Ultrasound microbubbles for bone fracture
Research type
Research Study
Full title
Ultrasound microbubbles for bone fracture
IRAS ID
290051
Contact name
Nicholas D Evans
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Bone fractures are a huge problem. They cost ~£2 billion/year in the UK. This figure will get bigger as the average age of the people in the UK increases. A big part of this cost comes from non-union or delayed-union bone fracture, which affect about 5-10% of cases. These poorly healing bone fractures are devastating for the person affected, sometimes taking many years of major surgery and extensive rehabilitation. They cost a huge amount too – estimated at £40-50,000/patient, with the total cost in the UK estimated at £350m every year. There are no drugs and very few therapies that have been proven to be efficacious in improving healing in non-union or delayed union. One reason that they may not heal properly may be a lack of site-specific drug delivery, nutrient transport or mechanobiological stimulation at the site of injury. We want to try and improve this by developing ultrasound-responsive microbubbles that are carried to the site of fracture and may be triggered to promote nutrient uptake, mechanobiological stimulation and delivery using clinical ultrasound devices. We have extensive preliminary data to support the utility of this approach.\n\nOur key research question for this ethics application is: can we deliver and track ultrasound-responsive microbubbles at a bone fracture site? This is part of our longer-term aim to develop a method for site specific activation of microbubbles in patients. To achieve this, we intend to:\n\n•\tRecruit patients with fracture in the tibia, humerus, radius or ulna bones\n•\tInject patients intravenously with ultrasound microbubble contrast agents (‘MBs’; these are clinically approve formulations that are routinely used for ultrasound imaging in cardiovascular medicine) \n•\tImage using ultrasound at fracture gap before and during injection to test the hypothesis that MBs can be detected at fracture sites.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0032
Date of REC Opinion
10 Mar 2021
REC opinion
Favourable Opinion