Radiostereometric Analysis of Spine Arthrodesis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intervertebral motion post-op lumbar fusion
研究概览
简要总结
The primary objective of this pilot study is to determine the precision of post-operative radiostereometric measurements for the assessment of lumbar spinal fusion. This study will also determine the potential for RSA as a more precise and accurate means for assessment of lumbar spinal fusion and diagnosis of pseudarthrosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic degenerative disc disease of the lumbar spine indication surgical intervention
- •Scheduled to undergo lumbar fusion surgery
- •Patients between the ages of 18 and 75
- •Ability to give informed consent
排除标准
- •Pregnant women
结局指标
主要结局
Intervertebral motion post-op lumbar fusion
时间窗: 2 years
The purpose of this radiostereometric analysis (RSA) evaluation is to measure relative intervertebral motion in lumbar spinal fusions. Two RSA loading provocation protocols will be employed in this study; sitting and supine extension. Both loading protocols will be compard to a standard supine position which is used as an unloaded baseline protocol. Induced intervetebral motion sets will be calculated between the two loaded states, sitting and supine extension, and the unloaded state. The RSA micromotion results will be calculated and reported as translations and rotations about the three anatomic axes, maximum total point motion (MTPM) will be calculated as well.
次要结局
未报告次要终点