NCT06593574

Safety and Effectiveness Evaluation of Spinal Laminectomy Robot

A Multicenter, Randomized, Blind Evaluation, Parallel-controlled, Superiority Clinical Trial of Spinal Robot System for Safety and Efficacy Evaluation of Assisted Laminectomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the effectiveness and safety of this spinal robot in assisting doctors to perform laminectomy in spinal surgery under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial.

Detailed description

This is a multicenter, randomized, blind evaluation, parallel-controlled, and superiority clinical trial. The objective of this study is to evaluate the effectiveness and safety of a spinal robot in assisting surgeons in laminectomy. The experiment included 3 centers with a total sample size of 70. The experimental group is the robot laminectomy group (RL group), and the control group is the manual laminectomy group (ML group). Laminectomy in the RL group is performed robotically, while laminectomy in the ML group is performed by the physician using an ultrasonic osteotome. The primary outcome measure is the accuracy of laminectomy. Secondary outcome measures included JOA score, VAS score, laminectomy success rate, laminectomy time per spinal segment, total laminectomy time, operative time, amount of surgical bleeding, number of X-ray exposures and total dose, and planned area excision rate. The evaluation was completed by comparing the outcomes between the two groups.

Conditions

• Lumbar Spinal Stenosis
• Lumbar Disc Herniation

Interventions

Type	Name	Description
PROCEDURE	Robotic laminectomy	Surgical robots are used to assist with laminectomy
PROCEDURE	Traditional laminectomy	Instead of relying on a surgical robot, doctors perform the laminectomy themselves with an ultrasonic osteotome

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-09-19
• Last updated: 2024-10-22

Locations

3 sites across 1 country: China