The Use of MRI in the Assessment of Suspected Scaphoid Fracture With Negative Findings on the Initial Plain Radiography (SMRI)

Guy's and St Thomas' NHS Foundation Trust

Status: Unknown

Conditions: Scaphoid Fracture

Treatments: Procedure: Wrist Magnetic Resonance Imaging (MRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02801149

Scaphoid MRI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

No further imaging

No Intervention group

Description:

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)

Experimental group

Description:

Patients randomised to this group will undergo an additional 3-sequence wrist MRI during the initial A\&E/Urgent Care Centre episode.

Treatment:

Procedure: Wrist Magnetic Resonance Imaging (MRI)