Postrual Reduction With Pillow in Osteoporotic Vertebral Fractures: a Randomized, Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Sagittal plane contour
研究概览
简要总结
Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Patients eligible for the study were selected by an independent research assistant. The study was explained, and informed consent was obtained from patients before the surgery. Using a randomization sequence, the patients were assigned to the international or control group. The attending surgeons and patients were blinded before the surgery.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single level osteoporotic compression fracture of thoracic and lumbar spine
排除标准
- •Can't tolerate the postural reduction by pillow
- •Pathological spine fracture caused by tumor, infection.
- •Multiple spine fractures
- •Patient presented with neurological. deficits
研究组 & 干预措施
Pillow group
Before surgery, with the patient lying in the supine position, a soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position. 12 hours duration suggested from 11:00 pm 1 night before the surgery till next day.
干预措施: Pillow (Other)
No pillow group
No intervention was given in this group before surgery.
结局指标
主要结局
Sagittal plane contour
时间窗: 6 months of post-operative follow up
Sagittal plane measurement by measuring the Cobb angle of the injured vertebral on lateral radio-graphs
次要结局
- Functional outcome(6 months of post-operative follow up)
研究者
vghtpe user
Department of orthopedics
Taipei Veterans General Hospital, Taiwan