Exploring the use of extremity cone beam computed tomography (CBCT) technology in the emergency department (ED) for patients with suspected scaphoid fracture
| ISRCTN | ISRCTN12548470 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12548470 |
| IRAS number | 274018 |
| Secondary identifying numbers | 1.2 24/02/2020, IRAS 274018 |
- Submission date
- 02/03/2020
- Registration date
- 20/04/2020
- Last edited
- 30/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
The scaphoid is a small bone in the wrist commonly broken during falls. Unfortunately, many fractures are not visible on initial x-rays and there can be a delay before the fracture is identified during which the patient must be immobilised and repeatedly visit hospital. X-rays have poor predictive value for scaphoid fractures and other imaging tests such as MRI and CT can be used. However, practice varies across the UK and serial x-rays continue to be the standard diagnostic protocol for imaging. The Mid Yorkshire Hospitals NHS Trust has recently revised the scaphoid fracture pathway to incorporate new extremity Cone Beam Computed Tomography (CBCT) technology. This study aims to find out if the implementation of extremity CBCT in this context enables earlier diagnosis and increased efficiency for both patients and the hospital services.
Who can participate?
All patients over 18 years of age who present at the Emergency Department with a wrist injury and have a suspected scaphoid fracture can participate. Participants must have a positive clinical examination, no other significant injuries, be able to provide informed consent and adhere to questionnaire completion.
What does the study involve?
Participants are consenting to the recording of routinely collected information and their emergency department visit and imaging investigations for the scaphoid injury collected from standard hospital systems. They are asked to complete a questionnaire at baseline about the pain and function before and after the injury. If the initial four-view scaphoid x-ray is normal, they will have an extremity cone beam CT scan of the wrist for further evaluation. If this scan is also normal, a member of the research team will contact them after two weeks (in line with standard follow up) and again at 6 weeks to see if they have recovered as expected. During these telephone calls, many of the same questions asked at baseline will be repeated.
What are the possible benefits and risks of participating?
There are no expected risks from taking part in the study as the x-ray and CT wrist scan are delivered as part of routine care. If taking part in the study, participants you will not undergo any additional imaging procedures to normal. These procedures use ionising radiation to form images of the body and provide clinicians with clinical information. Ionising radiation can cause cell damage that may, after many years or decades turn cancerous. The chances of this happening to are the same whether participating in this study or not.
Follow up telephone calls will be kept as short as possible and we will work with participants to perform them at a time that is convenient. There are no advantages to taking part in the study but being part of the research will provide reassurance in ongoing management of the injury and will allow participants to alert the clinical team of any on-going symptoms. If there are ongoing problems, we will arrange review in a hospital clinic. The information we get from the study will help us improve care of patients with similar injuries in the future and provide valuable information on the use of NHS resources.
Where is the study run from?
Pinderfields Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2020 to August 2020
Who is funding the study?
Carestream Health (USA)
Who is the main contact?
Martine Harris
martine.harris@nhs.net
Prof. Bev Snaith
beverly.snaith@nhs.net
Contact information
Scientific
Radiology Research Team
The Mid Yorkshire Hospitals NHS Trust
Unit 10, Clarke Hall Farm
Aberford Road
Wakefield
WF1 4AL
United Kingdom
 ORCID ID |
0000-0003-1924-3718 |
|---|---|
| Phone | +44 (0)1924 542297 |
| martine.harris@nhs.net |
Scientific
The Mid Yorkshire Hospitals NHS Trust
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
| ORCID ID |
0000-0002-6296-0889 |
|---|---|
| Phone | +44 (0)1924 542034 |
| beverly.snaith@nhs.net |
Study information
| Study design | Single-centre observational |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Improving the Scaphoid Pathway with Extremity CT in the ED: The InSPECTED Study |
| Study acronym | InSPECTED |
| Study objectives | Early access to cross-sectional imaging through the utilisation of Cone Beam Computed Tomography (CBCT) could streamline the imaging and management pathway for patients with suspected scaphoid fractures. |
| Ethics approval(s) | Approved 25/02/2020, The Leicester Central Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8388; leicestercentral.rec@hra.nhs.uk), ref: 20/EM/0012 |
| Health condition(s) or problem(s) studied | Suspected scaphoid fracture |
| Intervention | All participants will be identified as part of their Emergency Department (ED) attendance for wrist injury, and formally consented for participation in the study. Following clinical assessment by an ED Doctor or Emergency Nurse Practitioner (ENP) and completion of a scaphoid screening tool in standard use at the host site, participants with a suspected scaphoid fracture will be referred for four-view scaphoid x-ray. Where this x-ray is normal further diagnostic evaluation by CBCT scan will be performed. This is standard clinical practice at the host site. Research participants with a normal CBCT scan will be followed up at 2-weeks and 6-weeks with telephone interviews, similar to current virtual clinics. Questions relate to their wrist pain and function as well as validated quality of life assessment. At these data collection time points, patients who meet specific criteria regarding ongoing symptoms (increased PROMs score or analgesia use) will be reviewed in a (physical) specialist musculoskeletal ED clinic with appropriate further imaging investigations or alternatively may be referred for physiotherapy if the symptoms persist. Those who consent to participation in the study are also agreeing to the collection of routine hospital data accumulated during their ED attendances related to the injury. This prospective cohort will be compared to a retrospective sample of patients utilising the same criteria and timeframe during the preceding year. |
| Intervention type | Other |
| Primary outcome measure | Number of hospital attendances related to the suspected scaphoid fracture measured at the end of the study using patient records. |
| Secondary outcome measures | Measured using patient records unless otherwise indicated: 1. Number of patients presenting at ED with suspected scaphoid fracture* at baseline 2. Number of patients diagnosed with scaphoid fracture on imaging (prevalence)* at baseline 3. Number and type of imaging investigations (x-rays, CBCT, CT and MRI scans)* at baseline 4. Pathway timings* at baseline 5. Unplanned returns to the ED* at 2 weeks and 6 weeks 6. Planned recalls to the ED* at 2 weeks and 6 weeks 7. ED discharge and referral rates* at baseline 8. CBCT failure rates/delays (patient, technical, staff) at baseline 9. Patient demographics* at baseline 10. Injury demographics including time of presentation, clinical symptoms, injury mechanism and fracture type (if appropriate)* at baseline 11. Patient reported outcome measures (from CRF) at 2 weeks and 6 weeks 11.1. Patient-Rated Wrist Evaluation (PRWE) 11.2. Health Economics/Quality of Life outcomes (EQ-5D-5L) 12. Healthcare resource use at 2 weeks and 6 weeks 13. Radiation dose associated with scaphoid fracture diagnosis / exclusion* at baseline 14. Recruitment rate (assumed consent) 15. Patient baseline CRF (EQ5D-5L and PRWE) completion rates at baseline The data marked with * will also be collected for the retrospective cohort |
| Overall study start date | 20/02/2020 |
| Completion date | 28/08/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 260 |
| Total final enrolment | 68 |
| Key inclusion criteria | 1. Present at any of the EDs across the Trust with a mechanism of injury consistent with scaphoid trauma and a positive clinical examination 2. Over the age of 18 and able to provide informed consent |
| Key exclusion criteria | 1. Do not present via the ED 2. Have an additional injury, which may affect the primary outcome measure 3. Evidence that the patient would be unable to adhere to study or procedures or complete questionnaires, for example has cognitive impairment |
| Date of first enrolment | 04/03/2020 |
| Date of final enrolment | 30/06/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Research Team
Unit 10, Clarke Hall Farm
Aberford Road
Wakefield
WF1 4AL
England
United Kingdom
| Phone | +44 (0)1924 543772 |
|---|---|
| Judith.holliday@nhs.net | |
| Website | https://www.midyorks.nhs.uk/ |
"ROR" |
https://ror.org/05g23q746 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Carestream Health Inc., Carestream Health Incorporated
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal and at international conference. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v1.2 | 24/02/2020 | 20/04/2020 | No | No |
| Results article | 18/11/2021 | 30/11/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN12548470_PROTOCOL_v1.2_24Feb20.pdf
- Uploaded 20/04/2020
Editorial Notes
30/11/2021: Publication reference added.
27/08/2020: The intention to publish date was changed from 30/09/2020 to 30/11/2020. Total final enrolment number added.
01/07/2020: The recruitment end date was changed from 31/03/2020 to 30/06/2020.
20/04/2020: Uploaded protocol Version 1.2, 24 February 2020 (not peer reviewed).
04/03/2020: Trial’s existence confirmed by Leicester Central Research Ethics Committee.
