Evaluation of the 5C® MEDic Knee System
Evaluation of the Midterm Results of the 5C® MEDic Knee System
Universitaire Ziekenhuizen KU Leuven
100 participants
Jul 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria12
- 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
- Rheumatoid arthritis
- Revision arthroplasty (revision prosthesis)
- The patient is willing and able to follow all study specific procedures and to attend the follow-up visits at the study site
- The patient agrees to be contacted by telephone or by mail.
Exclusion Criteria18
- 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.
- Bilateral Total Knee Arthroplasty in a period of < 3 months.
- Physiological or anatomical conditions, which preclude or are not expected to maintain adequate bony support of the implant or do not allow the implantation of a sufficiently large prosthesis, in the opinion of the investigator.
- Bone tumors in the implant fixation area.
- Has an untreated vascular diseases which limit blood supply to the affected limb, in the opinion of the investigator
- Has a metabolic disorders that may impair bone formation.
- In case of insufficient quantity and quality of bone stock, an alternative prosthetic treatment allowing for sufficient bony fixation should be considered.
- Has severe axis deviation in treated knee under study and/or non-treated knee.
- Ligament instability in treated knee under study.
- Participation in an interventional trial with an investigational medicinal product (IMP) or device within the last four weeks before Screening.
- Any other clinical history finding that, in the judgment of the investigator, would pose a potential hazard for performing a knee surgery
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Interventions
During the surgical intervention in this study, the 5C® Knee System prothesis is used.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07491575