Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor Securing Methods: A Randomized Single Blind Clinical Trial for Better Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Migration of leads with different methods of securing leads during spinal cord stimulation trial period.
研究概览
简要总结
To assess lead migration rates using different methods of securing leads during Spinal Cord Stimulation trial period.
Spinal cord stimulation has two phases. Trial, which is a precursor for a permanent implantation. Trial lasts less than a week, which gives the patient an opportunity to assess the effectiveness of the treatment.
详细描述
Lead migration has been a known issue/complication with spinal cord stimulation. Lead migration during the trial period can alter the success of a trial. There is no one way of securing the leads to the skin.
Our endeavor was to look at different modes of securing the leads to the skin during the trial period and present their respective lead migration rates. The three methods are
- suturing the leads using 2.0 mono-filament nylon to the skin,
- suture (2.0 mono-filament nylon)over the lead anchor(St.Jude Med Co. long, model # 1106) attaching them to the skin,
- non- suture.
In all three groups copious amounts of benzoin and steri-strips will be used.
Fluoroscopy pictures were taken after the leads were inserted and the level of the leads will be marked. After the trial period, before the leads were removed, an AP/lateral plain X-ray was taken and compared to the fluoroscopy pictures taken at the time of lead placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients undergoing Spinal Cord Stimulation (age > 18yrs)
排除标准
- •patients whose trial period lasts less than 3 days or more than 5 days will be excluded from the study.
- •patients that may require revision of leads or any complication that requires to take the leads out before the end of trial period.
结局指标
主要结局
Migration of leads with different methods of securing leads during spinal cord stimulation trial period.
时间窗: 3-5 days
次要结局
未报告次要终点