Efficacy and Safety of Anterior Cervical Spine Surgery in Patients With Cervical Degenerative Disc Disease - a Real World Data Collection and Analysis Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Japanese Orthopaedic Association Scale
研究概览
简要总结
This observational study aims to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease
详细描述
This observational study is an ambispective cohort designed. Patients who are diagnosed cervical degenerative disc disease will be selected to join in this study. Visual Analogue Scale, Japanese Orthopaedic Association Scale, Neck Disability Index, SF-36, and device related or procedure related adverse events will be recorded and compared to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients over 18 years old
- •Clinical symptoms and imaging support cervical degenerative disc disease；
- •Failed a minimum of 3months conservative treatment
- •Have had (retrospective cohort) or the decision has been made to have (prospective cohort) anterior cervical spine surgery
- •Written informed consent given by subject
排除标准
- •Patients with non-degenerative (e.g., trauma, tumor, and infection) or neuromuscular diseases (e.g., motor neuron disease) were excluded
- •Patients with cervical spine X-ray film and CT scan contraindications
- •Women who are lactating and pregnant
结局指标
主要结局
Japanese Orthopaedic Association Scale
时间窗: 1st year
Establishing criteria for mild, moderate and severe impairment in patients with degenerative cervical myelopathy. The minimum value is 0, and the maximum value is 17. Higher scores mean a better outcome.
次要结局
- Neck Disability Index(1st year)