Comparison of Kyphoplasty With and Without Rotary Cutter Subacute Osteoporotic Vertebral Fractures
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
Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. As the diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones, refractures are often found in patients with conventional PKP. Furthermore, the loss of restored height of surgical vertebrae due to refracture in PKP. The investigators will applied a rotary cutter to destroy the structure of the cavity created by the balloon. Finally, the cement is injected, which may effectively interdigitates with the surrounding cancellous bone.
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 (Care Provider, Investigator, Outcomes Assessor)
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
- •Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure
- •Patient has read and sign the informed consent
- •Male or female, 50 years or older
- •Compressive and burst vertebral body fractures without any neurological deficit.
- •Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment
排除标准
- •Neurological signs related to the vertebral fracture to treat
- •Unmanageable bleeding disorder
- •History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
- •Known allergy to bone cement
- •Local or generalized infection
- •Improvement of the symptoms of the patient with conservative management
结局指标
主要结局
Back pain: Visual analogue scales system
时间窗: up to 2 years
Measuring and comparing the post-operative back pain via Visual analogue scales system
次要结局
- Medico-economic follow-up(up to 2 years)
- Refracture(up to 2 years)
- Kyphotic angle and global thoracic and lumbar angulations(up to 2 years)
- The patterns of cement opacification(during the procedure of PKP)
- Height of the treated vertebral body(Preoperative, up to 2 years)
研究者
Li Min
Vice Director
Jinan Military General Hospital