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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.
Despite significant advancements in total knee replacement surgery, patient-reported satisfaction rates remain around 80-90%. The native knee joint kinematics are driven by the asymmetric articular surfaces where the medial tibial plateau is concave while the lateral is convex. The C-shaped medial meniscus has anterior and posterior lips that resist translation while the lateral meniscus has a circular shape allowing for 15° of anterior to posterior motion and an 11 mm of translation. As the knee flexes, the medial femoral condyle has a static centre of rotation without anteroposterior translation while the lateral femoral condyle translates posteriorly resulting in relative internal rotation of the tibia around a medial pivot.
The design of medial pivot knee prosthesis closely replicates these native knee kinematics. The medial ball in-socket design offers a highly conforming implant resulting in low contact stress and minimal edge loading.
On the other hand, the lateral arcuate trough provides less conformity therefore facilitating posterior translation of the lateral contact point during flexion recreating the native posterior femoral rollback. Over recent years, the medial pivot knee arthroplasty has gained popularity with multiple studies reporting enhanced patients' reported outcomes compared to other designs. Despite the favourable outcomes reported in the literature, there is still lack of sufficient data in the literature regarding the reported patient's outcomes and the overall revision rate of these medial pivot designs.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving the 5C® MEDic Knee System | Experimental | Patients who will be operated at the Leuven University Hospital for a total knee arthroplasty and receive the 5C® MEDic Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5C® Knee System prothesis | Device | During the surgical intervention in this study, the 5C® Knee System prothesis is used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From Surgical intervention to end of study at 5 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
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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):
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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hazem Wafa, Dr. | Contact | +32 16 33 88 73 | hazem.wafa@uzleuven.be | |
| Anna Tarasiuk | Contact | +32 16 33 88 18 | orthopedie.research@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Hazem Wafa, Dr. | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen KU Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
Individual Participant Data (IPD) will not be shared with third parties to ensure de-identification and maintain strict patient confidentiality in accordance with the General Data Protection Regulation (GDPR). Due to the highly specific nature of complex primary and revision hip arthroplasty-sometimes involving rare congenital pathologies and unique skeletal deformities-sharing raw, granular data poses a significant risk of 'deductive re-identification.' Even without direct identifiers, the combination of rare clinical characteristics and surgical dates could potentially allow for the identification of individual patients. Therefore, only aggregated, pseudonymized data and statistical summaries will be provided for analysis and reporting.
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This post-market clinical follow-up (PMCF) study will focus on patients, who will be operated at the Leuven University Hospital and receive the 5C® MEDic Knee System
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| 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)) |
| 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). | 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)) |
| 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. | 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)) |
| 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:
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. | 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)) |
| Radiographic evaluation of the 5C® MEDic Knee System on X-ray images | The radiographic evaluation will be performed according to the "Knee Society Radiographic Evaluation System and Methodology for Total Knee Arthroplasty". The purpose of this scoring system is to accumulate radiographic data in a standardized manner to facilitate more accurate interpretation, documentation and clinical correlation. | From enrollment to a 1-year follow-up period (pre-operative, post-operative (6 weeks, 6 months, 1 year)) |
| Overwiew of complications and incidents during 5 years of follow-up | During surgery and the 5-year follow-up period the number and types of complications and incidents is collected. | 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)) |