Scaphoid FractureSMRINCT02801149
The Use of MRI in the Assessment of Suspected Scaphoid Fracture With Negative Findings on the Initial Plain Radiography
A study testing Wrist Magnetic Resonance Imaging (MRI) in people with Scaphoid Fracture, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Scaphoid Fracture
- What is being tested?
- Wrist Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Bharti Malhotra, MSc contact
Tiago Rua, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Bharti Malhotra
Tiago Rua
About this study
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
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.
Read the 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.
- Conditions
- Scaphoid Fracture
- Being tested
- Wrist Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist Magnetic Resonance Imaging (MRI)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| No further imaging | No intervention | Patients randomised to this group will receive standard care, i.e. will not undergo additional imaging scans at A\&E/Urgent Care Centre. |
| Wrist Magnetic Resonance Imaging (MRI) | Experimental | Patients randomised to this group will undergo an additional 3-sequence wrist MRI during the initial A\&E/Urgent Care Centre episode. Receives: Procedure: Wrist Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (9)
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.
Measured: 6 months
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.
Measured: 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.
Measured: 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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 1 week
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start6 Jun 2016
- Primary completionApr 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scaphoid FractureStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Sam Gidwani, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801149
- Sponsor's protocol ID
- Scaphoid MRI
- Acronym
- SMRI
- Status last verified
- Aug 2017
- First submitted
- 3 Jun 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29366329
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02801149
- Acronym / sponsor ID
- SMRI / Scaphoid MRI
- Conditions
- Scaphoid Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No further imaging | No intervention | –Patients randomised to this group will receive standard care, i.e. will not undergo additional imaging scans at A\&E/Urgent Care Centre. |
| Wrist Magnetic Resonance Imaging (MRI) | Experimental | Procedure: Wrist Magnetic Resonance Imaging (MRI)Patients randomised to this group will undergo an additional 3-sequence wrist MRI during the initial A\&E/Urgent Care Centre episode. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist Magnetic Resonance Imaging (MRI)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. | Procedure or surgery | Wrist Magnetic Resonance Imaging (MRI) |
Primary outcome
3-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode
Time frame: 3 months
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.
9 secondary outcomes
6-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode
Time frame: 6 months
3-month cost-effectiveness analysis (ICER measured as £ per QALY) following the A&E/UCC initial episode
Time frame: 3 months
6-month cost-effectiveness analysis (ICER measured as £ per QALY) following the A&E/UCC initial episode
Time frame: 6 months
Cost per correctly diagnosed scaphoid fracture (measured in £ per correct diagnosis)
Time frame: 3 months
Patient satisfaction in both groups (to be assessed using non-standard questionnaires, based on a 1-5 likert scale)
Time frame: 3 months
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)
Time frame: 3 months
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
Time frame: 3 months
Percentage of agreement between radiographers and radiologists in the diagnosis of suspected scaphoid fractures
Time frame: 1 week
Time off work or informal care needs (measured in days) due to the suspected scaphoid fracture.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Derived from this study: PubMed 29366329Rua 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bharti Malhotra, MSc contact
Tiago Rua, MSc contact
Sam Gidwani principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist Magnetic Resonance Imaging (MRI) in people with Scaphoid Fracture, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bharti Malhotra, MSc (bharti.malhotra@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month costs (measured in £ per patient) associated with the two clinical groups following the A&E/UCC initial episode (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02801149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.