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临床试验/NCT04254757
NCT04254757Unknown不适用

Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

Lumbar spinal stenosis (LSS) is the most common spinal degenerative disease. For conservative treatment failure, open lumbar decompression and fusion surgery is the main surgical treatment. After decades of development, open lumbar decompression and fusion surgery has been the standard treatment. However, there are still people and conditions that cannot be covered, such as elderly people who intolerable surgery, severe osteoporosis, and re-stenosis at adjacent segments after fusion. Percutaneous spinal endoscopic lumbar spinal decompression technique could be performed under local anesthesia, soft tissue damage is minimized, and effective spinal decompression can be achieved. There are still some controversial points of LSS decompression under percutaneous endoscope surgery, such as the range of decompression, choice of approach, postoperative spinal stability, learning curve, surgical safety, long-term effects of endoscopic treatment of restenosis at adjacent segments after fusion surgery. The purpose of this study was to solve these controversial points. A multi-center, prospective registration study based on the real world is planned. The total sample size is about 600 cases (300 cases in endoscopic surgery group, 300 cases in open decompression and fusion group). The mid- to long-term clinical efficacy and safety were evaluated.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with symptomatic lumbar canal stenosis(including central canal, lateral recess, foraminal and extraforaminal) despite more than 6 weeks of conservative treatment; Pathology was confirmed by both computed tomography and magnetic resonance imaging The operative level≤2

排除标准

  • Segmental instability Simple disc herniation Coexisting pathological conditions, such as tumor and infection

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: at 1 years after surgery

VAS of leg and back

Modified MacNab criteria

时间窗: 1 years after surgery

Oswestry Disability Index(ODI)

时间窗: at 1 years after surgery

次要结局

  • Range of motion(ROM)(at 1 years after surgery)
  • Adjacent Segment Disease(at 1 years after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu xiaoguang

PH.D.,M.D.,Professor

Peking University Third Hospital

研究点 (1)

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