AnkLe fracture ImaGiNg: The impact of early CT in complex injuries. V1
Research type
Research Study
Full title
AnkLe fracture ImaGiNg: A feasibility randomised controlled trial examining the impact of early CT on outcomes of patients with a complex injury (ALIGN)
IRAS ID
323665
Contact name
Martine A Mallinson
Contact email
Sponsor organisation
Mid Yorkshire Teaching NHS Trust
ISRCTN Number
ISRCTN25963775
Clinicaltrials.gov Identifier
EuroQoL, 61296
Duration of Study in the UK
1 years, 1 months, 9 days
Research summary
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 always has an X-ray of their ankle if they have a fracture, but some surgeons will want a Computed Tomography (CT) scan to show more detail. Some evidence suggests that CT can support decision-making, but no research has examined how quickly this should occur and it is unclear if this delays treatment. We want to find out if doing an early CT scan could speed up treatment decisions and improve recovery.
This small research project is to help work out if it is feasible to do a larger project across multiple hospitals. We will recruit a minimum of 60 adult patients with an ankle fracture in a single hospital. Participants will be randomly allocated to two groups, similar to tossing a coin, with all treatment at the discretion of the consultant orthopaedic surgeon. One group will have the same care as they do now, including the timing of any CT imaging performed. The other group will have a CT within 12-hours of presentation at the emergency department (ED). We will follow up all participants to ask about their pain, ankle function and experiences at 6 weeks, 3 months and 6 months. We will also compare the number of hospital visits and complications in both groups.
This feasibility study is the first step in showing whether an early CT scan positively influences treatment and recovery (outcomes). The results will be presented and published internationally. This is anticipated to be the only randomised controlled trial reporting the outcomes comparing different imaging pathways for complex ankle injuries and as such will inform future research.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
24/YH/0190
Date of REC Opinion
5 Sep 2024
REC opinion
Favourable Opinion