Short Segment Posterior Fixation With Index Level Screws Versus Long Segment Posterior Fixation for Thoracolumbar Spine Fracture: Angle of Correction and Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- Change in angle of correction
研究概览
简要总结
A prospective study included 91 patients, who had single level thoracolumbar fracture with Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment fixation with screws into the index level, and 47 patients underwent long segment fixation with skipped index level. The angle of correction, pain, and neurological state were regularly assessed
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •wedge fracture or burst fracture with Thoraco-Lumbar Injury Classification and Severity (TLICS) score ≥ 4
- •Single level fracture
- •Less than 50% of spinal canal compromised
- •Mild kyphosis or scoliosis
- •Cobb's angle ≤ 25˚
- •with or without neurological deficit
排除标准
- •patients with multiple level fractures
- •patients with more than 50% spinal canal compromise
- •patients who needed anterior approach to decompress the canal
- •patients who have fracture dislocation and / or marked kyphosis and scoliosis with Cobb's angle >25⁰
- •patients who needed 360⁰ fixation with long segment fixation to maintain the angle of correction.
研究组 & 干预措施
Short Segment posterior spine fixation
Short segment transpedicular screw fixation with inclusion of the index level
干预措施: short segment posterior spine fixation (Procedure)
Long Segment posterior spine fixation
Long segment transpedicular screw fixation with escape of the index level
干预措施: long segment posterior spine fixation (Procedure)
结局指标
主要结局
Change in angle of correction
时间窗: 3rd, 6th, 9th, 12th months
Measurement of Cobb's angle
Change in pain
时间窗: 3rd, 6th, 9th, 12th months
Visual analogue scale assessment
Change in disability
时间窗: 3rd, 6th, 9th, 12th months
assessment of Oswestry Disability Scale
次要结局
未报告次要终点
研究者
Mohamed Nada
Fellow of functional neurosurgery division
Ain Shams University