NCT00726128已完成不适用
A Multi-Center Prospective Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 4
- 主要终点
- Proportion of Patients with radiographic fusion
研究概览
简要总结
To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System
详细描述
The purpose is to prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient will undergo anterior cervical fusion with the VueLock™ Anterior Cervical Plate System for treatment of degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusion.
- •The patient must be available for follow-up during the study.
- •The patient must be skeletally mature (epiphyses closed).
排除标准
- •Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
- •Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
- •Pregnant or nursing females.
- •Patients who in the opinion of the investigator would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unstable to participate in the follow-up.
结局指标
主要结局
Proportion of Patients with radiographic fusion
时间窗: 24 Months
次要结局
- Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline(24 Month)
研究者
研究点 (4)
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