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UnknownNCT02801149

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
136 (estimated)
Sponsor
Guy's and St Thomas' NHS Foundation Trust · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREWrist Magnetic Resonance Imaging (MRI)Patients that enter this group are randomised to receive non-standard care with a 3-sequence MRI scan of the scaphoid following the initial conventional radiography.

Timeline

Start date
2016-06-06
Primary completion
2018-04-01
Completion
2018-07-01
First posted
2016-06-15
Last updated
2017-08-08

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02801149. Inclusion in this directory is not an endorsement.