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

Primary Purpose

Scaphoid Fracture

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MRI
X-ray
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Scaphoid Fracture focused on measuring suspected scaphoid fracture

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MRI group

    X-ray group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).
    Recruitment rate
    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.
    This will test the study's data collection procedures.
    Time elapsed (measured in hours and minutes) from A&E presentation to the initial MRI or x-ray investigation.
    Time elapsed (measured in hours and minutes) from A&E presentation to treatment (either plaster cast or removable splint).
    Time elapsed (measured in hours and minutes) from A&E presentation to A&E discharge.

    Secondary Outcome Measures

    Study attrition rate
    % patients lost to follow-up
    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.
    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.
    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.

    Full Information

    First Posted
    November 5, 2015
    Last Updated
    August 7, 2017
    Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    King's College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02605096
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Recruitment strategy not working. This information was really useful to design a randomised controlled trial.
    Study Start Date
    November 1, 2015 (Actual)
    Primary Completion Date
    April 1, 2016 (Actual)
    Study Completion Date
    April 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    King's College London

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Scaphoid Fracture
    Keywords
    suspected scaphoid fracture

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MRI group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    X-ray group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    MRI
    Intervention Description
    Magnetic Resonance Imaging Scan
    Intervention Type
    Procedure
    Intervention Name(s)
    X-ray
    Intervention Description
    X-ray exam (conventional radiography)
    Primary Outcome Measure Information:
    Title
    Time elapsed (measured in hours and minutes) from A&E presentation to study recruitment.
    Description
    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
    Title
    Recruitment rate
    Description
    Number of patients recruited divided by total number of patients eligible and approached
    Time Frame
    1 month
    Title
    The proportion of mandatory fields of the Case Report Form completed including eligibility criteria, medical examination and history, patient demographics, randomisation and documents checklist.
    Description
    This will test the study's data collection procedures.
    Time Frame
    1 month
    Title
    Time elapsed (measured in hours and minutes) from A&E presentation to the initial MRI or x-ray investigation.
    Time Frame
    1 month
    Title
    Time elapsed (measured in hours and minutes) from A&E presentation to treatment (either plaster cast or removable splint).
    Time Frame
    1 month
    Title
    Time elapsed (measured in hours and minutes) from A&E presentation to A&E discharge.
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Study attrition rate
    Description
    % patients lost to follow-up
    Time Frame
    4 months
    Title
    The proportion of patient who completed the EQ-5D-5L questionnaire.
    Description
    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
    Title
    The proportion of patient who completed the patient resource use diary.
    Description
    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
    Title
    The proportion of patient who completed the patient experience questionnaire.
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    sanjay vijayanathan, MRCP FRCR
    Organizational Affiliation
    Guy's and St Thomas Hospital NHS Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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