NCT06891807

Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty

RobAR Study: Comparison of Image Based Robotic TKA vs Imageless Augmented Reality-Assisted TKA

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Medisch Centrum Latem · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study compares the accuracy of two different techniques in placing a total knee replacement. In one technique, accurate instrument placement is facilitated by a robot, and in the other technique, augmented reality is used for correct instrument placement. Both surgical techniques are already commonly used. During both the robotic technique and the augmented reality technique, the additional information (angles - axes) obtained during the operation is used to optimize the placement of the various prosthesis components. Patients that were recently diagnosed with advanced osteoarthritis of the knee can participate in this study. This means that the cartilage of the knee is affected by wear and tear. This causes pain, stiffness and swelling resulting in reduced mobility. When non-operative treatments are insufficient in treating the osteoarthritis, surgery is proposed wherein a knee arthroplasty is performed. The goal of this study is to further optimize and personalize patient care. Additionally, the aim of the study is to investigate whether both techniques are equivalent in optimally placing the prosthesis and whether both techniques lead to comparable results.

Conditions

• Knee Osteoarthritis
• Total Knee Arthroplasty\(TKA\)
• Total Knee Replacement Surgery

Interventions

Type	Name	Description
DEVICE	Robotics Assisted TKA	Skywalker Robotics Assisted TKA using Evolution Medial Pivot Knee
DEVICE	Augmented Reality assisted TKA	Pixee Knee+ assisted TKA using Evolution Medial Pivot Knee

Timeline

• Start date: 2024-07-18
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-03-24
• Last updated: 2025-03-24

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study