Back to resultsThe Use of MRI in the Assessment of Suspected Scaphoid Fracture With Negative Findings on the Initial Plain Radiography (SMRI)
Primary Purpose
Scaphoid Fracture
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Wrist Magnetic Resonance Imaging (MRI)
Sponsored by
About this trial
This is an interventional diagnostic trial for Scaphoid Fracture
Eligibility Criteria
Inclusion Criteria:
Every patient aged 16 years or over presenting at A&E/UCC with clinical history and examination consistent with a suspected scaphoid fracture but negative findings on the initial 4-view plain x-ray. It is considered that a patient has suspected scaphoid fracture if at least one of the following criteria are present:
- 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 an out-stretched hand (FOOSH), wrist injury or poor history associated with examination findings suggestive of scaphoid fracture.
Furthermore, only patients that present at A&E/UCC during the following schedule of MRI normal working hours will be included in the study:
- Patients screened for the study at A&E/UCC on weekdays after 7.30 am and before 6 pm;
- Patients screened for the study at A&E/UCC on weekends or Bank Holidays after 9 am and before 4 pm.
Exclusion Criteria:
- Patients presenting outside GSTT's catchment area who are not willing to be followed-up at GSTT;
- Patients with a confirmed scaphoid fracture following the initial 4-view plain x-ray;
- Patients with confirmed ipsilateral upper limb injury/injuries (e.g. wrist/forearm/arm injury) following initial conventional x-ray examination(s) - regardless of the findings around the suspected scaphoid fracture.
- Patients with suspected scaphoid fracture not admitted through A&E at St Thomas' Hospital or Urgent Care Centre (UCC) at Guy's Hospital;
- 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 Product (CTIMP);
- Prisoners.
Sites / Locations
- Guy's and St Thomas' NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No further imaging
Wrist Magnetic Resonance Imaging (MRI)
Arm Description
Patients randomised to this group will receive standard care, i.e. will not undergo additional imaging scans at A&E/Urgent Care Centre.
Patients randomised to this group will undergo an additional 3-sequence wrist MRI during the initial A&E/Urgent Care Centre episode.
Outcomes
Primary Outcome Measures
3-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode
The primary objective is to estimate the 3-month costs associated with two clinical pathways at A&E/UCC: (i) the current pathway, with x-ray as the only imaging modality (no further imaging group); or (ii) the proposed pathway (MRI group), with a hybrid approach i.e. using x-ray as the initial imaging modality and subsequently MRI for patients with negative findings on the initial x-ray.
Secondary Outcome Measures
6-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode
This objective aims to estimate the 6-month costs associated with two clinical pathways at A&E/UCC: (i) the current pathway, with x-ray as the only imaging modality (no further imaging group); or (ii) the proposed pathway (MRI group), with a hybrid approach i.e. using x-ray as the initial imaging modality and subsequently MRI for patients with negative findings on the initial x-ray.
3-month cost-effectiveness analysis (ICER measured as £ per QALY) following the A&E/UCC initial episode
A cost-effectiveness analysis takes into account both the costs and outcomes related to the interventions. An unique incremental cost-effectiveness ratio (ICER), measured as £ per QALY, will be estimated comparing both interventions at 3 months.
6-month cost-effectiveness analysis (ICER measured as £ per QALY) following the A&E/UCC initial episode
A cost-effectiveness analysis takes into account both the costs and outcomes related to the interventions. An unique incremental cost-effectiveness ratio (ICER), measured as £ per QALY, will be estimated comparing both interventions at 6 months.
Cost per correctly diagnosed scaphoid fracture (measured in £ per correct diagnosis)
The cost per correctly diagnosed scaphoid fracture with the proposed intervention compared to standard care will be considered to evaluate whether overall potential cost-savings are aligned with the benefits of an improved diagnostic pathway.
Findings from the treatment group (with MRI) and the control group (no further imaging) will be compared against the 3-month 4-view plain x-ray (gold standard). If both imaging findings are consistent, it is considered that a correct diagnosis was achieved.
Patient satisfaction in both groups (to be assessed using non-standard questionnaires, based on a 1-5 likert scale)
Patient experience will be evaluated using patient questionnaires. The underlying hypothesis is that the use of MRI will promote an improvement in the patient's overall experience, due to: i) a decrease in the need for secondary care contacts; ii) the reduction of plaster casts utilisation; and (iii) an improved and definitive diagnosis and subsequent treatment.
Likelihood ratio of the proposed pathway (i.e. wrist MRI group) in the detection of scaphoid fracture compared to the current pathway (no further imaging group)
The overall likelihood ratio and diagnostic accuracy (sensitivity and specificity) of the MRI for the early identification of scaphoid fractures in the proposed pathway will be assessed against a 3-month conventional 4-view plain x-ray as the comparator.
Time (measured in days) taken to reach a definitive diagnosis and the first major treatment decision based on the MRI in comparison to the current pathway
The study will evaluate the time required to achieve a definitive diagnosis and deliver the subsequent appropriate treatment. It is considered that a definitive diagnosis is reached once there is agreement between the initial (at A&E/UCC) and/or the follow-up (at fracture clinic) imaging exams and the final 3-month plain x-ray.
Percentage of agreement between radiographers and radiologists in the diagnosis of suspected scaphoid fractures
The percentage of agreement between radiographers and radiologists in the diagnosis of suspected scaphoid fractures (i.e. rule in/rule out) using MRI datasets will also be assessed. This information will provide pivotal insight as to how the proposed clinical pathway can operationally be rolled out, as well as future areas of research.
Time off work or informal care needs (measured in days) due to the suspected scaphoid fracture.
The study aims to assess potential benefits from a broader societal perspective. For this purpose, time off work and informal care required due to the suspected scaphoid fracture will be recorded. The underlying hypothesis is that the use of MRI might reduce the amount of unnecessary plaster casts (i.e. in patients with no scaphoid fracture) and translate into a reduction in days off work and subsequent need for informal care.
Full Information
NCT ID
NCT02801149
First Posted
June 3, 2016
Last Updated
August 7, 2017
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT02801149
Brief Title
The Use of MRI in the Assessment of Suspected Scaphoid Fracture With Negative Findings on the Initial Plain Radiography
Acronym
SMRI
Official Title
A Single Centre Randomised, Non-blinded, Prospective Study to Evaluate the Use of MRI for Patients Presenting With Suspected Scaphoid Fracture With Negative Findings on the Initial Conventional Radiography
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2016 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
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
Yes
5. Study Description
Brief Summary
Given that: 1) various clinical complications may arise from a misdiagnosed scaphoid fracture; and 2) clinical and radiographic diagnosis of scaphoid fracture is often challenging, particularly at the time of presentation, this study aims to evaluate whether the use of Magnetic Resonance Imaging (MRI) in the investigation of patients presenting with a suspected scaphoid fracture, with negative findings from the initial conventional radiography (4-view plain x-ray), leads to improved levels of efficiency, quality of care and patient experience.
This study is a single centre randomised, non-blinded, prospective study. Participants will be randomised, following the initial negative conventional radiography, to either: no further imaging at A&E (consistent with current clinical practice); or 2) wrist MRI. The study considers a follow-up period of 6 months.
Detailed Description
The scaphoid bone is an obliquely orientated bone on the radial (thumb) side of the wrist, between the distal carpal row and the radius. Wrist injury is a common presentation to the Emergency Department (ED) in the UK. Amongst these patients, the scaphoid is the most commonly fractured carpal bone, accounting for 51-90% of carpal fractures and between 2-7% of all fractures.
Given that: 1) various clinical complications may arise from a misdiagnosed scaphoid fracture; and 2) clinical and radiographic diagnosis of scaphoid fracture is often challenging, particularly at the time of presentation, this study aims to evaluate whether the use of Magnetic Resonance Imaging (MRI) in the investigation of patients presenting with a suspected scaphoid fracture, with negative findings from the initial conventional radiography (4-view plain x-ray), leads to improved levels of efficiency, quality of care and patient experience.
This study is a single centre randomised, non-blinded, prospective study. Participants will be randomised, following the initial negative conventional radiography, to either: no further imaging at A&E (consistent with current clinical practice); or 2) wrist MRI. The study considers a follow-up period of 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scaphoid Fracture
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No further imaging
Arm Type
No Intervention
Arm Description
Patients randomised to this group will receive standard care, i.e. will not undergo additional imaging scans at A&E/Urgent Care Centre.
Arm Title
Wrist Magnetic Resonance Imaging (MRI)
Arm Type
Experimental
Arm Description
Patients randomised to this group will undergo an additional 3-sequence wrist MRI during the initial A&E/Urgent Care Centre episode.
Intervention Type
Procedure
Intervention Name(s)
Wrist Magnetic Resonance Imaging (MRI)
Intervention Description
Patients that enter this group are randomised to receive non-standard care with a 3-sequence MRI scan of the scaphoid following the initial conventional radiography.
Primary Outcome Measure Information:
Title
3-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode
Description
The primary objective is to estimate the 3-month costs associated with two clinical pathways at A&E/UCC: (i) the current pathway, with x-ray as the only imaging modality (no further imaging group); or (ii) the proposed pathway (MRI group), with a hybrid approach i.e. using x-ray as the initial imaging modality and subsequently MRI for patients with negative findings on the initial x-ray.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
6-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode
Description
This objective aims to estimate the 6-month costs associated with two clinical pathways at A&E/UCC: (i) the current pathway, with x-ray as the only imaging modality (no further imaging group); or (ii) the proposed pathway (MRI group), with a hybrid approach i.e. using x-ray as the initial imaging modality and subsequently MRI for patients with negative findings on the initial x-ray.
Time Frame
6 months
Title
3-month cost-effectiveness analysis (ICER measured as £ per QALY) following the A&E/UCC initial episode
Description
A cost-effectiveness analysis takes into account both the costs and outcomes related to the interventions. An unique incremental cost-effectiveness ratio (ICER), measured as £ per QALY, will be estimated comparing both interventions at 3 months.
Time Frame
3 months
Title
6-month cost-effectiveness analysis (ICER measured as £ per QALY) following the A&E/UCC initial episode
Description
A cost-effectiveness analysis takes into account both the costs and outcomes related to the interventions. An unique incremental cost-effectiveness ratio (ICER), measured as £ per QALY, will be estimated comparing both interventions at 6 months.
Time Frame
6 months
Title
Cost per correctly diagnosed scaphoid fracture (measured in £ per correct diagnosis)
Description
The cost per correctly diagnosed scaphoid fracture with the proposed intervention compared to standard care will be considered to evaluate whether overall potential cost-savings are aligned with the benefits of an improved diagnostic pathway.
Findings from the treatment group (with MRI) and the control group (no further imaging) will be compared against the 3-month 4-view plain x-ray (gold standard). If both imaging findings are consistent, it is considered that a correct diagnosis was achieved.
Time Frame
3 months
Title
Patient satisfaction in both groups (to be assessed using non-standard questionnaires, based on a 1-5 likert scale)
Description
Patient experience will be evaluated using patient questionnaires. The underlying hypothesis is that the use of MRI will promote an improvement in the patient's overall experience, due to: i) a decrease in the need for secondary care contacts; ii) the reduction of plaster casts utilisation; and (iii) an improved and definitive diagnosis and subsequent treatment.
Time Frame
3 months
Title
Likelihood ratio of the proposed pathway (i.e. wrist MRI group) in the detection of scaphoid fracture compared to the current pathway (no further imaging group)
Description
The overall likelihood ratio and diagnostic accuracy (sensitivity and specificity) of the MRI for the early identification of scaphoid fractures in the proposed pathway will be assessed against a 3-month conventional 4-view plain x-ray as the comparator.
Time Frame
3 months
Title
Time (measured in days) taken to reach a definitive diagnosis and the first major treatment decision based on the MRI in comparison to the current pathway
Description
The study will evaluate the time required to achieve a definitive diagnosis and deliver the subsequent appropriate treatment. It is considered that a definitive diagnosis is reached once there is agreement between the initial (at A&E/UCC) and/or the follow-up (at fracture clinic) imaging exams and the final 3-month plain x-ray.
Time Frame
3 months
Title
Percentage of agreement between radiographers and radiologists in the diagnosis of suspected scaphoid fractures
Description
The percentage of agreement between radiographers and radiologists in the diagnosis of suspected scaphoid fractures (i.e. rule in/rule out) using MRI datasets will also be assessed. This information will provide pivotal insight as to how the proposed clinical pathway can operationally be rolled out, as well as future areas of research.
Time Frame
1 week
Title
Time off work or informal care needs (measured in days) due to the suspected scaphoid fracture.
Description
The study aims to assess potential benefits from a broader societal perspective. For this purpose, time off work and informal care required due to the suspected scaphoid fracture will be recorded. The underlying hypothesis is that the use of MRI might reduce the amount of unnecessary plaster casts (i.e. in patients with no scaphoid fracture) and translate into a reduction in days off work and subsequent need for informal care.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Every patient aged 16 years or over presenting at A&E/UCC with clinical history and examination consistent with a suspected scaphoid fracture but negative findings on the initial 4-view plain x-ray. It is considered that a patient has suspected scaphoid fracture if at least one of the following criteria are present:
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 an out-stretched hand (FOOSH), wrist injury or poor history associated with examination findings suggestive of scaphoid fracture.
Furthermore, only patients that present at A&E/UCC during the following schedule of MRI normal working hours will be included in the study:
Patients screened for the study at A&E/UCC on weekdays after 7.30 am and before 6 pm;
Patients screened for the study at A&E/UCC on weekends or Bank Holidays after 9 am and before 4 pm.
Exclusion Criteria:
Patients presenting outside GSTT's catchment area who are not willing to be followed-up at GSTT;
Patients with a confirmed scaphoid fracture following the initial 4-view plain x-ray;
Patients with confirmed ipsilateral upper limb injury/injuries (e.g. wrist/forearm/arm injury) following initial conventional x-ray examination(s) - regardless of the findings around the suspected scaphoid fracture.
Patients with suspected scaphoid fracture not admitted through A&E at St Thomas' Hospital or Urgent Care Centre (UCC) at Guy's Hospital;
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 Product (CTIMP);
Prisoners.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bharti Malhotra, MSc
Email
bharti.malhotra@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Tiago Rua, MSc
Email
tiago.rua@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Gidwani
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bharti Malhotra
First Name & Middle Initial & Last Name & Degree
Tiago Rua
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29366329
Citation
Rua T, Vijayanathan S, Parkin D, Goh V, McCrone P, Gidwani S. Rationale and design of the SMaRT trial: A randomised, prospective, parallel, non-blinded, one-centre trial to evaluate the use of magnetic resonance imaging in acute setting in patients presenting with suspected scaphoid fracture. Clin Trials. 2018 Apr;15(2):120-129. doi: 10.1177/1740774517748320. Epub 2018 Jan 24.
Results Reference
derived
Learn more about this trial
The Use of MRI in the Assessment of Suspected Scaphoid Fracture With Negative Findings on the Initial Plain Radiography
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