NCT00725894已完成不适用
A Prospective Multi-Center Clinical Outcomes Study To Assess The Safety and Effectiveness Of The Pediatric Locking Nail For Treatment Of Femoral Fractures In Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- limb alignment
研究概览
简要总结
The purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, representative willing to sign informed consent.
- •Ability and willingness of the subject to follow postoperative care instructions until healing is complete
- •Subject age must be between 8-16 inclusive.
- •Subjects with a minimal canal diameter of 9mm or greater
- •And any of the following fracture types
- •Non-comminuted and comminuted mid-shaft fractures
- •Distal third fractures 4 cm above the distal physis
- •Fractures that are open or closed
- •Subtrochanteric fractures
排除标准
- •A subject has a bone or soft tissue infection.
- •Subject has a systemic infection.
- •Subject has a distal (supracondylar) fracture.
- •Subject with pathological bone (osteogenesis imperfecta and other conditions resulting in abnormal bone quality).
- •Subjects with mental or neurological condition who are unwilling or incapable of following postoperative care instructions.
- •Subject with conditions including blood supply limitation, and insufficient quantity or quality of bone.
- •Foreign body sensitivity, where material sensitivity is suspected, testing is to be completed prior to implantation of device if at all practical or the subject should be excluded.
结局指标
主要结局
limb alignment
时间窗: 48 months
次要结局
- length of healing, weight-bearing time (time to full weight bearing), and length of hospital stay and absence of complications(48 Months)
研究者
研究点 (3)
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