The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- whether the tibial has obtained union.
研究概览
简要总结
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.
详细描述
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis. The combined surgery includes sleeve resection of the pathological soft tissues, retrograde intramedullary rodding, packaged lilac bone autograft,and appliance of llizarov external fixation device. Bone uion rate,average time of healing, Healing index, ankle valgus, limb length discrepancy, tibia axis alignment are recorded and evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria consists of patients with congenital pseudarthrosis of Tibia
排除标准
- •Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth.
- •Patients with pseudarthrosis of tibia caused by trauma, tumor,infection, etc
- •Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.
- •Parents refused further treatment.
结局指标
主要结局
whether the tibial has obtained union.
时间窗: 6 months post-operation
Ohnishi criterion: Degree of union was evaluated by the findings on radiographs and classified into three grades( Ohnishi criterion): union, delayed union, and nonunion. Radiographic union was defined as possessing continuity of bone density between the fragments without obvious radiolucent zone between them and possessing cortex-bridging fragments with sufficient thickness and radiodensity on both anteroposterior and lateral radiographs. Delayed union was defined as a process of healing that was slow but was progressing. Nonunion was defined by the healing process that had completely ceased.
次要结局
- clinical outcome measurement(Johnston clinical evaluation criterion)(3,6,9,12,18,24 months post-operation)
- Refracture of tibia(0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation)