跳至主要内容
临床试验/NCT02284945
NCT02284945已完成不适用

A Randomized Controlled Trial Comparing Open Spinal Stabilisation and Percutaneous Solution (TPS) Surgery in Patients With Metastatic Spinal Disease.

The Leeds Teaching Hospitals NHS Trust0 个研究点开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
主要终点
Oswestry disability score

研究概览

简要总结

Spread of cancer to the spinal column is a growing problem in patients with cancer. It can cause a number of problems including pain, instability and neurologic problems. If left untreated, progressive weakness, numbness and bladder/bowel disturbance occurs. The aim of treatment is to help with pain and to reduce the risk of these neurological problems. This treatment has traditionally been radiotherapy to the spine. Surgery has always meant large open operations with a long recovery time and significant risk of complications. There has been new technology that has allowed less invasive operations to take place to stabilise the spine. The aim is to relieve the pressure on the spinal cord in addition to stabilising the spinal cord. These techniques are called 'minimally invasive' and include surgical techniques such as cement augmentation and percutaneous instrumentation.

The aim of this study is to compare traditional open operations with these new minimally invasive techniques to see if they do result in reduced complications and quicker recovery in addition to achieving the goals of surgery.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Has an age ≥ 18 years
  • Is suitable for radiotherapy
  • Has been assessed by the oncologist
  • Has symptoms of pain
  • Is diagnosed with metastatic spinal pain from MRI findings with or without biopsy
  • Technically possible to perform the surgery
  • Is willing and able to comply with required followup questionnaires
  • Is able to understand the risks and benefits of participating in the study
  • Understands and has signed the informed consent form.
  • Life expectancy of > 3 months

排除标准

  • Active systemic infection or infection localized to the site of implantation
  • Allergy or sensitivity to Polyether ether ketone (PEEK), Titanium or Tantalum
  • A bleeding disorder precluding from invasive surgery
  • Rapid neurological deterioration requiring urgent surgery which would be delayed to the detriment of the patient by including in this study

结局指标

主要结局

Oswestry disability score

时间窗: 2 years

EuroQoL Questioonaire (EQ-5D)

时间窗: 2 years

Visual analogue pain (VAS) scores

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

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