Evaluation of the FHK4-CK Knee Prosthesis for Complex and Revision Knee Replacement Surgery with 2-Year Follow-Up

What this Trial Is About

Researchers are evaluating the FHK-CK knee prosthesis designed for complex first-time and revision knee replacement surgeries, addressing the growing need due to increasing life expectancy and the widespread use of total knee arthroplasty. This device aims to complement the existing FHK standard prosthesis range, providing surgeons with a versatile and reliable option to improve patient mobility and quality of life. The study is a pilot evaluation focusing on performance and safety with a follow-up period of two years. The study involves implanting the FHK-CK prosthesis, which is a class III medical device not yet CE-marked, along with specialized instruments developed by expert surgeons. The prosthesis is intended for patients with primary or secondary gonarthrosis requiring complex knee arthroplasty or revision surgery after a failed first implant. Surgery will be conducted following established guidelines and specific instructions for the device, with assessments at multiple time points up to 24 months after implantation. Participants will be assessed for functional performance before surgery and at 6 weeks, 6 months, 12 months, and 24 months post-surgery. Additional evaluations include monitoring adverse events, revision rates, device deficiencies, patient and surgeon satisfaction, and quality of life at scheduled intervals. The study also ensures participants can understand and respond to questionnaires, with outcomes tracked over approximately two years to determine the prosthesiss tolerance and overall impact.

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