RCT Comparing the Efficacy of POP Cast vs Woodcast for Distal Radial Fractures in Children.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Woodcast effectiveness versus traditional cast
研究概览
简要总结
The investigators project is a randomised controlled trial that will compare the efficacy of the traditional casting method against the woodcast splint in distal radial fracture. After the investigators have taken consent and the patients have agreed to be a part of the project, the investigators will randomly divide the participants into two groups. One with the traditional cast and one with the wood cast. The difference will be measured by using the EQ-5D-Y tool alongside the use of the DASH score and our own questionnaire.
The study will take place over the following year with the Sheffield Children's Hospital being the only site involved. Woodcast products have the CE declaration of conformity which is covered for the use in children, and apart from the type of cast the child is given, the course of treatment is the same for both group
详细描述
Distal radial fractures are a very common fracture. Without good plaster immobilisation these fractures are prone to slipping. As a result, patients may end up with surgical treatment which would otherwise not be needed if the plaster were to hold the fracture position adequately. If one was shown to be better compared to the other, then all hospitals could start to use a more effective treatment.
With traditional casting, some of the details of the fracture are missed due to the shadowing on the x-ray. The woodcast aims to reduce this shadowing, allowing a more detailed image of the fracture and hopefully a better outcome. Problems may arise with the plaster cast, at one or two week scans, in which the cast may need to be removed for imaging, this could lead to displacement of the fracture effecting the outcome. Woodcast would potentially not need to be removed or is easily removed due to the fact that it is not a complete cast and so would hopefully improve the outcomes for the patient.
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
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 3 and 16 that present with a distal radial fracture.
排除标准
- •Patients with underlying physical and learning disabilities.
- •Patients with significant co-morbidities that would put the patient at risk of extra distress.
- •Pathological fractures for instance Osteogenesis Imperfecta, metabolic bone diseases etc...
- •Patients who aren't fluent in English as we only have questionnaires available in English.
结局指标
主要结局
Woodcast effectiveness versus traditional cast
时间窗: 3 months
To measure the displacement of the fracture seen on the x-ray, comparing those in the traditional cast and those in the Woodcast.
Woodcast effectiveness
时间窗: 3 months
Whether the cast needs to be changed during the course of the treatment.
Woodcast effectiveness measured by self designed patient response questionnaire. Score not reported on a scale
时间窗: 3 months
Whether the woodcast is comfortable to the patient
次要结局
未报告次要终点