Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors
试验速览
- 阶段
- 不适用
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- pain relief
研究概览
简要总结
Percutaneous vertebroplasty is a new technique to strengthen bone and reduce pain for patients with vertebral tumors
详细描述
Destructive vertebral lesions are a common in metastatic disease, multiple myeloma and lymphoma. Symptoms are caused by pathologic fracture consequences secondary to vertebral destruction, development of spinal instability and compression of adjacent neurological elements. Nonoperative treatments include radiotherapy, hormone therapy, cytotoxic drugs which are effective to halt the osteolytic process and reverse the neurological compromise, however; they cannot provide stability or relieve pain or cord compression. Surgical management options including vertebrectomy, reconstruction with a cage or PMMA bone cement, and stabilization with pedicle screws can restore spinal canal support and neurological functions also control pain, however; usually associated with high postoperative morbidity and mortality. Also not advisable for multifocal spinal disease. Percutaneous vertebroplasty is a new technique to strengthen bone and reduce pain. It is percutaneous, minimally invasive, image-guided procedure that involves injection of radio-opaque bone cement into a partially collapsed vertebral body, in an effort to provide stability and pain relief. The exact mechanism of pain relief remains unclear. Proposed theories include more favourable biomechanics after cement strengthening, chemical toxicity and exothermic effect of cement polymerization on nerve endings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 100 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal instability
- •Pain with movement
- •Multiple level involvement
- •Expected survival 3-6 months
排除标准
- •Asymptomatic
- •improving on medical treatment without worsening of the collapse.
- •infection local or systemic
- •uncorrectable coagulopathy
- •Allergy to bone cement or contrast media
- •Radicular pain
- •Tumor extension inside the vertebral canal or cord compression
- •Fracture of the posterior column
- •Sclerotic metastasis
- •Diffuse metastases
研究组 & 干预措施
percutaneous Vertebroplasty
patients meet the inclusion and exclusion criteria will be subjected to percutaneous vertebroplasty receiving bone cement (Polymethyl methacrylate)
干预措施: Bone Cements (Drug)
结局指标
主要结局
pain relief
时间窗: immediate
reduction of spine pain following the injection of bone cement in the tumor according to Numeric Rating Scale, Improvement will be considered if NRS score decrease ≧ 20% after PVP
次要结局
未报告次要终点
研究者
Mustafa syd
Principal Investigator
Assiut University
