The Thoracolumbar AOSpine Injury Score: Clinical And Radiological Outcomes Of Management Of Fractures Having Scores Of 4 And 5: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Between December 2019 to December 2022, patients presenting to causalty department with TL fracture type A3 and A4 with a TL AOSIS scores of 4 and 5 were randomly managed either by conservative or operative management.
详细描述
Conservative management group was treated by bed rest and brace for 3 weeks followed by early mobilization. Operative management group received management through Short-segment fixation with one or two screws in fractured vertebra when applicable with posterior spinal fusion. Patients were evaluated both clinically regarding pain (VAS score), disability by Oswestry Disability Index (ODI score) and neurological status. Radiological evaluation included local sagittal spinal alignment, including pre- and post- management Cobb angle and local segment kyphosis. Bony fusion was also evaluated.
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
- 21 Years 至 57 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature patients (age 21-55 years old), TL spine fractures of types A3 and A4 with TL AOSIS score 4 or
- •These include different variables; A4N0, A3N1, A3N2 and A3M1N0.
排除标准
- •Osteoporotic fractures and skeletally immature patients, associated comorbidities (e.g. bleeding disorders, rheumatoid arthritis), or any fracture type other than A3 and A4, and significant neurological compromise.
研究组 & 干预措施
conservative group
干预措施: conservative management (Procedure)
operative group
干预措施: short segment TPF (Procedure)
结局指标
主要结局
Pain score
时间窗: 6 months
VAS score
deformity
时间窗: 1 year
Cobb angle
healing
时间窗: 6 months
radiological union
次要结局
- function(1 year)
研究者
Ahmed Hamed Kassem Abdelaal
Dr.
Sohag University