Randomized Trial of Early Versus Delayed Surgery for Acute Traumatic Cervical Spinal Cord Injury Without Bone Injury in Patients With Cervical Canal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- ASIA motor score
研究概览
简要总结
Controversy exists regarding the optimal management of acute traumatic cervical spinal cord injury (SCI), especially those without bone injury. Although surgical decompression is often performed in SCI patients with cervical canal stenosis, efficacy and timing of surgery continues to be a subject of intense debate. In this randomized controlled trial, the investigators compare two strategies: early surgery within 24 hours after admission and delayed surgery following at least 2 weeks of conservative treatment. The purpose of this study is to examine whether early surgery would result in greater improvement in motor function as compared with delayed surgery.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute traumatic cervical spinal cord injury (at C5 or below) admitted within 48 hours after injury
- •No bone injury (no fracture or instability)
- •American Spinal Injury Association (ASIA) Impairment Grade C
- •Cervical canal stenosis due to preexisting conditions such as spondylosis and ossification of the posterior longitudinal ligament (OPLL)
排除标准
- •Unstable medical status
- •Difficult to undergo surgery within 24 hours after admission
- •Impaired consciousness or mental disorder that precludes neurological examination
- •Difficult to obtain informed consent in Japanese
结局指标
主要结局
ASIA motor score
时间窗: baseline and one year
change from baseline to one year in the American Spinal Injury Association (ASIA) motor score
Spinal Cord Independence Measure (SCIM)
时间窗: one year
the total score of the Spinal Cord Independence Measure (SCIM) version 3
the ability to walk without assistance
时间窗: one year
proportion of patients who regained the ability to walk without assistance
次要结局
- Health-related quality of life(one year)
- Neuropathic pain(one year)
- Walking status(one year)
研究者
Hirotaka Chikuda
Lecturer
Tokyo University