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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
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).
Time frame: 1 month
Recruitment rate
Number of patients recruited divided by total number of patients eligible and approached
Time frame: 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.
Time frame: 1 month
Time elapsed (measured in hours and minutes) from A&E presentation to the initial MRI or x-ray investigation.
Time frame: 1 month
Time elapsed (measured in hours and minutes) from A&E presentation to treatment (either plaster cast or removable splint).
Time frame: 1 month
Time elapsed (measured in hours and minutes) from A&E presentation to A&E discharge.
Time frame: 1 month
Study attrition rate
% patients lost to follow-up
Time frame: 4 months
The proportion of patient who completed the EQ-5D-5L questionnaire.
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Data collected will be used to inform the main study and will determine if any change in processes is required, prior to commencing main study.
Time frame: 4 months
The proportion of patient who completed the patient resource use diary.
Data collected will be used to inform the main study and will determine if any change in processes is required, prior to commencing main study.
Time frame: 4 months
The proportion of patient who completed the patient experience questionnaire.
Data collected will be used to inform the main study and will determine if any change in processes is required, prior to commencing main study.
Time frame: 4 months