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临床试验/NCT02990052
NCT02990052已完成不适用

Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial

University of Oulu0 个研究点目标入组 80 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
Difference of DASH-score between two study groups

研究概览

简要总结

A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture

详细描述

Volar plating has became as a standard approach for treating unstable distal radius fractures. The incidence of surgically treated patients with distal radius fractures has increased many fold from the beginning of this millennium, owing mostly to increased number of volar platings. The most striking increase of plate fixations has occurred in older patient groups, especially in females. With volar fixed-angle plate, very near-anatomic, stable fixation with relatively low complication rate, can be achieved even in osteoporotic bone. There are only few randomized, prospective studies comparing results of volar plating and conservative treatment, comparing patients aged over 65 years. Quite little is known of the results comparing conservative treatment and volar plating in patients aged below 65 years.

Main goal of our study was to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture in patients aged over 50 years an older.

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

入选标准

  • patients over 50 years-old
  • primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2)
  • primary reduction of fracture is acceptable considering primary conservative treatment

排除标准

  • bilateral and open fractures and fractures with neurovascular compromise
  • other major concurrent fracture necessitating treatment of any kind
  • patients under 50 years of age
  • previous ipsilateral distal radius fracture
  • inflammatory joint disease
  • significant radiocarpal-joint degeneration
  • patient's bad co-operation or major co-morbidity making an operation contraindicated

结局指标

主要结局

Difference of DASH-score between two study groups

时间窗: 2 year observation

Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity

次要结局

  • Difference of radiological parameters between two study groups(2 year observation)

研究者

申办方类型
Other
责任方
Sponsor

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