Safety and Effectiveness Evaluation of Spinal Laminectomy Robot
- Conditions
- Lumbar Spinal StenosisLumbar Disc Herniation
- Registration Number
- NCT06593574
- Lead Sponsor
- Peking University Third Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria:<br><br> - Patients aged 18-80 years old (including 18 and 80 years old), regardless of gender;<br><br> - Patients with complete clinical data, willing and able to sign informed consent;<br><br> - Patients with lumbar disc herniation, lumbar spinal stenosis, lumbar instability,<br> lumbar spondylolisthesis, and lumbar fracture meet the indications for spinal<br> laminectomy and undergoing open surgery;<br><br> - Patients with lumbar disc herniation, lumbar spinal stenosis, or lumbar instability<br> have one of the following:<br><br> 1. It was not effective after 3 months of conservative treatment<br><br> 2. Symptoms seriously affect the quality of life<br><br> 3. cauda equina nerve injury<br><br> - Lumbar spondylolisthesis occurs in one of the following:<br><br> 1. Symptoms of II° and below slip were not relieved by non-surgical treatment<br><br> 2. Lumbar spondylolisthesis III° and above<br><br> 3. Symptoms of lumbar spinal stenosis<br><br> - The TLISS score of lumbar spine fracture is greater than or equal to 4 points.<br><br>Exclusion Criteria:<br><br> - Patients who are not suitable for robot-assisted surgery;<br><br> - Patients with existing implants in or near the vertebral body of the lesion;<br><br> - Patients whose vertebral lamina bone tissue of the focal vertebra or adjacent<br> vertebra has been removed;<br><br> - Pregnant and lactating female patients;<br><br> - the subject is unwilling or unable to restrict activities or follow medical advice;<br><br> - Patients with infection near the focal area;<br><br> - The patient is mentally incapable or unable to understand the requirements for<br> participating in the study;<br><br> - The patient is critically ill, the expected survival period is not more than 2<br> years, and it is difficult to make an accurate assessment of the effectiveness and<br> safety of the device;<br><br> - Patients with coagulation dysfunction;<br><br> - Other researchers did not consider it suitable for admission.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy rate of laminectomy
- Secondary Outcome Measures
Name Time Method Success rate of laminectomy;Improvement rate of Japanese Orthopaedic Society (JOA) Score;Visual analogue scale (VAS);Laminectomy time per spinal segment;Total laminectomy time;Operative time;Amount of surgical bleeding