Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis

Launched by FH ORTHO · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new knee prosthesis called the FHK®-CK, designed for patients needing knee replacement surgery, either for the first time or as a revision after a previous surgery. The goal is to evaluate how well this prosthesis works and how safe it is for patients. Researchers are looking for participants aged 65 and older who require knee surgery due to issues like bone defects or past surgical failures. To participate, individuals must be able to understand and answer questions about their health and provide consent for the study.

Participants in the trial can expect to receive the FHK®-CK knee prosthesis, which has been developed with input from expert knee surgeons to ensure it is reliable and easy to use. The prosthesis aims to improve mobility and quality of life for patients. It's also designed to be compatible with existing prostheses, which can make the surgical process smoother and reduce risks. If you meet the eligibility criteria and are interested in participating, you will be helping to assess an innovative option for knee surgery that could benefit many people in need of this type of care.

Gender

ALL

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