NCT02030899已完成不适用
The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Fusion rate
研究概览
简要总结
The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.
详细描述
cage: MC+® cage plate: atlantis® plate
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single level degenerative cervical spine disease
- •aged 30 - 70
- •no improvement of symptom for 8 weeks of non-surgical treatment.
- •degeneration in other levels without stenosis, accepted
排除标准
- •osteoporosis
- •disease with poor bone quality
- •Previous cervical spine surgery
- •Multiple levels disease
- •Ossification of posterior longitudinal ligament
- •Kyphosis at the index level
- •Developmental stenosis (diameter of C7 spinal canal < 10mm)
结局指标
主要结局
Fusion rate
时间窗: 2 years
The rate of interbody fusion at 2 years
次要结局
- cervical lordosis(2 years)
- Segmental angle(2 years)
- pain change(2 years)
- functional status change.(2 years)
研究者
Chun Kee Chung
Professor
Seoul National University Hospital
研究点 (2)
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