VERTOS II. Percutaneous Vertebroplasty Versus Conservative Therapy in Patients With Osteoporotic Vertebral Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- To compare the cost-effectivity in the two groups
研究概览
简要总结
Percutaneous vertebroplasty is a new procedure for treating painful osteoporotic compression fractures of the spine. Five-thousand out of 12.000 patients (16.000 vertebral fractures/year in the Netherlands) present with sudden, severe back pain in the region of the fracture.Until recently, bed rest, analgesia and physical support were the only treatment options. After decades of performing PV, no large RCT with mid-term follow-up has been published.
Design:
This will be a multicenter (6 centers), prospective, randomised, intervention study. Eligible patients will be randomised for percutaneous vertebroplasty or conservative therapy.
Study population:
Age: 50 and older, vertebral fracture, level: thoracic vertebral body 5 (Th 5) or lower, osteopenia (T-score < -1 SD), back pain for no more than 6 weeks and edema in the vertebrae on MR imaging
Statistical analyses All analyses will be performed on an 'intention to treat' principle. The planned number of subjects will be 200 in total, 100 in each intervention arm.
Economic evaluation:
Cost-effectiveness will be assessed. The costs of the procedure and the medical treatment, and of visits to medical specialists, GP's and physical therapists will be compared.
Time schedule:
The total study will take 36 months
Recruitment of patients (200) has been completed. In May 2009 the 1 year follow-up will be finished.
详细描述
Design:
This will be a multicenter (6 centers), prospective, randomized, intervention study. Eligible patients will be randomized for percutaneous vertebroplasty or analgesics.
Study population:Two hundred patients will be included.
Patient selection:
Patients will be referred from the GP to the radiology department for acute back pain. The GP will order an X-ray of the thoracic and lumbar spine to establish an osteoporotic vertebral fracture(s). Subsequently, the hospital radiologist will pick out the cases with vertebral fracture(s). Subsequently, the general physician/ geriatrician will confirm the diagnosis of 'osteoporotic' vertebral fracture, and exclude other causes of vertebral fracture (e.g. tumour, major trauma). Finally, the patient and their GP will be asked to participate in our study.
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 —（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
To compare the cost-effectivity in the two groups
时间窗: 1 month, 1 year
VAS score in time
时间窗: 1 month, 1 year
次要结局
- To compare pain relief and the quality of life of the patients in the two groups.(1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 24 months)
研究者
Clinical Research Office Imaging Division
Clinical research coordinator
UMC Utrecht