 months and 24 months after surgery.
Device deficiencies evaluation
Number of device deficiencies and description of deficiencies.
Measured: 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".
Measured: 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)
Measured: 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)
Measured: 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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Feb 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FH ORTHO
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124482
- Sponsor's protocol ID
- 2022-01
- Acronym
- FHK-CK
- Status last verified
- Jun 2025
- First submitted
- 3 Nov 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06124482
- Acronym / sponsor ID
- FHK-CK / 2022-01
- Conditions
- Total Knee Arthroplasty
- Keywords
- Complex primary Total Knee Arthroplasty, Revision Total Knee Arthroplasty, Functional performance, Safety evaluation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- FH ORTHOIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Knee replacement | Experimental | Device: Total Knee arthroplastyImplantation of FHK-CK prosthesis either for a complex primary arthroplasty or for revision intend |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient requiring knee arthroplasty for primary or secondary gonarthrosis:
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee arthroplastyThe 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. | Device | Knee replacement |
Primary outcome
Functional performance
Time frame: Baseline (preoperatively), at 6 weeks, 6 months, 12 months and 24 months after surgery.
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.
8 secondary outcomes
Adverse and serious adverse events evaluation
Time frame: Through study completion, an average of 2 years
Revision rate evaluation
Time frame: At 6 weeks, 6 months, 12 months and 24 months after surgery.
Evaluation of patient's tolerance of the FHK-CK prosthesis
Time frame: At 6 weeks, 6 months, 12 months and 24 months after surgery.
Device deficiencies evaluation
Time frame: Through study completion, an average of 2 years
Quality of life assessment
Time frame: Baseline (preoperatively), at 6 months, 12 months and 24 months after surgery.
Quality of life assessment
Time frame: Baseline (preoperatively), at 6 months, 12 months and 24 months after surgery.
Patient's satisfaction about FHK®-CK prosthesis
Time frame: At 6 months, 12 months and 24 months after surgery
Surgeon's satisfaction about FHK®-CK equipment
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee arthroplasty in people with Total Knee Arthroplasty, run by FH ORTHO at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carole CARRÉ (06 40 47 16 71 ext. 0033, c.carre@fhortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional performance (time frame: Baseline (preoperatively), at 6 weeks, 6 months, 12 months and 24 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.