Pilot Study to Test the Feasibility of the Use of MRI in Suspected Scaphoid Fractures

NCT ID: NCT02605096

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2016-04-01

Brief Summary

This pilot study aims to test the feasibility and work flows associated with using MRI as the initial imaging modality in the investigation of patients presenting with suspected scaphoid fracture.

This pilot will be used to inform the design of a study that will aim to evaluate whether the proposed intervention is likely to generate cost-savings whilst improving or maintaining overall patient quality of life and satisfaction.

Detailed Description

The present pilot study is designed to assess the feasibility of using MRI as the initial imaging modality in the investigation of patients presenting with suspected scaphoid fracture at the Emergency department or Urgent Care Centre. This study will inform the design of a study that will aim to evaluate whether the proposed intervention is likely to generate cost-savings whilst improving or maintaining overall patient quality of life and satisfaction.

Patients with a suspected scaphoid fracture will be randomised to receive standard of care using 4-view plain x-ray (control group) as the first imaging modality or MRI examination as the first imaging modality.

Conditions

Scaphoid Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRI group

This arm assess the use of MRI as the first line examination of suspected scaphoid fracture (replacing conventional plain x-ray).

Patients with negative findings will receive a splint and contact card to a specialist wrist clinic if the pain persists for ten to fourteen days after initial presentation.

Patients with positive findings will receive a plaster cast and undergo a CT scan (to evaluate displacement) and will be referred to the fracture clinic. Furthermore, if the CT scan confirms a displaced fracture, that might require surgery, the patient should be seen by a Hand Specialist at fracture clinic.

All patients enrolled in the pilot should undergo a 4-view plain x-ray 3 months after the initial ED/UCC presentation.

Group Type: EXPERIMENTAL

MRI

Intervention Type: PROCEDURE

Magnetic Resonance Imaging Scan

X-ray group

This arm is the current standard of care pathway for the diagnosis of patients with suspected scaphoid fracture. This includes an initial clinical assessment on arrival to the Emergency Department of Urgent Care Centre followed by a plain x-ray (using a 4-view scaphoid protocol).

Patients with negative/positive findings for scaphoid fracture in the initial X-ray will be immobilised with a splint/plaster cast.

All patients will be referred to an initial fracture clinic and a proportion of patients are likely to require additional imaging scans (usually CT but also MRI) and follow-up appointments in the fracture clinic. All patients enrolled in the pilot should undergo a 4-view plain x-ray 3 months after the initial ED/UCC presentation.

Group Type: ACTIVE_COMPARATOR

X-ray

Intervention Type: PROCEDURE

X-ray exam (conventional radiography)

Interventions

MRI

Magnetic Resonance Imaging Scan

Intervention Type: PROCEDURE

X-ray

X-ray exam (conventional radiography)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients considered to be suitable for the proposed pathway include every patient aged 16 years old or above, presenting at A&E/UCC between 8:00am and 4:00pm (Monday to Friday), with at least one of the following:
• 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 out-stretched hand (FOOSH), wrist injury or poor history associated with examination findings suggestive of scaphoid fracture.

Exclusion Criteria

• Patients presenting outside GSTT's catchment area not willing to be followed-up at GSTT;
• Patients without suspected scaphoid fracture following an initial A&E/UCC clinical triage;
• Patients with scaphoid fracture not admitted through A&E at St Thomas' Hospital or Urgent Care Centre at Guy's Hospital;
• Patients presenting at ED/UCC on weekdays (Monday to Friday) before 8:00am or after 4:00pm
• Patients presenting at ED/UCC on weekends or Bank Holidays;
• 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 products (CTIMPs);
• Patient is unable or unsuitable to MRI

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

sanjay vijayanathan, MRCP FRCR

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas Hospital NHS Foundation

Other Identifiers

RJ115/N294

Identifier Type: -

Identifier Source: org_study_id