Comparison of Open vs Minimally Invasive Dorsal Approaches for Foraminotomy and Laminoplasty in the Cervical Spine Through Performance of Head-neck-coordination Analysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Performance of head-neck-coordination after surgery of the dorsal cervical spine
研究概览
简要总结
To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an apparatus to examine head-neck-coordination was constructed.
Two different surgical techniques will be compared:
Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well as 3 and 12 month follow-up.
Hypothesis is that patients after MIS-approaches perform better in their head-neck-coordination as patients with open approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •radicular or myelopathic compression syndrome in the cervical spine
排除标准
- •neurological diseases with influence on the neuromuscular function
- •previous surgery on the cervical spine
结局指标
主要结局
Performance of head-neck-coordination after surgery of the dorsal cervical spine
时间窗: one year
The primary outcomes of this study are the motor control performance measures assessed using force and position controlled tasks. In addition to motor control performance, secondary outcome measures of patient-oriented outcome measures (e.g. pain, disability, etc.) will be collected. Performance measures will consist of the following tasks: * Head-Neck Position Tracking - Rotation and Flexion/Extension * Head-Neck Force Tracking - Flexion, Extension and Lateral Bending Left/Right During the tracking task, a time-varying target (input signal) will be displayed. The participant will be asked to track the specified target by controlling his/her head-neck angle (position tracking) or moment (force tracking). The head position or force during these trials will represent the output signal for the motor control system. These signals will be collected and analyzed in the time and frequency domain to assess error in head-neck motor control.
次要结局
未报告次要终点
研究者
Ralph Kothe, PD Dr. med.
Head of Spine Surgery
Schoen Klinik Hamburg Eilbek
