A Prospective Single Centre Open Label Trial to Assess the Effectiveness of the Use of Spinal Cord Stimulation in Subjects With Chronic Knee Pain "Failed Knee Surgery"
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Pain Visual Analog Scale
研究概览
简要总结
A study for patients who have chronic postoperative pain who had knee replacement surgery. If qualified, a 14 day trial and an implantation of spinal cord stimulator for control of pain will be administered. This study will evaluate effectiveness of pain control. Subjects will be followed for one year post implantation.
详细描述
Male and Female over the age of 18 who have had a total knee replacement at least nine months ago. Continue with unilateral knee pain equal to or greater than 4 on a 1 to 10 scale. Subjects will receive a trial placement of spinal cord stimulator for 5 to 10 days. if trial is successful subjects will proceed to permanent placement of stimulator for the treatment of the knee pain. subjects will then be followed post implant to assess the effectiveness of the stimulator for the pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years old
- •total knee replacement at least nine months prior to enrollment
- •unilateral knee pain at least 4 or more on a 1-10 visual analog scale
- •failed other conservative treatments -
排除标准
- •life expectancy of at least 6 months
- •significant disease including Complex Regional Pain Syndrome,ipsilateral radiculopathy
- •presence of pacemaker/vns or other Spinal Cord Stimulator
- •previous lumbar surgery
- •active infection
- •unable to hold anticoagulants
结局指标
主要结局
Pain Visual Analog Scale
时间窗: one year
standardized visual pain scale
次要结局
- Health Related Quality of Life(one year)