RecruitingNot ApplicableNCT06593574

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

Sponsor

Peking University Third Hospital

Enrollment

70 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

Lumbar Spinal Stenosis Lumbar Disc Herniation

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria12

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:
It was not effective after 3 months of conservative treatment
Symptoms seriously affect the quality of life
cauda equina nerve injury
Lumbar spondylolisthesis occurs in one of the following:
Symptoms of II° and below slip were not relieved by non-surgical treatment
Lumbar spondylolisthesis III° and above
Symptoms of lumbar spinal stenosis
The TLISS score of lumbar spine fracture is greater than or equal to 4 points.

Exclusion Criteria10

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.