Internal Fixation Versus Casting of Displaced Tibial Shaft Fractures in Children and Dolescents: a Study Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Malunion
研究概览
简要总结
Tibial shaft fracture is a common fracture in the pediatric and adolescent population. The outcomes of both conservative and operative treatment are not clear and to date there is no randomized prospective trial comparing different methods of treatment.
The investigators will conduct a multicenter, randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis.
详细描述
Introduction
Tibial shaft fracture is a common fracture in the pediatric and adolescent population. Displaced tibial shaft fractures have traditionally been treated with closed reduction and cast immobilization. Amount of surgically treated fractures have increased notably especially since flexible intramedullary nails have gained increasing popularity. The outcomes of both conservative and operative treatment are not clear and to date there is no randomized prospective trial comparing different methods of treatment.
To this date there is no randomized controlled study comparing non-operative and surgical treatment of tibial fracture in children and adolescent. The null hypothesis is that intramedullary nailing of displaced tibial shaft fractures in 7-15 year old skeletally immature pediatric and adolescent patients is superior to cast immobilization in maintaining correct alignment during fracture healing and in restoring of normal functions of the injured limb.
Methods and analysis
The Investigators will conduct a multicenter, randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis. A total of 60 patients will be randomly assigned 1:1 ratio to closed reduction and cast immobilization or internal fixation with flexible intramedullary nails. Investigators will follow the patients 10 years and compare results at baseline and each follow up. The primary outcome will be radiographic union at good alignment at one year. The secondary outcomes include PedsQL (Pediatric Quality of Life Inventory), number of re-interventions, length of hospital stay, complications, and volume of injured extremity compared with uninjured leg. Patients unwilling for randomization will be asked to participate in a paraller prospective cohort. The null hypothesis is that intramedullary nailing is non inferior to conservative treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 to 15-year old children with displaced tibial shaft fracture
排除标准
- •Open fracture
- •Compartment syndrome
- •Neurovascular deficit
- •Pathological fracture
- •Systemic disease affecting bone structure and quality
- •Associated injuries preventing either casting or intramedullary nailing.
结局指标
主要结局
Malunion
时间窗: one year
malunion described as coronal angulation over 5 degrees, sagittal angulation over 10 degrees, over 50% cortical overlap and over 1 cm shortening.
次要结局
- complication(two year follow up)
- Pediatric Quality of Life Inventory(one year)
- number of reinterventions(two year follow up period)