NCT00565734已完成不适用
An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
AO Clinical Investigation and Publishing Documentation1 个研究点 分布在 1 个国家目标入组 479 人开始时间: 2007年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 479
- 试验地点
- 1
- 主要终点
- Surgical complications and neurological, functional, disease-specific and quality of life measures
研究概览
简要总结
The primary purposes of this study are to compare anterior and posterior surgical approach in treatment of CSM ad to compare variations in treatment and outcomes of CSM worldwide.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Willing and able to give written informed consent to participate in the study
- •Willing and able to participate in the study follow-up according to the protocol
- •Willing and able to comply with post-operative management program
- •Understand and read country language at elementary level
- •Patients who undergo surgery for symptomatic CSM defined as a combination of one or more of the following symptoms:
- •Numb hands
- •Clumsy hands
- •Impairment of gait
- •Bilateral arm paresthesiae
- •l'Hermitte's phenomena
- •AND one or more of the following signs:
- •Corticospinal distribution motor deficits
- •Atrophy of hand intrinsic muscles
- •Hyperreflexia
- •Positive Hoffman sign
- •Upgoing plantar responses
- •Lower limb spasticity
- •Broad based, unstable gait
排除标准
- •Asymptomatic CSM
- •Previous surgery for CSM
- •Active infection
- •Neoplastic disease
- •Rheumatoid arthritis
- •Ankylosing spondylitis
- •Concomitant symptomatic lumbar stenosis
- •Pregnant women or women planning to get pregnant during the study period
- •Has a history of substance abuse (recreational drugs, alcohol)
- •Is a prisoner
- •Is currently involved in a study with similar purpose
- •Has a disease process that would preclude accurate evaluation (eg., neuromuscular disease, significant psychiatric disease)
- •Patients seen by other services (eg., physical medicine, neurology, family practice), managed conservatively and not referred for surgical consultation are ineligible.
结局指标
主要结局
Surgical complications and neurological, functional, disease-specific and quality of life measures
时间窗: 24 months
次要结局
- Differences in patient presentation, treatment approaches and treatment outcomes among ethnic/racial groups, health care systems and regions of the world(24 months)
研究者
研究点 (1)
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