A radiostereometry assessment of proximal humeral fracture fixation
Research type
Research Study
Full title
A radiostereometry assessment of proximal humeral fracture fixation using a carbon reinforced PEEK locking plate.
IRAS ID
223101
Contact name
George P. Ashcroft
Contact email
Sponsor organisation
University of Aberdeen/NHS Grampian
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
The primary aim of this project is to investigate whether the x-ray technique of Radiostereometry (RSA) can be used to monitor whether fractures of the humerus fixed with plates are healing at the normal rate and whether we can identify patients whose fractures are healing slowly and may fail to heal. We also want to measure the amount of movement occurring at the fractured bone ends and the effects of physiotherapy. The fixation chosen is a carbon reinforced PEEK plate which is CE marked, in current clinical use and makes the x-ray examination easier, as it is effectively see-through on x-ray. RSA results will be compared to standard clinical outcome measures and radiographic assessment. 20 patients will have tantalum beads implanted into the fractured bone (to mark the bone for x-ray examination), in addition to the insertion of plate and screws at the time of fracture fixation. Serial RSA examinations will be taken with the arm loaded and unloaded and the movement of the bone ends at the fracture site measured. The observed fracture stability (amount of movement) will be compared across time intervals and it is expected in healing fractures that the amount of movement will decrease with time until it stops when fully healed.
REC name
North of Scotland Research Ethics Committee 1
REC reference
18/NS/0134
Date of REC Opinion
3 Dec 2018
REC opinion
Favourable Opinion