Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- Roland-Morris Disability Questionnaire (RMDQ)
研究概览
简要总结
Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants. The majority of these fractures are AO type A3 ("burst fractures"). Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes. The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial. The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18-65 years
- •Diagnosis of single or multiple stable thoracolumbar fracture(s)
- •Level T10- L3
- •Type AO A3 or A4
- •Radiologically confirmed by Rx or CT
- •Fracture induced kyphotic deformity lower or equal to 20-35 degrees
- •Definitive treatment (surgical or conservative) within 10 days after injury
- •American Spinal Injury Association (ASIA) Impairment Scale = E (normal )
- •Ability to understand patient information / informed consent form
- •Willingness and ability to participate in the clinical investigation including imaging and follow-up procedures (FUs)
- •Signed informed consent
排除标准
- •Open fracture
- •Polytrauma
- •Pathologic fracture
- •Disruption of the posterior ligamentous complex between T10 and L3
- •Clinically evident osteoporosis as assessed by the investigator
- •Spinal luxation
- •Associated severe lesions as assessed by the investigator
- •Spinal lesion due to gun or projectile
- •Pre-existing spinal column deformity
- •Prior spinal surgeries
- •BMI > 40 kg/m2
- •Any severe medically not managed systemic disease
- •Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reli-able assessment
- •Pregnancy or women planning to conceive within the study period
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
结局指标
主要结局
Roland-Morris Disability Questionnaire (RMDQ)
时间窗: 6 week follow up
Improvement in functional outcome from baseline to 6 week follow up (FU) measured with the Roland-Morris Disability Questionnaire (RMDQ)
次要结局
- Quality of return to work (Denis Work Scale)(Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up)
- Rates of local adverse events (AE)(Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up)
- Pain (Numeric Rating Scale (NRS))(Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU)
- Radiologic progress taking into account RX, CT and optionally MRI(baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months)
- Time to return to work(Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up)
- Conservative treatment failure rate (eg, change to surgical treatment)(Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up)
- Back pain related disability (Roland-Morris Disability Questionnaire RMDQ)(Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up)