Evaluation of the 5C® MEDic Knee System (NCT07491575) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the 5C® MEDic Knee System
Belgium100 participantsStarted 2026-04
Plain-language summary
This prospective study wants to demonstrate the safety and clinical performance of the 5C® MEDic Knee System following total knee arthroplasty. Additionally, all observed product-related complications are documented during the course of the follow-up study. These observations help to re-assess current (known) risks and identify new ones. The data obtained during this study is part of the post market surveillance.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Voluntary written informed consent of the participant has been obtained prior to any screening procedures
✓. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
✓. The patient will be operated at the Leuven University Hospital (primary or revision surgery).
✓. The patient will receive the 5C® MEDic Knee System (manufactured by implantcast GmbH).
✓. The implantation will be performed according to the medical indications listed in the product specific Instruction for Use (IFU):
✓. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
✓. Post-traumatic osteoarthritis
✓. Treatment of fractures that are unmanageable using other surgical techniques
Exclusion criteria
✕. The patient is \<18 years of age, or unable to understand and sign a written informed consent form or legally incompetent or limited in his legal capacity.
✕. Patient has history of malignancy within the past 5 years before screening.
✕. Patients with Adipositas permagna (BMI ≥40 kg/m²).
✕. Has a current infection as well as infections close (in the opinion of the investigator) to the knee joint within the last 3 years.
What they're measuring
1
Revision rate after the 5C® MEDic Knee System
Timeframe: From Surgical intervention to end of study at 5 years post-operative