Ankle Fracture Study
Research type
Research Study
Full title
Investigating the Impact of Engineered Compression Stockings in the Treatment of Ankle Fractures: A Multicentre, Randomised, Control Trial
IRAS ID
126450
Contact name
Charles McCollum
Contact email
Research summary
Over 86, 000 individuals suffer an ankle fracture every year in the UK; the majority being young men and elderly women. Recovery after an ankle fracture is poor, with most patients reporting persistent ankle pain, swelling and stiffness after two years. Half of patients never return to pre-injury physical health and quality of life is frequently impaired. Ankle fractures are commonly complicated by venous thromboembolism (VTE), with a frequency in the range 11-31%. In our pilot study, 17% of patients with an ankle fracture developed a deep vein thrombosis (DVT), a frequency halved by elastic compression stockings.
Compression is not routinely used in ankle fracture management. Ankle Injury Stockings (AIS) are a novel new technology developed by the Departments of Textiles and Academic Surgery at the University of Manchester. AIS are based on engineered compression stockings; a precise laser profile of the leg is used to program a computerised flat-bed knitting machine to produce a precisely fitting, seamless elastic stocking that accurately delivers the pressure prescribed by the doctor. AIS have been designed with a wide elastic range so that they can be applied more easily over a painful, swollen ankle without compromising the pressure profile.
We propose a definitive multi-centre RCT in 1000 patients to assess the impact of AIS in the treatment of ankle fractures. We aim to answer the following research questions:
1. Do patients with ankle fractures randomised to AIS + Aircast boot subsequently suffer a lower frequency of VTE than patients treated with the Aircast boot alone?
2. Do patients with ankle fractures randomised to the AIS + Aircast boot subsequently have better functional outcomes measured using the Manchester Oxford Foot and Ankle Score?
3. Do AIS + Aircast improve health-related quality of life measured using the EuroQol (EQ-5D)?
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0427
Date of REC Opinion
13 Apr 2015
REC opinion
Further Information Favourable Opinion