Scaphoid FracturePhase 3NCT02605096
Pilot Study to Test the Feasibility of the Use of MRI in Suspected Scaphoid Fractures
A Phase 3 study testing MRI and X-ray in people with Scaphoid Fracture, run by Guy's and St Thomas' NHS Foundation Trust.
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. 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?
- MRI and X-ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 1 Apr 2016
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Scaphoid Fracture
- Being tested
- MRI, X-ray
- Keywords
- suspected scaphoid fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Magnetic Resonance Imaging Scan
X-rayProcedure or surgery
X-ray exam (conventional radiography)
| Study group | Role | What they receive |
|---|---|---|
| MRI group | Experimental | 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. Receives: Procedure: MRI |
| X-ray group | Active comparator | 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. Receives: Procedure: X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Recruitment rate
Number of patients recruited divided by total number of patients eligible and approached
Measured: 1 month
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.
Measured: 1 month
Time elapsed (measured in hours and minutes) from A&E presentation to the initial MRI or x-ray investigation.
Measured: 1 month
Time elapsed (measured in hours and minutes) from A&E presentation to treatment (either plaster cast or removable splint).
Measured: 1 month
Time elapsed (measured in hours and minutes) from A&E presentation to A&E discharge.
Measured: 1 month
Secondary outcomes (4)
Study attrition rate
% patients lost to follow-up
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study start1 Nov 2015
- Primary completion1 Apr 2016
- Study completion1 Apr 2016
Why it stopped: Recruitment strategy not working. This information was really useful to design a randomised controlled trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
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
- sanjay vijayanathan, MRCP FRCR, Principal investigator, Guy's and St Thomas Hospital NHS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605096
- Sponsor's protocol ID
- RJ115/N294
- Status last verified
- Aug 2017
- First submitted
- 5 Nov 2015
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
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 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
- ClinicalTrials.gov ID
- NCT02605096
- Acronym / sponsor ID
- RJ115/N294
- Conditions
- Scaphoid Fracture
- Keywords
- suspected scaphoid fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment strategy not working. This information was really useful to design a randomised controlled trial.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 16 Nov 2015 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI group | Experimental | Procedure: MRIThis 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. |
| X-ray group | Active comparator | Procedure: X-rayThis 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| MRIMagnetic Resonance Imaging Scan | Procedure or surgery | MRI group |
| X-rayX-ray exam (conventional radiography) | Procedure or surgery | X-ray group |
Primary outcome
Time elapsed (measured in hours and minutes) from A&E presentation to study recruitment.
Time frame: 1 month
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
Time frame: 1 month
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.
Time frame: 1 month
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 frame: 1 month
Time elapsed (measured in hours and minutes) from A&E presentation to treatment (either plaster cast or removable splint).
Time frame: 1 month
Time elapsed (measured in hours and minutes) from A&E presentation to A&E discharge.
Time frame: 1 month
4 secondary outcomes
Study attrition rate
Time frame: 4 months
The proportion of patient who completed the EQ-5D-5L questionnaire.
Time frame: 4 months
The proportion of patient who completed the patient resource use diary.
Time frame: 4 months
The proportion of patient who completed the patient experience questionnaire.
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Recruitment strategy not working. This information was really useful to design a randomised controlled trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
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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.
sanjay vijayanathan, MRCP FRCR principal investigator
Guy's and St Thomas Hospital NHS Foundation
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRI and X-ray in people with Scaphoid Fracture, run by Guy's and St Thomas' NHS Foundation Trust.
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 3 inclusion and 8 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: stopped early, 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.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment strategy not working. This information was really useful to design a randomised controlled trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time elapsed (measured in hours and minutes) from A&E presentation to study recruitment. (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.