Randomised Controlled Trial on Surgical vs Non-surgical Treatment of Type II Odontoid Fracture Treatment in the Elderly
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Neck Disability Index (NDI questionnaire)
研究概览
简要总结
A multicenter randomized controlled trial is performed in Sweden (Uppsala, Malmo and Stockholm) comparing surgery with posterior C1-C2 fusion and conservative treatment with a rigid collar. Follow up will be performed up to one year after start of treatment registering EQ5D, NDI and cervical CT scans. Mortality will be documented during follow-up. All direct and indirect costs of treatment will be registered and used for cost-effectiveness analysis.
详细描述
50 patients, based on the following calculation of study size: The standard deviation for Neck Disability index, NDI, is just under 7, while "minimally clinical important difference" (MCID) is 7 points . That gives that 16 patients are needed in each group to get 80% power with a significance level of 5%. However, in the studied population the one year mortality rate is substantial, especially after a neck injury . In order to be able to draw conclusions from the study the investigators have elected to expand the study to 25 subjects in each group.
Follow up: 1w, 6w, 3m, 1y with CT, Questionaires: NDI, EQ5D. Bone density measurement at injury. Extension flexion x-ray after 1 year.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute displaced odontoid fracture type II according to Anderson and D'Alonzo, age 75 years or older. Displacement defined as 4 mm anterior translator displacement, any posterior translator displacement, or 10 degrees of angulation.
排除标准
- •Any contraindication to surgery, anesthesia class ASA 4 or higher (Saklad 1941), severe senile dementia (defined as being admitted to a nursing home or hospital because of the dementia), anatomical or other prerequisites that makes an operation unsuitable.
研究组 & 干预措施
Surgical treatment
Stabilization of odontoid fracture with posterior fusion C1-C2
干预措施: Posterior fusion C1-C2 (Procedure)
Conservative treatment
External stabilization of odontoid fracture with a rigid cervical collar for 3 months.
干预措施: Rigid cervical collar (Procedure)
结局指标
主要结局
Neck Disability Index (NDI questionnaire)
时间窗: 1 year
次要结局
- EQ5D questionnaire(1 year)
- Number of participants that deceased after inclusion(1 year)