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临床试验/NCT01367405
NCT01367405终止不适用

COSMIC: Conservative or Early Surgical Management of Incomplete Cervical Cord Syndrome Without Spinal Instability. Randomized Controlled Trial

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
Dutch translation of mJOA

研究概览

简要总结

Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical entity. The most characteristic feature is the disproportionate more motor impairment of the arms and especially the hands than the legs, bladder dysfunction and sensory.

Recently, it has been shown that the distinction of TCCS with an incomplete cervical spinal cord lesion (ICSCL) is artificial. It is the most frequent incomplete traumatic spinal cord lesion. It accounts for up to 70 % of all incomplete cervical spinal cord lesions. The exact incidence is not known.

Uncertainty about the treatment exists. A good recovery has been described after conservative treatment. Conservative treatment was usually considered when a fracture or dislocation of the spine were absent. It is often seen in hyperextension trauma in the elderly with degenerative spondylotic stenotic cervical spine. However, some reports suggest a better outcome after surgical decompression. Randomized trials have not been performed. To avoid discussion about possible confounding or effect modification related to the mechanism of trauma, this study will focus on ICSCL in patients without fracture or instability of the cervical spine on radiological examination. Also the problem of crossover from the conservative group to the surgical one due to the nature of spinal instability will be reduced.

Goal of the study: To compare the efficacy of early decompressive surgery to improve functional outcome in patients with ICSCL without a fracture or instability of the cervical spine compared to those receiving conservative treatment.

Definition of ICSCL in this study: ICSCL is an incomplete spinal cord lesion due to a cervical spine trauma. At CT scanning with reconstruction and at MRI signs are not seen that could indicate a fracture of the cervical spine or instability. An overt sequestrated herniated disc should not be present since this will always necessitate immediate surgery. Involvement of the cervical spinal cord should be established at physical examination (symptomatic arm or hand dysfunction is obligatory).

详细描述

See Above. Further information in this registration ( Randomized controlled trial (RCT), sample size etc)

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
None

入排标准

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

入选标准

  • all patients with a history of a traumatic event to the cervical spine fulfilling the criteria of incomplete cervical spinal cord lesion. -

排除标准

  • cognitive impairments
  • a preexistent neurologic deficit of arms and/or legs
  • psychiatric illness
  • significant comorbidity interfering with the indication to perform surgery or not
  • use of anticoagulating drugs
  • addiction to drugs or alcohol (more than five units daily)
  • not speaking Dutch language fluently
  • not willing to participate
  • participating in another trial

结局指标

主要结局

Dutch translation of mJOA

时间窗: two years post-injury

functional outcome at two years measured by Dutch translation of mJOA

次要结局

  • DASH(two years post-injury)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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