NCT01047826Unknown不适用
Intramedullary Nailing vs. M.I.P.O. in Fractures of the Tibia a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Rate Of Malunion
研究概览
简要总结
The investigators are comparing two methods of standard treatments in distal tibial fractures. locked plating (M.I.P.O. technique) with intramedullary nailing.
the investigators are hypothesizing that M.I.P.O group is superior to nailing in fractures of the distal third of the tibia.
详细描述
The kind of plates the investigators are comparing are the Locked plates form Synthes ® using the minimally invasive technique vs the Expert Tibial Nail® from Synthes ®
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females aged from 18-60 years
- •Closed Tibia Fracture
- •Tibia Fracture Müller AO Class 43-A
排除标准
- •Intra-articular Fractures
- •Open fractures
- •fracturesSubjects with documented Marfan's syndrome or Ehlers-Danlos syndrome or Hajdu-Cheney syndrome.
- •Post organ transplant patients (except Cornea transplant)
- •Subjects on immunosuppressive medications
- •Subjects with diagnosed with
- •Osteogenesis imperfecta
- •Osteopetrosis
- •Paget disease of bone
- •Renal osteodystrophy
- •Subjects with diagnosed neoplasms or mitotic illnesses
- •Subjects receiving growth hormone
- •Unable to comply with postoperative rehabilitation e.g. head injury
- •Impending compartment syndrome
结局指标
主要结局
Rate Of Malunion
时间窗: 6 months
Any healing that occurs with any one of the following: More than 5 degree angulation in the anterior-posterior or lateral view or Rotation of more than 10 degrees or Shorting of more than 1 cm.
次要结局
- Blood Loss(during the time of surgery)
- The Short Form (12) Health Score (SF-12v2®)(every 3 months till healing or 24 months)
- Radiation exposure(During the time of Surgery)
- Duration of Surgery(During the time of Surgery)
- Infection Rate(every 3 months till healing or 24 months)
- Hospital Stay(After Surgery)
- Time Of Fracture Healing(6 months)
研究者
研究点 (2)
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