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临床试验/NCT00737607
NCT00737607Unknown不适用

Clinical Study of Microendoscopic Decompressive Laminotomy for Treatment of Lumbar Spinal Stenosis

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1

研究概览

简要总结

The study is a prospective outcome study to evaluate the effectiveness and treatment outcomes of microendoscopic decompressive laminotomy (MEDL) with objective evaluation tools. The patients who fulfill the selection criteria will be enrolled to collect the pre-operative clinical data including demographic data, image studies, and functional evaluation for neurological symptoms and disability.

The patient will receive MEDL and post-operative follow-up will be arranged at 1 week, 1 month, 6 months, and 12 months after the operation. All the collected data will be analyzed to evaluate the efficacy and treatment results of MEDL.

详细描述

The patients undergoing microendoscopic decompressive laminotomy (MEDL) for lumbar spinal stenosis (LSS) between will be enrolled in this prospective study. The patients included must fulfill the following selection criteria:

  • neurogenic claudication or radicular leg pain with associated neurologic signs referring to the LSS syndrome;
  • moderate to severe spinal canal stenosis shown on cross-sectional imaging such as MRI or CT scan;
  • failure of conservative treatment for at least three months.

The patients who presents with either mechanical low back pain or segmental instability. Mechanical lower back pain is defined as pain that was induced by posture change, or that prevents the patient from sitting or standing for more than 30 minutes. Patients are considered to have segmental instability if they had isthmic spondylolisthesis, degenerative spondylolisthesis with more than 4 mm of translation or intervertebral angle reversal on dynamic radiographs.18 Surgical techniques

All the surgical procedures will be performed by a single surgeon (J. P.). The patients is positioned prone on the Relton-Hall frame after general anesthesia. Decompression is done under the endoscope with the tubular retraction system METRx (Medtronics, Minneapolis, MN). For patients with unilateral neurological symptoms, we will perform unilateral laminotomy and foraminotomy. For patients with bilateral neurological symptoms, we will performe unilateral laminotomy for bilateral decompression (ULBD) to decompress the central canal and bilateral lateral recesses.

When performing multiple-level decompression, the skin incision will be centered at the midpoint between selected intervertebral disc levels. The incision can be mobilized one level above or below after releasing the underlying connective tissues. Then we can set up the tubular retractor system through separate muscular portals for each level. For patients with small stature, we can perform a three-level surgery through a single surgical wound, just as the same size as we perform the single-level surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • neurogenic claudication or radicular leg pain with associated neurologic signs referring to the LSS syndrome
  • moderate to severe spinal canal stenosis shown on cross-sectional imaging such as MRI or CT scan
  • failure of conservative treatment for at least three months

排除标准

  • mechanical low back pain or segmental instability

研究者

申办方类型
Other

研究点 (1)

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