NCT02016794已完成不适用
A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration
AO Clinical Investigation and Publishing Documentation2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2014年2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
- 9
- 试验地点
- 2
- 主要终点
- Effect of neck pain on everyday life measured by the Neck Disability Index (NDI).
研究概览
简要总结
Degenerative cervical spine conditions lead to chronic neck and arm pain. Surgical treatment may require anterior decompression and fusion, which usually is established with a cage implant. The Anterior Cervical Interbody Spacer (ACIS) is such a cage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or older
- •Degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels
- •Degenerative cervical disc disease C3 through Th1 or
- •Ruptured and herniated discs C3 through Th1
- •Ability to understand the content of the patient information / informed consent form
- •Willingness and ability to participate in the registry according to the registry plan (RP)
- •Signed and dated IRB / EC-approved written informed consent
排除标准
- •Spinal tumor
- •Osteoporosis
- •Cervical trauma and instability
- •Any not medically managed severe systemic disease (ie. infection)
- •Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- •Pregnancy or women planning to conceive within the registry period
- •Participation in any other medical device or medicinal product clinical investigation or registry within the previous month that could influence the results of the present registry
- •Intraoperative exclusion criteria:
- •Intraoperative decision to use implants other than the device under investigation
结局指标
主要结局
Effect of neck pain on everyday life measured by the Neck Disability Index (NDI).
时间窗: 6 months
次要结局
- Length of Hospital Stay(Expected average of 5 days)
- Pain(Baseline; 1-2days; 6 weeks; 6 months)
- Adverse Events(Intra and post operative)
- Handling details(Intraoperative)
研究者
研究点 (2)
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