Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures: a Multiple Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- change of pain relief
研究概览
简要总结
Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. Because of the procedure , neither patients nor investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.
详细描述
This study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. Patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. Patients will be randomised into 2 arms with average amount. The participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods.
Patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. The primary outcome will be the pain release , categorised according to WHO classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •vertebral compression fracture on spine radiograph (minimum 15% height loss)
- •level of fracture at Th5 or lower; back pain for 6 weeks or less
- •focal tenderness at fracture level on physical examination
- •bone oedema of vertebral fracture on MRI
- •decreased bone density (T scores ≤-1)
排除标准
- •severe cardiopulmonary comorbidity
- •suspected underlying malignant disease
- •radicular syndrome
- •spinal-cord compression syndrome
- •contraindication for radiography exam
研究组 & 干预措施
grade 1
percutaneous vertebroplasty
干预措施: percutaneous vertebroplasty (Procedure)
grade 2
conservative treatment
干预措施: conservative treatment (Procedure)
结局指标
主要结局
change of pain relief
时间窗: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
World Health Organization pain classification
次要结局
- quality of life(1 day, 1 week, 1 month, 3 months, 6 months, and 1 year)
研究者
Liu Haiying
Director department of spinal surgery
Peking University People's Hospital