Epidural Decompression Surgery Within 24 Hours After Acute Spinal Cord Injury Improves Spinal Nerve Function: a Prospective, Multicenter, Non-randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- American Spinal Injury Association (ASIA) motor and sensory scores
研究概览
简要总结
To compare the effects of early (within 24 hours) and delayed (exceed 24 hours) epidural decompression surgery on the recovery of spinal nerve function in patients with acute spinal cord injury (complete and incomplete) at postoperative 6 months.
详细描述
Whether early epidural decompression surgery can restore neurological function in patients with acute spinal cord injury (complete and incomplete), and an effective time window for epidural decompression, are still controversial.
This trial will verify whether early epidural decompression surgery is more conducive to the recovery of spinal nerve function in patients with acute spinal cord injury (complete and incomplete) compared with delayed surgery. This trial will begin in August 2017. Data analysis of 200 patients will be finished in December 2019. All results will be completed in December 2020. This trial will provide clinical evidences for the selection of timing of epidural decompression surgery in patients with complete and incomplete spinal cord injury.
Adverse events Adverse events will be obtained from patients or their legal representatives. Major adverse events will include: limb paralysis deterioration, re-operation, respirator use (more than 1 week), tracheostomy, septicemia, pneumonia, acute respiratory distress syndrome, atelectasis, other respiratory complications, wound infection (superficial and deep), urinary tract infection, other infections, gastrointestinal bleeding, peptic ulcer, intestinal obstruction, acute myocardial infarction, other heart events, pulmonary embolism, cerebrovascular complication, hepatic failure, renal failure, delirium and depression.
Statistical methods
- All data will be analyzed using SPSS 19.0 software.
- Normally distributed measurement data will be expressed as mean, SD, minimums, and maximums. Non-normally distributed measurement data will be expressed as the lower quartile (q1) and median and upper quartiles (q3). Count data will be presented as the percentage.
- Measurement data among groups will be compared using two-sample t-test or Mann-Whitney U test.
- Count data will be analyzed using chi square test or Fisher's exact test. Ranked data will be analyzed using Wilcoxon signed-rank test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury patients will be evaluated as complete or incomplete (contusion) after admission using rectal examination, in accordance with American Spinal Injury Association and International Medical Society of Paraplegia (2000);
- •Final diagnosis by spine CT and/or MRI;
- •Cervical, thoracic and thoracolumbar fracture dislocation or without fracture dislocation but combined with spinal cord injury;
- •No other injury involving life, injury severity score < 16;
- •No anesthesia contraindication;
- •No local skin infection, no severe soft tissue contusion, soft tissue condition of the operation area met the operation requirements;
- •Age: 16-85 years old, irrespective of sex.
排除标准
- •Active or recent severe infection
- •Severe infectious diseases that need to be treated in infectious disease hospital;
- •History of mental illness;
- •History of metal allergy;
- •Long-term alcohol abuse and drug abuse;
- •Do not agree to participate in this trial; the legal representative of the patient refuses to sign informed consent;
- •Poor compliance, cannot be followed up as required.
结局指标
主要结局
American Spinal Injury Association (ASIA) motor and sensory scores
时间窗: at postoperative 6 months
To assess spinal nerve function. Evaluation criteria for neurological function after spinal cord injury: Neurological function will be evaluated in accordance with American Spinal Injury Association and International Medical Society of Paraplegia (2000).
次要结局
- American Spinal Injury Association (ASIA) impairment scale(changes of week 1, month 1 and month 3 after surgery)
- Evaluation of the incidence of complications(changes of week 1, month 1, month 3 and month 6 after surgery)
研究者
Baoguo Jiang
Principal Investigator
Peking University People's Hospital