跳至主要内容
临床试验/NCT01988259
NCT01988259Unknown不适用

Comparison of Open vs Minimally Invasive Dorsal Approaches for Foraminotomy and Laminoplasty in the Cervical Spine Through Performance of Head-neck-coordination Analysis

Schoen Klinik Hamburg Eilbek2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年9月1日最近更新:
适应症

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

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

发起方
Schoen Klinik Hamburg Eilbek
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ralph Kothe, PD Dr. med.

Head of Spine Surgery

Schoen Klinik Hamburg Eilbek

研究点 (2)

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