A Multicenter, Randomized, Blind Evaluation, Parallel-controlled, Superiority Clinical Trial of Spinal Robot System for Safety and Efficacy Evaluation of Assisted Laminectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Accuracy rate of laminectomy
研究概览
简要总结
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.
详细描述
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 assisting surgeons in laminectomy. The experiment included 3 centers with a total sample size of 70. The experimental group is the robot laminectomy group (RL group), and the control group is the manual laminectomy group (ML group). Laminectomy in the RL group is performed robotically, while laminectomy in the ML group is performed by the physician using an ultrasonic osteotome. The primary outcome measure is the accuracy of laminectomy. Secondary outcome measures included JOA score, VAS score, laminectomy success rate, laminectomy time per spinal segment, total laminectomy time, operative time, amount of surgical bleeding, number of X-ray exposures and total dose, and planned area excision rate. The evaluation was completed by comparing the outcomes between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Accuracy rate of laminectomy
时间窗: 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.
次要结局
- Success rate of laminectomy(Immediately after the intraoperative laminectomy procedure)
- Improvement rate of Japanese Orthopaedic Society (JOA) Score(JOA scores were used to evaluate experimental and control subjects before and one month after surgery.)
- Visual analogue scale (VAS)(Before and one month after the operation)
- Laminectomy time per spinal segment(Immediately after surgery.)
- Total laminectomy time(Immediately after surgery.)
- Operative time(Immediately after surgery.)
- Amount of surgical bleeding(Immediately after surgery.)