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

NCT02801149 | Unknown DMC

• 1 other identifier: Scaphoid MRI
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Scaphoid Fracture

Outcome Measures

Primary Outcomes (1)

• 3-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode

  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.

  3 months

Secondary Outcomes (9)

• 6-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode

  6 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

• Cost per correctly diagnosed scaphoid fracture (measured in £ per correct diagnosis)

  3 months

• Patient satisfaction in both groups (to be assessed using non-standard questionnaires, based on a 1-5 likert scale)

  3 months

Study Arms (2)

No further imaging

NO INTERVENTION

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

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

Procedure: Wrist Magnetic Resonance Imaging (MRI)

Interventions

Wrist Magnetic Resonance Imaging (MRI) PROCEDURE

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.

Wrist Magnetic Resonance Imaging (MRI)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 29366329 DERIVED

Study Officials

• Sam Gidwani

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bharti Malhotra, MSc

CONTACT

bharti.malhotra@kcl.ac.uk

Tiago Rua, MSc

CONTACT

tiago.rua@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 15, 2016
• Study Start: June 6, 2016
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)