Treatment of Thoracolumbar Spine Fractures: Percutaneously Placed Pedicle Screws Versus Open Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change in Health Related Quality of Life Measure Scores
研究概览
简要总结
In patients presenting with Type A and Type B1, B2 thoracolumbar fractures, there is a lack of evidence demonstrating similar outcomes between patients treated with percutaneous pedicle screws and those treated openly. It has been demonstrated that percutaneous pedicle screw fixation has fared well for patients in the short term; however, it is unclear whether the outcomes are equivalent or inferior/superior compared to open treatment.
The authors seek to establish a high-level evidence base to determine clinical patient outcomes, radiographic outcomes, as well as cost-effectiveness data in comparing thoracolumbar burst fracture patients treated with percutaneous pedicle screws, open treatment, and brace treatment. Additionally, the authors seek to establish data relating to patient occupational data, complications, and need for further surgery (revision/removal of hardware), as well as short-term variables relating to hospital visit (length of stay, estimated blood loss, time under fluoroscopy).
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
- •All patients from ages 18 and older who present to Allegheny General Hospital with an acute thoracolumbar fracture will be considered eligible for the study (i.e. <3 weeks from trauma date).
- •Minor fractures around the fracture site or compression fractures will be permitted if they do not require treatment
- •For the purposes of the study, patients must be English-speaking and live within the 100 mile radius from the greater Pittsburgh area for consent and follow-up purposes
- •Patients who cannot safely undergo brace treatment due to comorbidities such as obesity, pulmonary injury, elderly status, reliability, and multitrauma
- •Patients must have Type A or Type B1,B2 thoracolumbar fracture (must be able to correct deformity through percutaneous instrumentation)
排除标准
- •Patients presenting with a neurologic deficit
- •Patients who receive a laminectomy for decompression of the neural elements
- •Patients who have a significant head injury
- •Oncologic patients
- •Women who were found to be pregnant or breast feeding at any point during their admission, hospital stay, treatment, or clinical follow-up.
- •Individuals who are currently incarcerated.
- •Adolescents under 18 years of age.
- •Patients who have a relative contraindication to operative treatment will be excluded - infection, skin disease, bleeding disorder, etc.
结局指标
主要结局
Change in Health Related Quality of Life Measure Scores
时间窗: 24 months
Oswestry Disability Index, Roland Morris Disability Score, Visual Analog Spine Score, Euroqol 5D-5L
次要结局
- Cost Effectiveness(Duration of Hospital Stay (expected duration average 1 week))
- Additional medical procedures(24 months)
- Return to work(24 months)
- Radiographic Evaluation(24 months)
- Complication rate/Adverse event(24 months)
- Estimated Blood Loss(Duration of hospital visit (expected duration- average 1 week))
- Fluoroscopy time(Duration of hospital stay (expected duration average 1 week))
- Radiographic Evaluations(24 months)
- Length of Hospital Stay(Duration of hospital stay (expected duration average 1 week))
- Operating Time(Duration of hospital visit (expected duration 1 week))
研究者
Daniel Altman
Orthopaedic Surgeon
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)