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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
5C® Knee System prothesis
DeviceDuring the surgical intervention in this study, the 5C® Knee System prothesis is used.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Patients receiving the 5C® MEDic Knee SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Revision rate after the 5C® MEDic Knee System
The Implant Survival of the 5C® MEDic Knee System prothesis is determined by the amount of revisions during the follow-up period of 5 years. The question, if a revision is performed after the surgical intervention, can be answered with "yes" or "no". Also, how long the prosthesis remains in place without the need for a second operation (revision) is recorded (in years).
Time frame
From Surgical intervention to end of study at 5 years post-operativeSecondary outcomes
1
EQ-5D-3L health questionnaire as clinical performance assessment
This questionnaire is used in this study to assess the clinical performance of the 5C® MEDic Knee System during 5 years of follow-up. The questionnaire will evaluate mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Every topic can be answered with "No", "Moderate", "not able to/Extreme". Additionally, patients provide a self-assessment of their overall health using a Visual Analogue Scale (VAS) from 0 to 100, where 0 represents the "worst health imaginable" and 100 represents the "best health imaginable."
Time frame
From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))2
Forgotten Joint Score questionnaire (FJS-12) as clinical performance assessment
This questionnaire is used in this study to assess the clinical performance of the 5C® MEDic Knee System during 5 years of follow-up. The questionnaire will evaluate "joint/prothesis awareness" during activities of daily living after total knee arthroplasty, meaning to which extent a patient is aware of their prosthetic joint. The questionnaire consists of 12 items, each rated on a 5-point scale (0-4). The total score is transformed to a 0-100 scale, where a higher score indicates a better outcome (i.e., the patient is less aware of the artificial joint).
Time frame
From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))3
High-Flexion Knee Score questionnaire as clinical performance assessment
This questionnaire is used in this study to assess the clinical performance of the 5C® MEDic Knee System during 5 years of follow-up. The questionnaire will evaluate lifestyle activities that require deep knee flexion. This questionnaire assesses the patient's ability to perform functional tasks such as kneeling, squatting, and sitting cross-legged. The HFKS consists of several items categorized into functional domains, where higher scores represent superior clinical performance and greater ease in performing high-flexion movements.
Time frame
From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))4
Knee Society Score questionnaire as clinical performance assessment
This questionnaire is used in this study to assess the clinical performance of the 5C® MEDic Knee System during 5 years of follow-up. The Knee Society Score (KSS) is a assessment tool used to evaluate the outcomes of total knee arthroplasty (TKA). It consists of four distinct subscales: 1. Objective Knee Score (completed by the surgeon, measuring alignment and ligament stability) 2. Patient Satisfaction Score (measuring how happy the patient is with the outcome) 3. Patient Expectation Score (measuring if the surgery met preoperative goals) 4. Functional Activity Score (assessing walking, stair climbing, and advanced activities). This approach-combining objective clinical data with patient-reported outcomes-provides a comprehensive overview of the prosthesis's performance and its impact on the patient's quality of life.
Time frame
From enrollment to the end of the study, following a 5-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year, 3 years and 5 years))Sponsors and contacts
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Source ClinicalTrials.gov