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)
Accuracy rate of laminectomy — Immediately after the intraoperative laminectomy procedure 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.
Trial sites (3)
Facility
City
Region
Status
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
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.
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