Effect of Bracing Versus No Bracing in Stable Thoracolumbar Compression and Burst Fractures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
Spinal orthoses have been used in the treatment of non-operative thoracic and lumbar fractures with much success. However, there has been increasing questioning as to wether or not the orthotics are necessary to have a good overall outcome. Being fitted for and acquiring braces are associated with great expense and increased hospital stays. The purpose of this study is to determine wether or not braces are required for good outcome post thoracic or lumbar fracture.
详细描述
Several tens of patient's per year come to the Emergency Department with thoracolumbar spine compression and burst fractures that are not indicated for surgical fixation. Currently, these patients are treated non-operatively through brace wear which is either custom made for the patient or is off-the-shelf pending location of the fracture and surgeon preference. All braces are through the currently contracted orthotics company. As they are non stocked in house, waiting for the brace requires the patients to remain on "strict spine precautions" (flat bed rest in a Miami J collar, no pillows behind the head, and logrolls for turning) for anywhere from 24-48 hours. No only is this incredibly uncomfortable for the patient, it is also extending their hospital stay for at least one day and, sometimes, up to three as they wait for the brace and have it adjusted to fit appropriately. The patient's all have to then wait to work with physical therapy and occupational therapy and, finally, have upright spine films taken in the brace. The braces tend to be very uncomfortably and constricting for patient's and significantly inhibit their daily lives. The investigators are proposing that these fractures can be treated without needing bracewear and will have equivalent to superior outcomes than results while wearing the brace.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any acute, stable thoracic or lumbar compression or burst fracture appropriate for non-operative care
排除标准
- •neurological deficit, pregnant, incarcerated, non-English speaking, previous spinal surgery, additional lower extremity injury affecting weight bearing, younger than 18 years of age
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 6 month post-injury
Primary outcome is the ODI which is a a self-completed questionnaire over ten topics regarding pain, lifting, ability to perform activities of daily living, ability to walk, sit, stand, one's sexual function, social life, sleep quality, and ability to travel. Each category has six different statements from which the patient can choose to best describe their current status. Each question is then scored on a scale from 0-5. Scores are summed and then doubled. The index is from 0-100 with zero being no disability and one hundred being maximally disabled.
次要结局
- PROMIS (Patient-Reported Outcomes Measurement Information System)- physical function(time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- SF-12(time of injury and follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Return to Work Status(follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Visual analog scale (VAS)(Time of injury and at follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years)
研究者
William Behrens, MD
Resident Physician
St. Louis University