Percutaneous Vertebroplasty Using Rotary Cutter for Treating Bone Metastases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Back pain: Visual analogue scales system
研究概览
简要总结
Percutaneous vertebroplasty has been applied widely to treat bone metastases. The injected cement may strengthen the affected bone to prevent pathological fractures and relieve the pain. Moreover, the thermal reaction (70°C) due to polymerisation of cement also contributes to tumour destruction. The cement dose and diffusion pattern may be significant factors for the treatment efficacy, which can be affected by the inner pressure of the metastases. The investigators will apply a rotary cutter to destroy the structure of metastases to alleviate the pressure in the metastases. Then, more cement will be injected, which may effectively interdigitates with the surrounding bone and generate more thermo to kill the tumor cells.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Imaging-proven and pathology-proven metastases
- •Intractable pain with neurologic dysfunction
排除标准
- •1. Poor general condition without tolerance of surgery
结局指标
主要结局
Back pain: Visual analogue scales system
时间窗: 3 months
Measuring and comparing the pre- and post-operative back pain via Visual analogue scales (VAS) system with values from 0 to 10 (0 indicating no pain and 10 indicating the worst pain). Patients with a VAS score lower than 3 were classified as the effective group.
次要结局
- Cement volume(during the procedure of vertebroplasty)
- The patterns of cement opacification(during the procedure of vertebroplasty)
- Cement leakage(during the procedure of vertebroplasty)
研究者
Li Min
Vice Director
Jinan Military General Hospital