An open labelled randomized control trial comparing short term outcomes in thoracolumbar fractures without neurological deficit and without obvious posterior ligamentous complex injury treated by percutaneous fixation vs no fixation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- In patients of thoracolumbar fractures without obvious PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, To compare the intensity of pain (measured by vas score) between the 2 groups at the end of 3 weeks since time of injury.
研究概览
简要总结
This study is a randomized, open labelled , parallel group, single center trial comparing short term outcomes in patients of thoracolumbar fractures without neurodeficit and without posterior ligamentous complex(PLC) treated operatively by percutaneous pedicle screw fixation vs those treated non operatively. patients who satisfy the inclusion criteria will be explained the details of the study and consent taken for participation. following which he will be randomized and respective group will be alloted. patient will then undergo the respective SOP(standard operative procedure - i.e operative management for operative group and conservative management for conservative group) followed for the particular group. thereafter he will be discharged and asked to followup at the end of three weeks since injury, for assessment of outcomes, i.e. primary outcome - pain measure by vas score, secondary outcomes - disability (measured by EUROQOL 5L, ODI score, return to work, analgesic useage), radiological outcomes(cobbs angle), any complications that arise in the two study arms. following the assessment patient will be kept on regular follow up as per institutional guidelines for management of these group of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults of both sexes aged 18 years or over, with a radiologically confirmed, recent (less than or at one week) isolated thoracolumbar fracture without neurodeficit and obvious PLC injury.
排除标准
- •ANY Patients with a preferred choice of treatment modality Polytrauma patients Patients with other associated musculoskeletal trauma Pathological fractures of vertebral body.
- •Previous spine surgeries.
- •Presence of back pain prior to thoracolumbar fractures.
- •Patients with obvious PLC disruption on radiological evaluation Pregnant patients.
结局指标
主要结局
In patients of thoracolumbar fractures without obvious PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, To compare the intensity of pain (measured by vas score) between the 2 groups at the end of 3 weeks since time of injury.
时间窗: 3 weeks since time of injury.
次要结局
- In patients of thoracolumbar fractures without PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, to compare between the 2 groups, the extent of disability measured by ODI score, EUROQOL-5D, return to work (Denis work scale), number of days of hospital stay and analgesic usage at end of 3 weeks since time of injury
- In patients of thoracolumbar fractures without PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, To compare between the 2 groups the radiological outcome measured by cobbs angle at the end of 3 weeks.(3 weeks since time of injury.)
- In patients of thoracolumbar fractures without PLC injury and without neurological deficit, treated by percutaneous fixation vs no fixation, To identify and record any complications arising due to treatment irrespective of which treatment given among the two groups at the end of 3 weeks(3 weeks since time of injury.)
