"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures: Is Six Weeks as Safe as 12 Weeks? (A Randomized, Clinical Trial.)"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Fracture healing
研究概览
简要总结
Most fractures of the cervical spine are considered stable and treated with a rigid cervical collar. However no studies have to date been published addressing the length of treatment. There seems to be a significant dissimilarity between hospitals within and between countries with the length of collar treatment varying from 6 to 12 weeks. At the neurosurgical department at Oslo University Hospital, Ullevål the standard length of treatment for a stable cervical fracture is 12 weeks. This study seeks to establish whether 6 weeks of collar treatment for a specific subtype of stable fractures in the cervical spine is sufficient.
详细描述
The investigators will include 150 patients with a stable cervical fractures of vertebra C3-C7 with a Subaxial Cervical Spine Injury Severity (SLIC) Score 1-3 and randomize them in to two similar groups. One group will be treated with a cervical collar for 6 weeks and the other group will be treated for 12 weeks. There will be a clinical check up and a CT scan at 1, 6, 12 and 26 weeks after the initial injury. The investigators will compare the results between the two groups when it comes to fracture healing (CT based), level of function, pain and the length of sick leave with a total of 6 months of follow up.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a newly diagnosed (within 5 days of injury) fracture in vertebra C3-C7 with SLIC score 1-3
- •Patients must be abel to give their consent to participate in the study
排除标准
- •Unstable cervical fractures in need of surgery
- •SLIC score >3
- •Fractures of the spinous process and the transverse process in the cervical spine
- •Stable fractures in in the C3-C7 vertebra combined with fractures of the C0-C2 vertebra
- •Pathological fractures in the cervical spine
研究组 & 干预措施
6 weeks
This group of patients will be treated for 6 weeks with a cervical collar (Miami J collar - Össur)
干预措施: Cervical collar (Miami J collar - Össur) (Device)
12 weeks
This group of patients will be treated for 12 weeks with a cervical collar ( (Miami J collar - Össur)
干预措施: Cervical collar (Miami J collar - Össur) (Device)
结局指标
主要结局
Fracture healing
时间窗: 6 months
The fracture healing will be assessed based on CT scans at 6 months
Visual analogue scale - neck pain and radiculopathy
时间窗: 6 months
Pain will be assessed at 6 months based on the Visual Analogue Scale and the use of pain medication will be recorded at 6 months
次要结局
- Level of function(6 months)
- Treatment failure(6 months)
研究者
Christina Høstmælingen
MD
Oslo University Hospital