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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Disc Herniation; Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Robotic laminectomy; Procedure: Traditional laminectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weishi Li, M.D.; Phone Number: (+86010)62017691-7011; Email: puh3liweishi@163.com
• Study Contact Backup: Name: Zhuofu Li, M.D.; Email: bjmulizhuofu@163.com

Study Locations

• China
  • Beijing, China, 100101
    • Recruiting
    • Peking University Third Hospital
    • Contact: Weishi Li, MD
  • Guangzhou, China
    • Not yet recruiting
    • Third Affiliated Hospital of Southern Medical University
    • Contact: Qingchu Li
  • Hangzhou, China
    • Not yet recruiting
    • Zhejiang Provincial Hospital of Chinese Medicine
    • Contact: Yu Qian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18-80 years old (including 18 and 80 years old), regardless of gender;
• Patients with complete clinical data, willing and able to sign informed consent;
• Patients with lumbar disc herniation, lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, and lumbar fracture meet the indications for spinal laminectomy and undergoing open surgery；

• Patients with lumbar disc herniation, lumbar spinal stenosis, or lumbar instability have one of the following:

  1. It was not effective after 3 months of conservative treatment
  2. Symptoms seriously affect the quality of life
  3. cauda equina nerve injury

• Lumbar spondylolisthesis occurs in one of the following:

  1. Symptoms of II° and below slip were not relieved by non-surgical treatment
  2. Lumbar spondylolisthesis III° and above
  3. Symptoms of lumbar spinal stenosis
• The TLISS score of lumbar spine fracture is greater than or equal to 4 points.

Exclusion Criteria:

• Patients who are not suitable for robot-assisted surgery;
• Patients with existing implants in or near the vertebral body of the lesion;
• Patients whose vertebral lamina bone tissue of the focal vertebra or adjacent vertebra has been removed;
• Pregnant and lactating female patients;
• the subject is unwilling or unable to restrict activities or follow medical advice;
• Patients with infection near the focal area;
• The patient is mentally incapable or unable to understand the requirements for participating in the study;
• The patient is critically ill, the expected survival period is not more than 2 years, and it is difficult to make an accurate assessment of the effectiveness and safety of the device;
• Patients with coagulation dysfunction;
• Other researchers did not consider it suitable for admission.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic laminectomy group; The laminectomy is performed with the assistance of a robot	Procedure: Robotic laminectomy; Surgical robots are used to assist with laminectomy
Active Comparator: Manual laminectomy group; The laminectomy is performed by the surgeon without the assistance of a robot	Procedure: Traditional laminectomy; Instead of relying on a surgical robot, doctors perform the laminectomy themselves with an ultrasonic osteotome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy rate of laminectomy	According to the classification criteria for the accuracy of laminectomy proposed by Zhuofu Li, grade A indicates that the pre-planned cutting lines are basically located in the actual cutting groove or that the maximum distance between them is <1mm; Grade B indicates that the maximum distance between the pre-planned cutting line and the actual cutting groove is 1 to 2mm. Grade C indicates a maximum distance of >2 mm between the two. Grades A and B are acceptable. The percentage of A+B in the total number of planned boundaries was counted as the accuracy rate of laminectomy.	Immediately after the intraoperative laminectomy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of laminectomy	After the laminectomy is complete, check whether the laminectomy can be successfully removed. Each cutting plane is evaluated individually.	Immediately after the intraoperative laminectomy procedure
Improvement rate of Japanese Orthopaedic Society (JOA) Score	The JOA score is a scoring system used to assess lumbar dysfunction. The lumbar JOA score includes subjective symptoms (9), clinical signs (6), limits of daily activities (14), and bladder function (-6 to 0) on a 29-point scale. The lower the score, the more significant the dysfunction. Improvement rate = [(post-treatment score - pre-treatment score)/(29 - pre-treatment score)] × 100%.	JOA scores were used to evaluate experimental and control subjects before and one month after surgery.
Visual analogue scale (VAS)	Visual analog scale, which indicates the degree of pain. The VAS score was used to evaluate the pain degree of the experimental group and control group.	Before and one month after the operation
Laminectomy time per spinal segment	Laminectomy time for a single spinal segment = total laminectomy time ÷ Number of spinal segments with laminectomy.	Immediately after surgery.
Total laminectomy time	The time from the start of laminectomy until the tool stops working is denoted as the total laminectomy time.	Immediately after surgery.
Operative time	From the time the skin is cut to the time the suture is finished.	Immediately after surgery.
Amount of surgical bleeding	Amount of surgical bleeding	Immediately after surgery.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: The Third Affiliated Hospital of Southern Medical University; The First Affiliated Hospital of Zhejiang Chinese Medical University
• Investigators: Principal Investigator: Weishi Li, M.D., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Laminectomy; Spinal robot
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Intervertebral Disc Displacement; Spinal Stenosis
• Other Study ID Numbers: D2024096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No