NCT02075554已完成不适用
Efficacy and Safety of Expandable Spacer in the Treatment of Degenerative Disc Disease Using the Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgical Approach
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- Fusion Assessment
研究概览
简要总结
The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from patients in this 2 year follow-up clinical study.
详细描述
Patients will be followed-up at 3weeks, 6 weeks, 3 months, 6 months, 12 and 24 months with X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work status
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DDD at 1 or 2 levels between L2 and S1
- •Between 18 and 80 years of age
- •Unresponsiveness to documented non-surgical treatment modalities for a minimum of six months
- •Ability to provide a signed Informed Consent
排除标准
- •Trauma at level(s) to be fused
- •Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
- •Immunosuppressive disorder
- •History of substance abuse
- •Any known allergy to a metal alloy
结局指标
主要结局
Fusion Assessment
时间窗: 24 months
An assessment of the fusion status of surgically treated spinal levels.
Fusion and Disc Height Maintenance
时间窗: 24 months
Inter-vertebral disc height in millimetres at 24 month follow up.
次要结局
- Patient Self Assessment(Upto 24 mo)
- Visual Analog Scale for Back Pain(24 months)
研究者
研究点 (4)
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