CTRI/2020/05/025264尚未招募1 期
Volar Plate Versus K-Wire Fixation in Intra-Articular Fracture of Distal Radius
GAURAV CHATTERJEE1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年5月25日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.MAYO wrist score
研究概览
简要总结
OBJECTIVE:
Tocompare the two procedures: percutaneous k-wire fixation and open reductioninternal fixation with volar plating in treatment of distal radiusintra-articular fractures.
HYPOTHESIS:
Betterfunctional outcome is achieved with open reduction and volar plating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Articular fractures: AO type B & type C1-2 2.Age >18years i.e. skeletally mature 3.Isolated lesions 4.>15 degree displacement on lateral plane 5.>5mm radial shortening on frontal plane 6.Minimum of 2mm of either gap or step off.
排除标准
- •1.Open fractures and neuro-vascular lesions 2.Ipsilateral upper extremity associated lesions 3.Previous history of fracture of the wrist 4.Patients with congenital anomaly of the wrist.
结局指标
主要结局
1.MAYO wrist score
时间窗: 3 MONTHS | 6 MONTHS | 12 MONTHS
2.DASH score
时间窗: 3 MONTHS | 6 MONTHS | 12 MONTHS
次要结局
- 1.Age {young/old}(2.Sex {male/female})
研究者
研究点 (1)
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