DENS_StudyDiagram_protocol_newsletter May 2021.pdf

The Duration of External Neck Stabilisation (DENS) study is a randomised controlled trial comparing early removal of a hard collar with treatment in a hard collar for 12 weeks in older or frail adults with odontoid (dens) fractures. The primary outcome measure is QoL assessed using the EQ-5D-5L at 12 weeks following injury.  The aim of the study is to determine whether management without a collar improves outcome, compared to management with a collar. Cost efficiency will be assessed over the observed 12 months using standard NICE reference case methodology.

We are currently awaiting  REC approval and hope to begin site set up and recruitment from August 2021. If you are interested in taking part and have not already completed a feasiblity study for your site,  please contact the Trial Manager, Angela Niven (Dens.Trial@ed.ac.uk) or the Chief Investigator, Paul Brennan (paul.brennan@ed.ac.uk) 

https://www.ed.ac.uk/usher/edinburgh-clinical-trials/our-studies/all-current-studies/dens