NCT02085811Unknown不适用
Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Measure of Spinal kyphosis angle
研究概览
简要总结
The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures.
Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU.
An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination.
The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Men or women aged at least 18;
- •who underwent Kyphoplasty between T11 and L5,
- •Patients who had Kyphoplasty at a single level without associated surgery,
- •Magerl type-A fracture.
- •Non-tumoral and non-osteoporotic cause.
排除标准
- •Compression fracture outside the T11-L5 segment, or fracture other than Magerl type A.
- •Osteoporotic vertebral fracture
- •Association with other post-traumatic fractures.
- •History of Balloon Kyphoplasty, or of thoracic or lumbar spine surgery except simple discectomy.
- •Pregnant or breast-feeding women
- •Patients not covered by national health insurance
结局指标
主要结局
Measure of Spinal kyphosis angle
时间窗: Between the post-operative period (D1) and a minimum of one year of follow-up
次要结局
- Evaluation of pain (VAS)(At least 1 year after the kyphoplasty)
- Number of new vertebral fractures(At least 1 year after the kyphoplasty)
- Evaluation of quality of life (OSWESTRY and EIFEL)(At least 1 year after the kyphoplasty)
- Evolution of the regional angle of vertebral kyphosis(At least 1 year after the kyphoplasty)
研究者
研究点 (1)
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