Clinical Trial of the Efficacy of Hybrid Systems(Topping Off)in Comparison to the Conventional Spondylodesis in Fusion-surgery in the Lumbal Spine: a Prospective, Randomised Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SF36
研究概览
简要总结
Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?
详细描述
Primary efficacy endpoint:
The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).
Key secondary endpoint(s):
- Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36
- Individual dimensions of the Oswestry Disability Index (ODI)
- Time until radiological adjacent instability and comparison to the clinical outcome
- Capacity of work at the time of surgery and after surgery, time until return to work
Assessment of safety:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >30 years of age
- •Lumbar spine pathology with indication for monosegmental PLIF
- •Radiological signs of a degeneration of the adjacent segment without instability
排除标准
- •Radiological signs of existing instability of the adjacent segment
- •Normal endplates and no disc desiccation in MRI in the adjacent seg-ment
- •Previous surgery of the lumbar spine
研究组 & 干预措施
Arm1: "topping off" system
The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).
干预措施: Topping off system (Device)
Arm 2: monosegmental PLIF
The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
干预措施: monosegmental PLIF (Device)
结局指标
主要结局
SF36
时间窗: 6 Month
Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).
次要结局
- 1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36(6 weeks)
- Safety(all time)
- Individual dimensions of the Oswestry Disability Index (ODI)(6weeks)
- Time until radiological adjacent instability and comparison to the clinical outcome(6 weeks)
- Capacity of work at the time of surgery and after surgery, time until return to work(6 weeks)