A Clinical Application Study of Mixed Reality Technology Assisted Lumbar Pedicle Screws Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The Standard Of Gertzbein-Robbins
研究概览
简要总结
Prospective comparative study of Mixed Reality Technology（MR）assisted lumbar pedicle screws placement and traditional lumbar pedicle screws placement.
详细描述
In this study, the randomized controlled method was adopted to prospectively include the samples, and the differences in surgical procedures and efficacy were compared between the thoracolumbar pedicle screw implantation assisted by MR and the traditional thoracolumbar pedicle screw implantation, so as to provide a plan for clinicians to choose the surgical method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 38 Years 至 53 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Course of disease≥6 months, all patients with lumbago back pain, radiation pain of lower limbs, lumbar disc herniation diagnosed with or without spinal stenosis.
- •The course of disease≥6 months, all patients had lumbar back pain, accompanied by or without intermittent claudication, and the diagnosis of lumbar spondylolisthesis was clear, but the vertebral isthmus was not broken.
- •The patient's symptoms were consistent with the imaging examination results, failed to respond to conservative treatment, and met the surgical indications.
- •The lesion segment is no more than 3 vertebral bodies.
- •Preoperative improvement of X-ray, CT, MRI examination.
- •Patients without active bleeding and female patients is not in menstrual period.
排除标准
- •Lumbar acute infection, lumbar tuberculosis, tumor and other diseases.
- •Patients with severe cardiopulmonary insufficiency, intolerance to surgery, diabetes and poor blood glucose control, combined with coagulation dysfunction and other contraindications.
- •Vertebral fracture patients.
- •Bone Mineral Density (BMD) examination: BMD was measured by dual-energy X- ray absorptiometry at the lumbar spine (L2 ~ L4) and femoral head, and BMD and T values were observed. Abnormal bone mass were excluded according T >- 1 SD
研究组 & 干预措施
Lumbar pedicle screws implantation of traditional procedure
traditional method of lumbar pedicle screws implantation
干预措施: Mixed Reality technology (Device)
结局指标
主要结局
The Standard Of Gertzbein-Robbins
时间窗: 1 day
the standard of Gertzbein-Robbins :Ⅰ, self-contained complete within the pedicle nail; Ⅱ, self-contained nail through 2 mm below the cortex; Ⅲ, self-contained nail through 2 mm or greater, cortex \< 4 mm; Nail through 4 mm or higher cortex; Ⅳ, self-contained, \< 6 mm; Ⅴ, self-contained nail through 6 mm or higher cortex.
Visual Analog Scale
时间窗: 6 months
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Oswestry Disability Index
时间窗: 6 months
Oswestry Disability Index is for movement function, Questionnaire examines
次要结局
未报告次要终点