NCT07491575

Evaluation of the 5C® MEDic Knee System

Evaluation of the Midterm Results of the 5C® MEDic Knee System

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Knee Degenerative Disease

Interventions

Type	Name	Description
DEVICE	5C® Knee System prothesis	During the surgical intervention in this study, the 5C® Knee System prothesis is used.

Timeline

• Start date: 2026-04-01
• Primary completion: 2035-04-01
• Completion: 2035-04-01
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: Belgium