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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Known allergy to any of the implant materials.
. Female who is pregnant or intends to become pregnant during screening and at the moment of operation
. Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, as assessed by the Investigator.
. Current alcohol and/or drug abuse or other addictions that might impair the patient's capacity to estimate the nature and the scope of the study.