Tibial fracture healing in static vs variable dynamisation fixation
Research type
Research Study
Full title
Assessment of bone healing time in tibial fractures; Static vs variable dynamization external fixation
IRAS ID
289401
Contact name
Hemant Sharma
Contact email
Sponsor organisation
Hull and East Yorkshire NHS trust
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
We will compare a new treatment strategy (variable reverse dynamization fixation) for adults with broken shin bones, to the existing treatment (rigid external fixation). Patients will be randomised to receive either treatment. Both Groups will undergo the same operation where a metal frame will be applied to the affected leg. In the group receiving the new treatment, the frame will be made initially slightly looser – the idea is that this will promote bone healing. Once the bone has started to heal in this group then the frame is tightened. This has shown good outcomes in animals and has been used safely on humans. Both sets of patients will receive the normal standard of care otherwise, including physiotherapy and monitoring by the hospital team.
Overall, we will measure how well the fracture heals, ankle and knee function, any complications, and the patients view on how they are doing in relation to the fracture. We also intend to perform an economic evaluation. This is a relatively small trial on 30 patients. Afterwards we intend to perform a larger study to further assess the research question.
REC name
London - Queen Square Research Ethics Committee
REC reference
21/LO/0181
Date of REC Opinion
1 Apr 2021
REC opinion
Further Information Favourable Opinion