TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Roland Morris Disability Questionnaire
研究概览
简要总结
Braces have been used o treat stable (not requiring surgery) burst fractures with much success. Recently questions have been raised in regards to the importance of the brace. Some studies have results that suggest a brace is not important in having a good outcome. However, this has never been proven. This study is being conducted to see whether or not wearing a brace is important to having a good outcome.
详细描述
The purpose of this study is to prospectively compare the outcome between patients randomly assigned to a thoracolumbosacral orthosis (TLSO) treatment group or no orthosis (NO) treatment group, for the management of an acute AO type A3 thoracolumbar fracture.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AO A3 burst fracture between T10 and L3 with associated kyphotic deformity <35 degrees
- •neurologically intact or isolated nerve root deficit
- •age 16-60 years
- •enrollment within 3 days of injury
排除标准
- •neurological deficit
- •can not comply with brace wearing (pregnancy/body mass index >40)
- •mobilized with or without a brace prior to recruitment
- •suffered a pathologic or open fracture
- •alcohol or drug abusers
- •had previous injury or surgery to the thoracolumbar region
- •unable to complete the questionnaires
结局指标
主要结局
Roland Morris Disability Questionnaire
时间窗: 3 months post fracture
The primary outcome measure is the Roland Morris Disability Questionnaire (RMDQ) administered at 3 months post fracture. The RMDQ evaluates physical disability secondary to low back pain and is validated, simple to administer, sensitive, and reliable. The questionnaire evaluates 24 items to derive a score that varies between zero (no disability) and twenty-four (severe disability). Three months was chosen because it is the time point at which we expect a significant functional recovery and readiness to resume most normal activities.
次要结局
- SF-36 physical component summary score(enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years)
- SF-36 mental component summary score(enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- VAS pain score(enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months)
- Satisfaction with Treatment(enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months)