ChiCTR2000032843尚未招募1 期
A Randomized Control Trial for Comparing the Patient Reported Outcomes in Distal radius Fractures managed by either cast immbolization or volar locking plate in the edlderl spinal anesthesia
未提供1 个研究点 分布在 1 个国家目标入组 1,096 人开始时间: 2015年2月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 1,096
- 试验地点
- 1
- 主要终点
- Patient Reported Outcomes
研究概览
简要总结
the authors aimed to performed a randomized control trial comparing casting with plating in the elderly population with the hypothesis that plating leads to a better patient satisfaction (SF-12 form), patient reported outcomes (PROMS) and clinical outcomes at 3 months, 6 months, 1-year and 2 year time period.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 60 至 80（—）
- 性别
- All
入选标准
- •The study included patients that were 60 years and above of either gender
- •Other parameters for the participants to be included in the trial were an isolated distal radius fracture (extra-articular or intra-articular) presented to the authors institute within seven days from the time of injury, stable fractures, unstable fractures which were defined as
- •an inadequate initial reduction i.e. not restoring the anatomical parameters or
- •an initial loss of reduction at one week (defined as more than 10° of dorsal angulation of the distal fracture fragment, 3 mm or more shortening of ulnar variance, articular step-off of more than 2 mm)
- •comminuted distal fragment.
排除标准
- •Patients were excluded if they had a sustained an open fracture, bilateral fractures of the distal radius, and ipsilateral limb fractures/injuries, multiple injuries or polytrauma, if they presented more than two weeks after the injury, if the fracture extended more than 3 cm from the radiocarpal joint, impaired wrist function prior to trauma (e.g. rheumatoid arthritis, neurological disorders or previous malunion of the affected limb), if there was a contraindication to anesthesia, patients that could not complete the follow-up period, previous fractures of the wrist or patients that could not follow doctors instructions due to poor cognition such as patients with previous history of stroke or dementia.
研究组 & 干预措施
2
plating
1
cast
结局指标
主要结局
Patient Reported Outcomes
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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