NCT06542471Enrolling By Invitation不适用
Dual Intramedullary Nailing Fixation Versus Dual Plating of Pediatric Both Bone Forearm Fracture: a Study Protocol for a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- patient satisfaction questionnaire
研究概览
简要总结
A randomized controlled trial to compare between dual intramedullary nailing and dual plating trying to synthesis a high quality evidence study that can solve the conflict between the decisions.
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
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both-bone Forearm Diaphyseal Fracture.
- •age more than or equal nine years old with open distal radius physis.
- •Simple transverse or short oblique fractures (2R2-A2,2R2-A3,2U2-A2,2U2-A3) according to OTA/ AO classification.
排除标准
- •Neurovascular injury.
- •Open fractures
- •Comminuted fractures
- •Pathological fractures
研究组 & 干预措施
group 1
Experimental
Intramedullary nail group
干预措施: Dual intramedullary nailing (Device)
group 2
Experimental
Plating group
干预措施: Dual plating (Device)
结局指标
主要结局
patient satisfaction questionnaire
时间窗: 6 months
five points Likert scale
Time to union
时间窗: 6 months
weeks required to achieve union
Elbow range of motion
时间窗: 6 months
elbow flexion, extension, pronation and supination in degrees
Quick DASH score
时间窗: 6 months
Patient reported questionnaire
次要结局
- size of wound scar in millimeters(6 months)
- Adverse events(6 months)
- Re-operation rate(6 months)
- Deformity (malunion rate)(6 months)
研究者
研究点 (1)
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