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临床试验/NCT03427632
NCT03427632Unknown不适用

Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors

Assiut University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年3月1日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa syd

Principal Investigator

Assiut University

研究点 (1)

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