ISRCTN15537280
已完成
3 期
Ankle Injury Rehabilitation - A multi-centre randomised controlled trial to assess the difference between plaster cast and functional bracing in the management of ankle fractures
niversity of Warwick0 个研究点目标入组 671 人2017年7月24日
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Ankle fracture
- 发起方
- niversity of Warwick
- 入组人数
- 671
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30567826 protocol (added 04/11/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34226192/ (added 07/07/2021) 2021 Results article in https://doi.org/10.1136/bmj.n1506 (added 30/07/2021) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32024789/ Qualitative pre-results (added 06/09/2023)
研究者
入排标准
入选标准
- •1\. Provision of written informed consent
- •2\. Aged 18 years or over
- •3\. A closed ankle fracture for which the treating clinician would consider plaster cast a reasonable management option
- •4\. Within 3 weeks of operative treatment or injury if non\-operatively managed
排除标准
- •1\. Ankle fracture secondary to known metastatic disease
- •2\. Complex intra\-articular fracture (e.g. Pilon fracture)
- •3\. In the opinion of the surgeon the patient would require manipulation and close contact casting
- •4\. In the opinion of the surgeon the patient would require manipulation and moulded cast
- •5\. Wound complications following surgical management contraindicating Functional brace intervention
- •6\. Previous ankle fracture randomised in the present trial
- •7\. Evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires
- •8\. Known pre\-existing neuropathic joint disease contraindicating functional brace intervention
结局指标
主要结局
未指定
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