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临床试验/NCT00876603
NCT00876603Unknown不适用

A Comparison of Anterior and Posterior Procedures for the Surgical Management of Cervical Spondylotic Myelopathy: Prospective Randomized Clinical Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2001年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Japanese Orthopaedic Association Score for Cervical Myelopathy

研究概览

简要总结

There is no difference in surgical outcomes for patients suffering from cervical spondylotic myelopathy treated with anterior decompression and fusion or posterior cervical laminoplasty.

详细描述

Cervical spondylotic myelopathy (CSM) is a syndrome consisting of symptoms and signs of cervical spinal cord compression caused by chronic degenerative changes of the cervical spine. CSM is the most serious and disabling condition of cervical spondylosis. Natural history studies showed that most of the CSM patients have a progressive deterioration course and no spontaneous regression occurs. It is suggested that the patients with moderate to severe CSM should be operated as early as possible before neurological deficits are too pronounced.

Although there are many options available for the surgical treatment of cervical spondylotic myelopathy, the choice of surgical approach for CSM is still a controversial issue. Most of the surgeons select the surgical approach based on the number of levels involved and the alignment of the spine. Anterior procedure is generally recommended for patients with compression of less than 3 levels or in patients with kyphotic alignment, while posterior decompression is suggested for three or more levels of compression. Retrospective clinical study however has shown that both anterior and posterior surgeries could produce comparable results. There is no scientific data based on randomized, prospective clinical studies comparing the various surgical alternatives. The existing information does not clearly favor any one single approach or operative option. Since anterior and posterior surgeries carries different risks, it is important to identify the most appropriate surgical procedure that is supported by evidence rather than just by surgeons preference.

The objective of this study is to compare the long-term clinical outcome of anterior approach versus posterior approach in the treatment of cervical myelopathy caused by degenerative disease of the cervical spine.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with transverse lesion type of cervical myelopathy caused by cervical spondylosis requiring surgery.
  • Involved levels limited to 1, 2 and 3 continuous levels

排除标准

  • Radiculomyelopathy
  • Cervical kyphosis
  • Cervical myelopathy caused by high energy trauma
  • Female > 70 years old or patients with severe osteoporosis
  • High anaesthetic risk
  • Cervical myelopathy other than transverse type
  • Cervical myelopathy caused by ossification of posterior longitudinal ligament or inter-vertebral disc herniation.

结局指标

主要结局

Japanese Orthopaedic Association Score for Cervical Myelopathy

时间窗: 3 months, 6 months, 1 year, 3 years, 5 years and 10 years

次要结局

  • Motor and sensory functions, gait and hand functions, neck pain, change in cervical alignment, spinal cord signal change on MRI, operative time, blood loss, duration of in-patient stay, post-operative complication, re-operation rate.(3 months, 6 months, 1 year, 3 years, 5 years and 10 years)

研究者

申办方类型
Other

研究点 (1)

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