Robot-assisted Percutaneous Endoscopic Posterior/Transforaminal Lumbar Interbody Fusion for Lumbar Spinal Stenosis With Instability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pain visual analog scale (VAS)
研究概览
简要总结
Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 who present with intermittent claudication accompanied by lower back pain, lumbar spine MRI and/or CT findings of lumbar spinal stenosis, and X-ray images of over extension and over flexion indicating instability of the responsible segment of the lumbar spine, have severe symptoms that affect daily life and work, and have poor conservative treatment results. Therefore, RPE-P/TLIF single segment or double segment surgical treatment is recommended.
排除标准
- •(1) Simple lumbar spinal stenosis without responsible segment instability; (2) Long segment (3 or more) spinal stenosis with lumbar instability; (3) Patients with major internal medicine underlying diseases who cannot tolerate surgery; (4) Individuals with comorbid mental disorders or Alzheimer's disease who are unable to cooperate with relevant scale filling and subsequent follow-up; (5) Age<18 years old.
结局指标
主要结局
Pain visual analog scale (VAS)
时间窗: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Pain assessment, assessing lower back pain and lower limb pain.
次要结局
- intervertebral space height(Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery)
- Oswestry disability index (ODI)(Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery)
- MacNab criteria(Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery)
- lumbar physiological curvature(Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery)
- fusion rate(Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery)
- pedicle screw accuracy(Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery)
研究者
Wen-xi Sun
Clinical Professor
Guangzhou University of Chinese Medicine