NCT01588054已完成不适用
Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Radiographs
研究概览
简要总结
The purpose of this study is to define clinical and demographic features within the population suffering from cervical deformity to assist health professionals to make important treatment decisions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 years of age or greater
- •Cervical deformity (kyphosis C2-7 greater than 10 degrees or scoliosis with coronal cobb greater than 10 degrees)
- •Plans for surgical correction of cervical deformity
排除标准
- •Active tumor or infection
- •Acute trauma
- •Unwillingness to provide consent or complete study forms
- •Pregnant or planning to get pregnant during study period
结局指标
主要结局
Radiographs
时间窗: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Changes in the degree of deformity post surgical correction and assessment of fusion.
次要结局
- Neck Disability Index (NDI)(Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop)
- CSRS SWAL-QOL(Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop)
- Numeric rating scale (NRS)(Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop)
- mJOA(Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop)
- EQ-5D3L(Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop)
研究者
研究点 (10)
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