A Single Centre Randomised, Non-blinded, Prospective Study to Evaluate the Use of MRI for Patients Presenting With Suspected Scaphoid Fracture With Negative Findings on the Initial Conventional Radiography
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- 3-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode
研究概览
简要总结
Given that: 1) various clinical complications may arise from a misdiagnosed scaphoid fracture; and 2) clinical and radiographic diagnosis of scaphoid fracture is often challenging, particularly at the time of presentation, this study aims to evaluate whether the use of Magnetic Resonance Imaging (MRI) in the investigation of patients presenting with a suspected scaphoid fracture, with negative findings from the initial conventional radiography (4-view plain x-ray), leads to improved levels of efficiency, quality of care and patient experience.
This study is a single centre randomised, non-blinded, prospective study. Participants will be randomised, following the initial negative conventional radiography, to either: no further imaging at A&E (consistent with current clinical practice); or 2) wrist MRI. The study considers a follow-up period of 6 months.
详细描述
The scaphoid bone is an obliquely orientated bone on the radial (thumb) side of the wrist, between the distal carpal row and the radius. Wrist injury is a common presentation to the Emergency Department (ED) in the UK. Amongst these patients, the scaphoid is the most commonly fractured carpal bone, accounting for 51-90% of carpal fractures and between 2-7% of all fractures.
Given that: 1) various clinical complications may arise from a misdiagnosed scaphoid fracture; and 2) clinical and radiographic diagnosis of scaphoid fracture is often challenging, particularly at the time of presentation, this study aims to evaluate whether the use of Magnetic Resonance Imaging (MRI) in the investigation of patients presenting with a suspected scaphoid fracture, with negative findings from the initial conventional radiography (4-view plain x-ray), leads to improved levels of efficiency, quality of care and patient experience.
This study is a single centre randomised, non-blinded, prospective study. Participants will be randomised, following the initial negative conventional radiography, to either: no further imaging at A&E (consistent with current clinical practice); or 2) wrist MRI. The study considers a follow-up period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Every patient aged 16 years or over presenting at A&E/UCC with clinical history and examination consistent with a suspected scaphoid fracture but negative findings on the initial 4-view plain x-ray. It is considered that a patient has suspected scaphoid fracture if at least one of the following criteria are present:
- •Isolated pain / tenderness over the Anatomical Snuff Box (ASB) or Scaphoid Tubercle or pain in the scaphoid region during axial loading of the 1st metacarpal.
- •History of recent fall (< 14 days) on an out-stretched hand (FOOSH), wrist injury or poor history associated with examination findings suggestive of scaphoid fracture.
- •Furthermore, only patients that present at A&E/UCC during the following schedule of MRI normal working hours will be included in the study:
- •Patients screened for the study at A&E/UCC on weekdays after 7.30 am and before 6 pm;
- •Patients screened for the study at A&E/UCC on weekends or Bank Holidays after 9 am and before 4 pm.
排除标准
- •Patients presenting outside GSTT's catchment area who are not willing to be followed-up at GSTT;
- •Patients with a confirmed scaphoid fracture following the initial 4-view plain x-ray;
- •Patients with confirmed ipsilateral upper limb injury/injuries (e.g. wrist/forearm/arm injury) following initial conventional x-ray examination(s) - regardless of the findings around the suspected scaphoid fracture.
- •Patients with suspected scaphoid fracture not admitted through A&E at St Thomas' Hospital or Urgent Care Centre (UCC) at Guy's Hospital;
- •Patients who lack capacity to give consent or participate in the study;
- •Patients that are already taking part in a Clinical Trial of an Investigational Medicinal Product (CTIMP);
- •Prisoners.
研究组 & 干预措施
No further imaging
Patients randomised to this group will receive standard care, i.e. will not undergo additional imaging scans at A&E/Urgent Care Centre.
Wrist Magnetic Resonance Imaging (MRI)
Patients randomised to this group will undergo an additional 3-sequence wrist MRI during the initial A&E/Urgent Care Centre episode.
干预措施: Wrist Magnetic Resonance Imaging (MRI) (Procedure)
结局指标
主要结局
3-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode
时间窗: 3 months
The primary objective is to estimate the 3-month costs associated with two clinical pathways at A\&E/UCC: (i) the current pathway, with x-ray as the only imaging modality (no further imaging group); or (ii) the proposed pathway (MRI group), with a hybrid approach i.e. using x-ray as the initial imaging modality and subsequently MRI for patients with negative findings on the initial x-ray.
次要结局
- Cost per correctly diagnosed scaphoid fracture (measured in £ per correct diagnosis)(3 months)
- 3-month cost-effectiveness analysis (ICER measured as £ per QALY) following the A&E/UCC initial episode(3 months)
- 6-month cost-effectiveness analysis (ICER measured as £ per QALY) following the A&E/UCC initial episode(6 months)
- Time off work or informal care needs (measured in days) due to the suspected scaphoid fracture.(3 months)
- Patient satisfaction in both groups (to be assessed using non-standard questionnaires, based on a 1-5 likert scale)(3 months)
- Likelihood ratio of the proposed pathway (i.e. wrist MRI group) in the detection of scaphoid fracture compared to the current pathway (no further imaging group)(3 months)
- Percentage of agreement between radiographers and radiologists in the diagnosis of suspected scaphoid fractures(1 week)
- 6-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode(6 months)
- Time (measured in days) taken to reach a definitive diagnosis and the first major treatment decision based on the MRI in comparison to the current pathway(3 months)