Status:
RECRUITING
Safety and Effectiveness Evaluation of Spinal Laminectomy Robot
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
The Third Affiliated Hospital of Southern Medical University
The First Affiliated Hospital of Zhejiang Chinese Medical University
Conditions:
Lumbar Spinal Stenosis
Lumbar Disc Herniation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 safe...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06593574
Start Date
October 15 2024
End Date
December 30 2025
Last Update
October 22 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University Third Hospital
Beijing, China, 100101
2
Third Affiliated hospital of Southern medical university
Guangzhou, China
3
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, China