NCT01557829已完成不适用
Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion
Amedica Corporation3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Roland Morris Disability Questionnaire (RMDQ)
研究概览
简要总结
This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age 18-75 years
- •Chronic low back pain unresponsive to at least six months of conservative care
- •MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II
排除标准
- •Osteoporosis
- •Patients with prior failed fusion at the same level
- •Degenerative scoliosis
- •Degenerative spondylolisthesis greater than Grade II
- •Pregnancy
- •Psychiatric or mental disease
- •Alcoholism (drinking more than 5 units per day)
- •Active infection or prior infection at the surgical site
- •Active cancer
- •Insufficient language skills to complete questionnaires
- •Participation in another study
- •More than two symptomatic levels that need fusion
结局指标
主要结局
Roland Morris Disability Questionnaire (RMDQ)
时间窗: 12 months post-op
The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared
次要结局
- Fusion status(3 mo., 6 mo., 12 mo., 24 months)
- Oswestry Disability Index (ODI)(12 months post-op)
研究者
研究点 (3)
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