A Single Centre Randomised, Non-blinded, Prospective Pilot to Test the Feasibility Associated With the Use of MRI as the Initial Imaging Modality in the Investigation of Patients Presenting With Suspected Scaphoid Fracture
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Scaphoid Fracture
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Enrollment
- 10
- Primary Endpoint
- Time elapsed (measured in hours and minutes) from A&E presentation to the initial MRI or x-ray investigation.
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
Time elapsed (measured in hours and minutes) from A&E presentation to study recruitment.
Time Frame: 1 month
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).
Recruitment rate
Time Frame: 1 month
Number of patients recruited divided by total number of patients eligible and approached
The proportion of mandatory fields of the Case Report Form completed including eligibility criteria, medical examination and history, patient demographics, randomisation and documents checklist.
Time Frame: 1 month
This will test the study's data collection procedures.
Secondary Outcomes
- 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)