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临床试验/NCT01311531
NCT01311531已完成不适用

Treatment of Distal Radial Fractures With Volar Locking Plates Versus Fragment-specific Fixation (TriMed Classic). A Randomized Trial

Region Skane2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
50
试验地点
2
主要终点
Grip strength

研究概览

简要总结

The treatment of unstable, non-reducible distal radial fractures is still controversial. The aim of the present study is to compare the subjective, clinical and radiographic outcome of the TriMed fragment-specific system with a volar locking plate in patients with unstable, non-reducible and also redislocated distal radial fractures.

详细描述

The distal radial fracture is one of the most common fractures, with an annual incidence in southern Sweden of 26 per 10,000 inhabitants (Brogren et al. 2007). Non-surgical treatment, predominantly plaster cast or simple splints, comprises the basic treatment in non-displaced fractures, as well as in displaced, but reducible fractures (Handoll and Madhok 2003). In the unstable, non-reducible distal radial fractures, surgical treatment is necessary but can be complex. The choice of method is still controversial (Chen and Jupiter 2007), especially regarding the result over time (Downing and Karantana 2008). External fixation has been the preferred method of operation for decades, but with the introduction of the volar locking plate technique, internal fixation has rapidly become more and more popular, without any solid foundation in the evidence-based medicine (Margaliot et al. 2005).

We have shown in a randomized study that open reduction and internal fixation of distal radial fractures using the TriMed fragment-specific system resulted in better grip strength and forearm rotation at 1-year follow up than closed reduction and bridging external fixation (Abramo et al. 2009). Later we followed up the same cohort at a mean of 5-years, with the primary aim of determining whether the superior results of internal fixation in unstable distal radial fractures persist over time. The conclusion of this study was that, internal fixation is better than external fixation regarding grip strength and forearm rotation at 1-year but the difference disappears at the 5-year follow-up as both groups approach normal values (Landgren et al. submitted in 2010).

The aim of the present study is to compare the subjective, clinical and radiographic outcome of the TriMed fragment-specific system with a volar locking plate in patients with unstable, non-reducible and also redislocated distal radial fractures. The patients who meet all eligibility criteria and provide consent to participate will be randomly assigned to reduction and fixation with either volar locking plate or Trimed fragment-specific system. Patients will undergo physiotherapy, clinical evaluation, radiographic evaluation at fixed intervals and will also include QuickDASH, VAS, SF-12 and EQ5D. There will be 25 patients in each arm and the patients will be followed for 12 months.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AO type A or C fracture, unstable and non-reducible at day of trauma.
  • AO type A or C fracture, redislocated at the 14 day clinical and radiological control.
  • Incongruent RC-joint or DRU-joint and/or axial compression > 2 mm and/or dorsal compression 20°.

排除标准

  • Previous fracture of the same wrist
  • Volar Barton fractures (AO Type B)
  • Fracture on the other side or other concomitant fracture that also needs treatment.
  • Open fracture
  • Fracture expansion to the diaphysis
  • Ongoing chemo- or radiotherapy
  • Metabolic diseases that affect the bone
  • Dementia, mental illness, alcohol abuse or difficulty understanding the language

结局指标

主要结局

Grip strength

时间窗: 12 months

Will be measured by a physiotherapist at 6 weeks, 3 months and 12 months. Evaluated at 12 months.

次要结局

  • Number of reoperations(12 months)
  • EQ-5D(0, 6 weeks, 3 and 12 months)
  • Forearm rotation (pronation/supination) measured in degrees(6 weeks, 3 months and 12 months)
  • Subjective outcome measured with QuickDASH (scale 0-100)(0, 6 weeks, 3 and 12 months)
  • Visual Analog Scale(0, 6 weeks, 3 and 12 months)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (2)

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