What is the FHK-CK knee prosthesis studying for knee arthroplasty?

This trial is studying the performance and safety of the FHK-CK knee prosthesis in patients undergoing complex primary or revision knee replacement surgery. Researchers want to understand how well the device works and how it affects patient recovery and quality of life. The study is sponsored by FH ORTHO, the company developing the prosthesis.

Who may be eligible for this total knee arthroplasty clinical trial?

Adults aged 18 years and older who require knee arthroplasty for primary or secondary gonarthrosis may be eligible. The trial accepts all genders and requires participants to be able to understand questionnaires and have health insurance. People with active infections, allergies to implant materials, or certain medical conditions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this total knee arthroplasty clinical trial?

Study-related care, including the prosthesis implantation and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06124482

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

Led by FH ORTHO · Updated on 2025-06-19

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient requires knee arthroplasty for primary or secondary gonarthrosis
For primary arthroplasty: presence of major axial deviation, major peripheral failure, or bone defect
For revision surgery: previous failed first implantation, with or without bone defects
Patient can understand and answer study questionnaires
Patient is affiliated with a health insurance system or is a beneficiary
Signed informed consent form for study participation

You will not qualify if you...

Ongoing acute infection outside the knee to be operated
Mental or neuromuscular disorder risking prosthetic instability or complications
Known allergy to nickel, cobalt, or chromium components of the implant
Dependency (drug, alcohol, etc.) affecting protocol compliance
Need for knee reconstruction
Medically significant condition impacting safety or study participation
Existing knee or hip prosthesis on the opposite knee affecting evaluation
Concurrent or recent participation in another clinical trial within exclusion period
Vulnerable subjects including pregnant or breastfeeding women, minors, those deprived of liberty or under protective supervision, or unable to understand the study information and consent process

Research Team

Carole CARRÉ

Delphine KORNER

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