Clinical trial NCT02801149: The Use of MRI in the Assessment of Suspected Scaphoid Fracture With Negative Findings on the Initial Plain Radiography
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scaphoid Fracture
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2016-06-15
Enrollment: 136
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 3-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode
timeFrame: 3 months
Secondary outcomes:
measure: 6-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode
timeFrame: 6 months
measure: 3-month cost-effectiveness analysis (ICER measured as £ per QALY) following the A&E/UCC initial episode
timeFrame: 3 months
measure: 6-month cost-effectiveness analysis (ICER measured as £ per QALY) following the A&E/UCC initial episode
timeFrame: 6 months
measure: Cost per correctly diagnosed scaphoid fracture (measured in £ per correct diagnosis)
timeFrame: 3 months
measure: Patient satisfaction in both groups (to be assessed using non-standard questionnaires, based on a 1-5 likert scale)
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Percentage of agreement between radiographers and radiologists in the diagnosis of suspected scaphoid fractures
timeFrame: 1 week
measure: Time off work or informal care needs (measured in days) due to the suspected scaphoid fracture.
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Sam Gidwani
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rua T, Vijayanathan S, Parkin D, Goh V, McCrone P, Gidwani S. Rationale and design of the SMaRT trial: A randomised, prospective, parallel, non-blinded, one-centre trial to evaluate the use of magnetic resonance imaging in acute setting in patients presenting with suspected scaphoid fracture. Clin Trials. 2018 Apr;15(2):120-129. doi: 10.1177/1740774517748320. Epub 2018 Jan 24.