Comparing Migration and Wear of Cruciate Retaining and Condylar Stabilizing Inserts in Robot-Assisted Uncemented Total Knee Replacement with 10-Year Follow-Up

What this Trial Is About

Researchers are comparing two types of inserts used in total knee replacement surgery the Condylar Stabilizing CS insert and the Cruciate Retaining CR insert, both made from highly cross-linked polyethylene HXPLE. This study focuses on patients under 70 years old undergoing primary total knee arthroplasty TKA with an intact posterior cruciate ligament PCL. The goal is to evaluate differences in implant migration, wear, and clinical outcomes over a long-term period of up to 10 years. During surgery, patients receive either an uncemented TKA with the CS insert or the CR insert, both implanted using a MAKO robotic arm and a kinematic balancing technique. Tantalum markers are also placed in the bone to measure implant movement using model-based roentgen stereophotogrammetric analysis mRSA. These markers and the marker inserters safety and usability will be assessed as part of the study. Participants will be followed for 10 years with regular evaluations of implant migration, wear, inducible displacement, and survival. Clinical outcomes will be measured using various scores including the Knee Society Score, pain rating scales, and quality of life assessments. Safety monitoring includes tracking complications related to the tantalum markers and the surgical procedure. This long-term follow-up aims to provide detailed information on the performance and safety of these knee replacement inserts.

Migration of CS vs CR Insert in TKA Using RSA