Thoracolumbar Burstfractures, Orthesis or no Orthesis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Functional score
研究概览
简要总结
Rationale: Thoracolumbar burst fractures are frequently seen in the trauma population, they have a large impact on patient's wellbeing and are a large economic burden to society. Thoracolumbar burst fractures might not need the standard care of brace immobilization for adequate treatment and a functional treatment might lead to same or better functional outcomes. Besides that, with functional outcome length of hospital stay might decrease and it might also be cost effective compared to bracing.
Objective: The investigators aim to study the use of braces for thoracolumbar burstfractures, not only by measuring the functional scores and the effect of the bracing or functional treatment on the increase in kyphosis angle, but also on (health related) quality of life and health economics. The investigators hypothesize that no treatment is superior over one other.
Study design: This project is a randomised controlled trial comparing brace and no brace treatment on function, kyphosis angle, pain, quality of life, and costs.
Study population: Patients between 18 and 65, with a single level thoracolumbar burst fracture will be included. The fracture has to have a kyphosis angle of less than 35 degrees and patient has to be neurologically intact. Patients are excluded when they are overweight (BMI> 35), need multidisciplinary treatment due to multitrauma, or have inadequate knowledge of the Dutch language. Patients included in the brace group will automatically take part in a brace compliance study.
Intervention: One group receives a Thoracolumbar Sacral Orthesis (TLSO) for 6 weeks, the other group receives no TLSO Main study parameters/endpoints: The primary outcome of this study is the functional score at six months after trauma. Secondary outcomes are pain, kyphosis angle, health related quality of life, healthcare costs and brace compliance.
Literature shows no difference in pain, functional outcome or kyphosis angle, therefore no potential risks are known comparing a brace and a functional treatment. Investigators aim that not using the TLSO results in similar functional outcome, pain and kyphosis angle, and less costs. Patients will be seen at first presentation and during two year follow up at the outpatient clinic at six standard care follow up moments. At these follow up moments a X-ray as part of standard care is made. At or just before each scheduled appointment they will fill in questionnaires taking from 15-45 minutes.
详细描述
No extra information
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AO foundation type A3 or A4 type fractures
- •Single level
- •Kyphosis < 35 ° at first analysis
- •Neurologically intact
- •Adequate trauma
排除标准
- •Inadequate knowledge of the Dutch language
- •Multitrauma, which asks for multidisciplinary treatment
- •Inability to wear a brace due to overweight (BMI> 35)
- •Known osteoporosis
结局指标
主要结局
Functional score
时间窗: at six months, measured up to two years
Oswestry Disability Index (ODI) derived from the Oswestry Low Back Pain Questionnaire used to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
次要结局
- Patient reported health status(up to two years)
- Pain(up to two years)
- Medical Consumption(up to two years)
- Productivity costs(up to two years)
- Work Ability(up to two years)
- Quality of life score(up to two years)
研究者
Wouter Bakker
drs.
Elisabeth-TweeSteden Ziekenhuis
