ISRCTN04180738已完成未知
Comparison of close contact cast (CCC) technique to open surgical reduction and internal fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years: a pragmatic randomised controlled equivalence study
niversity of Oxford (UK)0 个研究点目标入组 620 人开始时间: 2009年5月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 620
研究概览
简要总结
2014 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/24621174 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27727383 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27735787 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31340972 (added 26/07/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men or women aged over 60 years
- •2. Isolated displaced unstable ankle fracture
- •3. Ambulatory prior to the injury - in any capacity
- •4. Capable of giving informed consent
- •5. Capable of adhering to post-operative instructions
- •6. Resident within the catchment area of a recruiting hospital - can attend for 6 month follow up
排除标准
- •1. Established critical limb ischaemia
- •2. Insulin dependent diabetes
- •3. Active leg ulceration
- •4. Open fractures
- •5. Serious contaminant disease - metastatic disease or terminal illness
- •6. Clinically substantial degenerative or inflammatory arthritis
- •7. Unfit for anaesthetic
- •8. Unable to give informed consent - cognitive impairment demonstrated by Mini-Mental State Exam (MMSE) of under 16/30
- •9. Patient unwilling to give informed consent
研究者
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