Evaluation of the 5C® MEDic Knee System
ConditionKnee Degenerative Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 5C® Knee System prothesis
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov