Diagnostic Protocol for Management of Posterior Malleolus Fractures 1
Research type
Research Study
Full title
Development of a Diagnostic Protocol to Aid the Investigation and Management of Posterior Malleolus Ankle Fractures
IRAS ID
329243
Contact name
Nicholas R Heinz
Contact email
Sponsor organisation
Uiversity of Edinburgh
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 6 days
Research summary
Fractures of the ankle make up 10% of all fractures. Of these, 7% are complex fractures involving the three sides of the ankle. Currently there is no literature reporting on the epidemiology of posterior malleolus fractures specifically even though these fractures occur with relatively high frequency. There also remains a huge debate surrounding appropriate imaging modalities required for optimal management in order to provide the best patient outcomes. Computed tomography (CT) 3-dimensional imaging has been recommended and deemed essential for pre-operative planning in order to achieve optimal anatomical reduction and outcome. Although CT scanning pre-operatively has been recommended, it may lead to over treatment of posterior malleolus fractures via an extra excessive approach which has up to a 23% complication rate.
The aim of the study is to develope a formalized protocol to aid the investigation and management of posterior malleolus fractures, with prospective validation of the devised protocol. Consultant trauma surgeons treating these complex ankle fractures will make their own assessment and plan based on the standard plain film radiographs acquired. These complex fractures warrant further 3-dimensional scanning (CT scans) pre-operatively as recommended by the British Orthopaedic Associations Standards for Trauma (BOAST). This occurs as normal outwith the study. Our devised protocol will compare trauma surgeons' surgical planning decisions post plain film radiograph compared with CT scan. Thereafter data will be collected on frequency of changes in the surgical plan.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0272
Date of REC Opinion
8 Aug 2023
REC opinion
Further Information Favourable Opinion