Treatement of Extension Fractures of the Distal Radius : Prospective Randomized Postoperative Comparison Between Trans-styloid and Intrafical Pinning on the One Side and Volar Fixed-angle Plating on the Other Side.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction.
研究概览
简要总结
Treatment of extension fractures of the distal radius : prospective randomized postoperative comparison between trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side.
详细描述
Distal radius fractures are more and more numerous. Most of the time, the people concerned are elderly or old with an osteoporotic bone, and an important dorsal metaphysal comminution. The French reference treatment of the extension distal radius fracture, the Kapandji method, turns out to be less and less performing to treat such complicated fractures. At the moment, two points of view are in opposition in France. On the one side, the point of view of those who are in favour of the treatment by intrafocal pinning: they think they will be able to improve their technique if they add a trans-styloid pinning of stabilisation. On the other side, those who are in favour of a treatment using a volar fixed-angle plating.
The purpose of the study is to compare these two types of treatment by using a prospective and randomized analysis.
The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction at tree month.
The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score) at 6 weeks, 3 months and 6 months, as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.
All the patients taken to the emergency ward of Limoges Hospital, and suffering from an extension distal radius fracture (intra or extra articular according to Kapandji classification) will have the possibility to participate in this study, if they want to.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who is affiliated to the NHS (National Health Service)
- •patient who has officially given his consent
- •on over 50 year old patient
- •Patient with an extension fracture of the distal radius
- •patient who is in no condition to express his consent
排除标准
- •patient who is under the protection of justice
- •Patient with an open fracture
- •Patient with an flexion fracture of the distal radius
- •Patient with a metastasis localized in the distal radius
- •traumatised patient
- •patient who is liable not to profit by medical follow-up in Limoges hospital after he has been operated on
- •A pregnant woman / a parturient / a breast-feeding mother
- •patient who is serving a sentence .
- •patient sent to hospital without his consent
结局指标
主要结局
The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction.
时间窗: 3 months
次要结局
- The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score), as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.(6 weeks, 3 months, 6 months)