Clinical trial NCT02605096: Pilot Study to Test the Feasibility of the Use of MRI in Suspected Scaphoid Fractures
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Scaphoid Fracture
Keywords: suspected scaphoid fracture
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2015-11-16
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Time elapsed (measured in hours and minutes) from A&E presentation to study recruitment.
timeFrame: 1 month
measure: Recruitment rate
timeFrame: 1 month
measure: The proportion of mandatory fields of the Case Report Form completed including eligibility criteria, medical examination and history, patient demographics, randomisation and documents checklist.
timeFrame: 1 month
measure: Time elapsed (measured in hours and minutes) from A&E presentation to the initial MRI or x-ray investigation.
timeFrame: 1 month
measure: Time elapsed (measured in hours and minutes) from A&E presentation to treatment (either plaster cast or removable splint).
timeFrame: 1 month
measure: Time elapsed (measured in hours and minutes) from A&E presentation to A&E discharge.
timeFrame: 1 month
Secondary outcomes:
measure: Study attrition rate
timeFrame: 4 months
measure: The proportion of patient who completed the EQ-5D-5L questionnaire.
timeFrame: 4 months
measure: The proportion of patient who completed the patient resource use diary.
timeFrame: 4 months
measure: The proportion of patient who completed the patient experience questionnaire.
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Guy's and St Thomas Hospital NHS Foundation
name: sanjay vijayanathan, MRCP FRCR
role: PRINCIPAL_INVESTIGATOR
References: