BridgeMD
Tests treatment safety and results for Total Knee Arthroplasty
Official title Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
ClinicalTrials.gov ID: NCT06124482
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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;
You likely can't join 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...
- 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...
See the full eligibility 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.
- 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 people :
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beaumont, France
- Brest, France
- Clichy, France
- Garches, France
- Haguenau, France
- Nancy, France
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beaumont, France; Brest, France; Clichy, France; Garches, France; Haguenau, France; Nancy, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.