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

NCT02605096 | Terminated Phase 3

• 1 other identifier: RJ115/N294
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Scaphoid Fracture

Keywords

suspected scaphoid fracture

Outcome Measures

Primary Outcomes (6)

• Time elapsed (measured in hours and minutes) from A&E presentation to study recruitment.

  Please note that the submitted study is a pilot to test feasibility of main study. Due to the recruitment of patients from A\&E, informed consent will need to be obtained for the study without negatively impacting clinical care (E.g Delay to treatment of patient with scaphoid fracture).

  1 month

• Recruitment rate

  Number of patients recruited divided by total number of patients eligible and approached

  1 month

• The proportion of mandatory fields of the Case Report Form completed including eligibility criteria, medical examination and history, patient demographics, randomisation and documents checklist.

  This will test the study's data collection procedures.

  1 month

• Time elapsed (measured in hours and minutes) from A&E presentation to the initial MRI or x-ray investigation.

  1 month

• Time elapsed (measured in hours and minutes) from A&E presentation to treatment (either plaster cast or removable splint).

  1 month

• Time elapsed (measured in hours and minutes) from A&E presentation to A&E discharge.

  1 month

Secondary Outcomes (4)

• Study attrition rate

  4 months

• The proportion of patient who completed the EQ-5D-5L questionnaire.

  4 months

• The proportion of patient who completed the patient resource use diary.

  4 months

• The proportion of patient who completed the patient experience questionnaire.

  4 months

Study Arms (2)

MRI group

EXPERIMENTAL

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.

Procedure: MRI

X-ray group

ACTIVE COMPARATOR

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.

Procedure: X-ray

Interventions

MRI PROCEDURE

Magnetic Resonance Imaging Scan

MRI group

X-ray PROCEDURE

X-ray exam (conventional radiography)

X-ray group

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:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• sanjay vijayanathan, MRCP FRCR

  Guy's and St Thomas Hospital NHS Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 16, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 8, 2017

Record last verified: 2017-08