Ultrasound Directed Reduction of Colles Type Distal Radial Fractures in ED (UDiReCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Participant recruitment rate
研究概览
简要总结
This is a limited two centre randomized controlled feasibility trial towards a larger definitive trial designed to assess whether bed side ultrasound can reduce the rate of surgical fixation following emergency department manipulation of Colles' type wrist fractures. UDiReCT will mirror the proposed design of the definitive trial but will report feasibility data such as recruitment rate, data completeness and reliability of potential definitive trial outcome measures.
详细描述
Wrist fractures are one of the most common fractures encountered in the Emergency Department (ED). These injuries most frequently happen in people who have fallen onto an outstretched hand and can result in deformity ('displacement') of the broken bone. These 'displaced' (Colles' types of distal radial) fractures can result in long term deformity and problems using the wrist. To prevent this, patients with displaced fractures often undergo manipulation of their fractures, to straighten the wrist, using local anaesthetic or sedation techniques in ED before a plaster cast is applied.
Unfortunately, if ED fracture manipulation is inadequate or the position later 'slips', which can occur in the first 1-2 weeks even in cast, then the patient will need to be admitted to hospital for surgical fixation. Local audit data suggests this affects up to a third of these patients and is a significant additional social and economic burden for patients and healthcare services.
Reducing these fractures as precisely as possible might reduce the subsequent need for surgery. However, ED fracture manipulations are typically done 'blind' with check x-rays after casting, making re-manipulation time consuming with prolonged local anaesthetic times or need for re-sedation. Portable, bedside ultrasound is available in most departments and has been used to guide fracture reduction but it is not known how effective this is nor is it in routine use. Providing this evidence would require a large, multi-centre randomized controlled trial (RCT) trial.
This project aims to determine whether such a trial comparing current practice with ultrasound guided reductions is justified and feasible. This will be done by running a feasibility RCT across two United Kingdom (UK) hospital sites to assess recruitment rates and trial procedures. The investigators hope to recruit about 60 patients in 6 months. This trial will include adults' aged 18 years and older, with Colles' type of distal radial fractures requiring manipulation in ED.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Sham ultrasound will be conducted in control group with screen off and facing away from participant.
Active US screen will also be turned away from participant in the US allocated group and no discussion allowed about the image.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with Colles' type fractures of the distal radius undergoing fracture manipulation in the ED
- •UDiReCT Trial trained staff available
排除标准
- •Age under 18
- •Volar displaced (Smith's) type fractures (well established as being unstable and requiring surgical treatment)
- •Unable or unwilling to give informed consent
- •Unable or unwilling to be followed up (e.g. orthopaedic follow up in another region)
- •Major trauma with other injuries and ISS (Injury Severity Score) >16
- •Urgent manipulation required due to neurovascular or skin compromise
- •Open fractures or those with associated nerve or tendon involvement (affect functional outcome)
- •Prisoners
研究组 & 干预措施
MUA with sham ultrasound
Participants will undergo standard manipulation (MUA) of wrist fracture with sham ultrasound (screen concealed from participants)
干预措施: MUA with sham ultrasound (Procedure)
MUA with active ultrasound
Participants will undergo standard manipulation (MUA) of wrist fracture with active ultrasound (screen concealed from participants)
干预措施: MUA with active ultrasound (Procedure)
结局指标
主要结局
Participant recruitment rate
时间窗: 6 months
Number of participants recruited over the duration of the study
次要结局
- Data completeness.(6 months)
