Protocol for evaluation of robotic technology in orthopedic surgery

Area of Science:

• Robotics in Surgery
• Orthopedic Surgery
• Medical Device Technology

Background:

• Robotic systems are increasingly utilized in surgical procedures for enhanced precision.
• The Acrobot Sculptor is a robotic system designed to assist with unicompartmental knee replacement surgeries.
• Clinical validation of robotic systems is crucial for patient safety and surgical success.

Purpose of the Study:

• To evaluate the clinical accuracy of the Acrobot Sculptor robot for unicompartmental knee replacement.
• To assess the performance of the robot's software and hardware components in a real-world surgical setting.

Main Methods:

• Segmentation accuracy was compared between Acrobot Sculptor software and commercial alternatives.
• Registration accuracy was assessed by evaluating inter- and intraobserver repeatability of landmark point selection.
• Sculpting accuracy was evaluated in nine cases by comparing planned implant position and orientation with the achieved results.

Main Results:

• Segmentation and registration processes demonstrated high accuracy.
• Mean compound rotational and translational errors for tibial and femoral components were within acceptable ranges (e.g., 2.1 ± 0.6 mm and 3 ± 0.8° for tibia).
• The highest observed error was 0.4 ± 3.7° in the flexion-extension orientation of the femoral implant.

Conclusions:

• The Acrobot Sculptor robot exhibits small errors across all evaluated processes, indicating reliable performance in clinical settings.
• Clinical validation of robotic surgical systems is essential for ensuring positive patient outcomes.
• The methodology used in this study is recommended for validating similar robotic systems.