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

Scaphoid Fracture Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02605096
• Other study ID #: RJ115/N294
• Status: Terminated
• Phase: Phase 3
• First received: November 5, 2015
• Last updated: August 7, 2017
• Start date: November 1, 2015
• Est. completion date: April 1, 2016

Study information

• Verified date: August 2017
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 1, 2016
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Scaphoid Fracture

Intervention

Procedure:
• MRI
Magnetic Resonance Imaging Scan
• X-ray
X-ray exam (conventional radiography)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Recruitment rate	Number of patients recruited divided by total number of patients eligible and approached	1 month
Primary	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
Primary	Time elapsed (measured in hours and minutes) from A&E presentation to the initial MRI or x-ray investigation.		1 month
Primary	Time elapsed (measured in hours and minutes) from A&E presentation to treatment (either plaster cast or removable splint).		1 month
Primary	Time elapsed (measured in hours and minutes) from A&E presentation to A&E discharge.		1 month
Secondary	Study attrition rate	% patients lost to follow-up	4 months
Secondary	The proportion of patient who completed the EQ-5D-5L 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.	4 months
Secondary	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.	4 months
Secondary	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.	4 months