The Relationship Between Sagittal Plane Correction and Quality of Life in Adult Deformity Patients Treated With Posterior Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Correlation between correction of SVA and improvement ODI
研究概览
简要总结
The purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a spinal fusion surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Correlation between correction of SVA and improvement ODI
时间窗: preop, 3 months, 6 months, 12 months, 24 months
The primary objective is to evaluate the correlation between: * the correction of the Sagittal Vertical Alignement (SVA), expressed in centimeters - SVA is the distance between C7 plumbline and the posterior of the superior endplate of S1) * the improvement of the Oswestry Disability Index (ODI) is the positive difference of the preoperative score and the postoperative score - expressed in % or a score (/50)
次要结局
- Adjacent levels degeneration(preop, 24 months)
- Fusion(preop, 24 months)
- Complications associated with the device(preop, 3 months, 6 months, 12 months, 24 months)
- Complications associated with the surgery(preop, 3 months, 6 months, 12 months, 24 months)
- Coronal correction(preop, 3 months, 6 months, 12 months, 24 months)
- Correction of the sagittal parameters(preop, 24 months)
- improvement of Quality of life(preop, 3 months, 6 months, 12 months, 24 months)
- Vertebra rotation(preop, 24 months)