Actively Recruiting
Safety and Effectiveness Evaluation of Spinal Laminectomy Robot
Led by Peking University Third Hospital · Updated on 2024-10-22
70
Participants Needed
3
Research Sites
63 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
T
The Third Affiliated Hospital of Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness Evaluation of Spinal Laminectomy Robot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-80 years old (including 18 and 80), any gender
- Patients with complete clinical data who are willing and able to sign informed consent
- Patients diagnosed with lumbar disc herniation, lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, or lumbar fracture who meet surgical indications for spinal laminectomy
- Patients with lumbar disc herniation, spinal stenosis, or instability who have either not improved after 3 months of conservative treatment, have symptoms seriously affecting quality of life, or have cauda equina nerve injury
- Patients with lumbar spondylolisthesis who have symptoms of grade II or below slip unrelieved by non-surgical treatment, grade III or above spondylolisthesis, or symptoms of lumbar spinal stenosis
- Patients with lumbar spine fractures with a TLISS score of 4 points or higher
You will not qualify if you...
- Patients unsuitable 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 or adjacent vertebra has been removed
- Pregnant or lactating female patients
- Patients unwilling or unable to restrict activities or follow medical advice
- Patients with infection near the surgical area
- Patients mentally incapable or unable to understand study requirements
- Critically ill patients with expected survival less than 2 years, making assessment difficult
- Patients with coagulation dysfunction
- Patients deemed unsuitable for admission by other researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Peking University Third Hospital
Beijing, China, 100101
Actively Recruiting
2
Third Affiliated hospital of Southern medical university
Guangzhou, China
Not Yet Recruiting
3
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, China
Not Yet Recruiting
Research Team
W
Weishi Li, M.D.
CONTACT
Z
Zhuofu Li, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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