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Clinical Trials in China / NCT06593574
Recruiting Not applicable

Safety and Effectiveness Evaluation of Spinal Laminectomy Robot

NCT06593574 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Third Hospital
Phase
Not applicable
Started
2024-10-15
Last updated
2024-10-22

Condition(s) studied

Lumbar Spinal StenosisLumbar Disc Herniation

Investigational drug(s) / intervention(s)

Robotic laminectomyTraditional laminectomy

Robotic laminectomy: Surgical robots are used to assist with laminectomy

Traditional laminectomy: Instead of relying on a surgical robot, doctors perform the laminectomy themselves with an ultrasonic osteotome

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Peking University Third Hospital Beijing China Recruiting
Third Affiliated hospital of Southern medical university Guangzhou China Not Yet Recruiting
Zhejiang Provincial Hospital of Chinese Medicine Hangzhou China Not Yet Recruiting

More Peking University Third Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06593574 on ClinicalTrials.gov ↗ ← All trials in China