Ankle fracture imaging of patients with a complex injury
| ISRCTN | ISRCTN25963775 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25963775 |
| IRAS number | 323665 |
| Secondary identifying numbers | IRAS 323665, CPMS 62762 |
- Submission date
- 16/05/2024
- Registration date
- 20/08/2024
- Last edited
- 28/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Every day in the UK around 170 people have an ankle fracture, and the numbers are increasing by about 10% each year. A complex ankle fracture involves a break of two, or more, bones and usually requires an operation. Everyone has an X-ray of their ankle if they have a fracture, but some surgeons will also want a Computed Tomography (CT) scan to show more cross sectional detail of the injury. Although there is some evidence that a CT scan can help in making treatment decisions, no research has examined how quickly this should occur and it is unclear whether this delays treatment. We want to find out if doing an early CT scan could speed up treatment decisions and improve recovery (outcomes).
This small research project, which aims to recruit a minimum of 60 patients in a single hospital Trust, will help us to work out if it is feasible to do a larger project across multiple hospitals in the future. The primary aim at this stage is therefore to establish the criteria required (patient outcomes, population, recruitment) for a larger trial.
Who can participate?
Adult patients aged 16 years and older, attending the emergency department or urgent treatment centre with a radiographically confirmed unstable or complex ankle fracture. Participants are eligible if the trial intervention (early CT scan) can be provided within 24 hours of presentation at hospital. They must have no other significant injuries or complications, be able to provide consent and adhere to questionnaire completion.
What does the study involve?
Participants are consenting to the recording of routinely collected information about their emergency department visit, imaging investigations and definitive treatment. A questionnaire at baseline will establish their pain and mobility before and after the injury.
Participants will be randomly allocated to a control group or intervention group so that there is at least 30 people in each group. The imaging tests carried out in the control group (post initial diagnosis with X-ray) will be at the discretion of the consultant orthopaedic surgeon, this may include a CT scan for pre-treatment planning. Those in the intervention group will be booked for a CT scan on the same or next day as part of an early cross-sectional imaging strategy. The treatment and clinical follow up of all participants will be in line with the usual care provided by the Trust.
After discharge from hospital, participants will be followed up for 6 months after the injury using questionnaires to map measures for ankle function and quality of life, as well as NHS resource use and complications. A small sub-set of participants in both groups will contribute to qualitative interviews around the lived experience of their injury, the imaging tests performed and participation in the research.
What are the possible benefits and risks of participating?
There are no direct benefits from taking part in the study, but the results will help to ensure that those who injure their ankle after the study is completed will have a clear imaging pathway for fracture diagnosis and treatment planning.
There are no expected risks from taking part in this study if allocated to the control group as all imaging examinations are standard care. Those in the interventional group will all have a CT scan, that may, or may not have been obtained if not participating in the study. There is an extremely small risk associated with this radiation burden which will be explained as part of the study consent procedure.
Follow up telephone calls to complete questionnaires will be kept as short as possible and conducted at a convenient time.
Where is the study run from?
The Mid Yorkshire Teaching NHS Trust, Pinderfields Hospital, UK.
When is the study starting and how long is it expected to run for?
March 2024 to July 2025
Who is funding the study?
The College of Radiographers Industry Partnership Scheme (CoRIPS award 202) (UK)
Who is the main contact?
Martine Mallinson, PhD; Chief Investigator & Lead Research Radiographer, martine.harris@nhs.net
Contact information
Public, Scientific, Principal Investigator
Mid Yorkshire Teaching NHS Trust
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
 ORCID ID |
0000-0003-1924-3718 |
|---|---|
| Phone | +44 (0)1924 543070 |
| martine.harris@nhs.net |
Study information
| Study design | Single-centre feasibility randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Ankle fracture imaging: a feasibility randomised controlled trial examining the impact of early CT on outcomes of patients with a complex injury |
| Study acronym | ALIGN |
| Study objectives | The British Orthopaedic Association (BOA) recommend that surgery for a complex ankle fracture should be performed within 24 hours. A growing evidence base suggests that CT scans provide additional clinical information for treatment planning. However, research is required to confirm if early CT scanning is valuable and results in improved outcomes for patients. |
| Ethics approval(s) |
Approved 08/10/2024, Yorkshire & The Humber- South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre , Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8021; southyorks.rec@hra.nhs.uk), ref: 24/YH/0190 |
| Health condition(s) or problem(s) studied | Complex and/or unstable ankle fracture |
| Intervention | Participants with a radiographically confirmed complex ankle fracture will be allocated 1:1 to a standard care arm where any imaging will be performed at the discretion of the Consultant Orthopaedic Surgeon, or to an intervention arm where a CT scan will performed on all participants on day 0-1 after the injury. Participants will be randomised using the online web service sealedenvelope.com. |
| Intervention type | Other |
| Primary outcome measure | Ankle symptoms measured using the Olerud- Molander Ankle Score (OMAS) at 6 months after the injury |
| Secondary outcome measures | 1. Ankle symptoms measured using the Olerud- Molander Ankle Score (OMAS) at 6 weeks, 3 months and 6 months after the injury 2. Health related quality of life measured using the EQ-5D-5L questionnaire at 6 weeks, 3 months and 6 months after the injury 3. Healthcare resource use measured using patient questionnaire and routine hospital attendance data of planned and unplanned visits to hospital at study allocation, 6 weeks, 3 months and 6 months after the injury 4. Feasibility measured using screening and recruitment logs, and change of status forms (Withdrawals, loss to follow up) at study close out 5. Patient experience measured using semi structured qualitative interviews to explore the lived experience of a sub-set of participants in both study arms at 6 weeks and 6 months post allocation |
| Overall study start date | 04/03/2024 |
| Completion date | 27/02/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Adult patients aged 16 years and over 2. Radiographic evidence of a complex and/or unstable ankle fracture 3. The trial intervention (CT scan) can be provided within 24 hours of presentation 4. Able to provide informed consent |
| Key exclusion criteria | 1. The injury is more than 24 hours old 2. The patient is younger than 16 years old or they are pregnant 3. There are bilateral or additional fractures, or involvement of other body systems where treatment and rehabilitation would vary from normal expected procedures, and outcomes for the trial may be affected 4. Cases of open fracture with severe soft tissue compromise giving rise to additional complications affecting trial outcomes 5. Definitive emergent treatment has occurred or has been initiated 6. The patient would be unable to adhere to trial procedures or complete questionnaires |
| Date of first enrolment | 22/07/2024 |
| Date of final enrolment | 29/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Sponsor information
Hospital/treatment centre
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
England
United Kingdom
| Phone | +44 (0)1924 543319 |
|---|---|
| Alex.clarkson1@nhs.net | |
| Website | http://www.midyorks.nhs.uk/ |
"ROR" |
https://ror.org/05g23q746 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- CoR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/08/2026 |
|---|---|
| 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 | The findings will be shared through traditional and novel methods. Traditional dissemination of key outputs with the academic and clinical community will be through an international conference presentation and a professional peer-review publication, focussing on stakeholders including radiology, emergency medicine and trauma and orthopaedics. Links will be developed with key organisations such as the British Orthopaedic Association and NICE as the outcomes will be of interest to these bodies and their networks. Open access is not being considered within the dissemination of this small-scale feasibility study but will be for a future prospective multicentre RCT exploring the wider impact of CT within the ankle fracture pathway. Study participants will be consented to receive a summary of the research outcomes. With support from the local NHS communications team, the results of the study will be shared with patients, the public and staff through a plain English summary and infographic. To ensure that the results are accessible to a wide audience, professional and public dissemination will also include a range of social media reporting including X (formerly known as Twitter) and other relevant charities, patient associations and blogs. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
28/01/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 31/01/2025 to 29/08/2025.
2. The overall study end date was changed from 31/07/2025 to 27/02/2026.
3. The intention to publish date was changed from 31/07/2026 to 28/08/2026.
18/10/2024: Ethics approval added.
10/09/2024: Internal review.
24/06/2024: Trial's existence confirmed by The College of Radiographers.
