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Key information

Title:

Ankle Injury Rehabilitation - Comparing plaster cast to functional brace in the rehabilitation of ankle fractures.

Chief Investigator: Dr Rebecca Kearney

Sponsor: University of Warwick

Funder: National Institute of Health Research - Career Development Fellowship

Registration Number: ISRCTN15537280

Summary:

In the UK, there are 184 per 100,000 persons sustaining an ankle fracture annually. This figure is expected to increase three fold by 2030 due to a greater population of older adults. Immediate impact on the patient includes difficulty walking and pain. Longer term impact includes inability to participate in recreational/work activities and development of arthritis in the ankle.

Regardless of whether or not a patient has surgery to fix the ankle fracture, standard care involves immobilisation of the ankle in a plaster cast. The cast provides maximum support, but immobilises the ankle completely which causes muscle wastage, joint stiffness and other complications. An alternative rehabilitation plan uses a functional brace, which is a type of walking-boot that can be removed. This does not provide as much support for the ankle, but it can be removed to allow early movement of the ankle which may overcome the problems associated with rigid plaster casts. Currently there is no definitive study comparing these two approaches.

This is a pragmatic, multi centre randomised controlled trial comparing functional brace immobilisation for an ankle fracture to immobilisation in a cast. The aim is to compare the clinical and cost effectiveness of the interventions.

Sample size:

We are aiming to recruit a minimum of 478 patients, from 20 hospital sites accross the UK.

Primary outcome:

Primary outcome is the Olerud Molander Ankle Score at 16 weeks post-randomisation.

Secondary outcome measures include the Mancester-Oxford Foot and Ankle Questionnaire (MOXFQ), Health Related Quality of Life (EQ-5D-5L) and the Disability Rating Index (DRI).

Resource use, complications and x-rays will also be collected for analysis between the two groups.

Duration:

This trial will run for 5 years with a 2 year follow up period.


 

Enquiries:

AIR Trial Manager: Rebecca McKeown
 
Tel: 02476 968622
Mob: 07469 020712

Email: AIR@warwick.ac.uk