Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar
John Norrie,
Julie Woodfield,
David J Lowe,
Paul M Brennan,
Catriona Keerie,
Julia Lawton,
Matthew J Reed,
Andrew Stoddart,
Julia Boyd,
Helen Eborall,
Gina Cranswick,
James Tomlinson,
Polly L Black,
Sadaquate Khan,
Patrick Statham,
Ellie Edlmann,
Phillip Correia Copley,
Angela Niven,
Susan Deborah Shenkin
Affiliations
John Norrie
professor of medical statistics and trial methodology
Julie Woodfield
Department of Clinical Neurosciences, NHS Lothian, Edinburgh, UK
David J Lowe
Department of Emergency, Queen Elizabeth University Hospital Campus, Glasgow, UK
Paul M Brennan
Translational Neurosurgery, Centre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, UK
Catriona Keerie
University of Edinburgh College of Medicine and Veterinary Medicine, Edinburgh, UK
Julia Lawton
University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UK
Matthew J Reed
Emergency Medicine Research Group Edinburgh (EMERGE), NHS Lothian, Edinburgh, UK
Andrew Stoddart
Edinburgh Health Services Research Unit, The University Of Edinburgh, Edinburgh, UK
Julia Boyd
5 Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, 3 Little France Road, Edinburgh, UK
Helen Eborall
The University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UK
Gina Cranswick
Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK
James Tomlinson
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
Polly L Black
Emergency Medicine Research Group (EMERGE), NHS Lothian, Edinburgh, UK
Sadaquate Khan
Department of Clinical Neurosciences, NHS Lothian, Edinburgh, UK
Patrick Statham
Institute of Medical and Biological Engineering, Faculty of Engineering and Physical Sciences, University of Leeds, Leeds, UK
Ellie Edlmann
Southwest Neurosurgical Centre, Derriford Hospital, Plymouth, UK
Phillip Correia Copley
Department of Clinical Neurosciences, NHS Lothian, Edinburgh, UK
Angela Niven
Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK
Susan Deborah Shenkin
University of Edinburgh Usher Institute of Population Health Sciences and Informatics, Edinburgh, UK
Introduction Fractures of the odontoid process frequently result from low impact falls in frail or older adults. These are increasing in incidence and importance as the population ages. In the UK, odontoid fractures in older adults are usually managed in hard collars to immobilise the fracture and promote bony healing. However, bony healing does not always occur in older adults, and bony healing is not associated with quality of life, functional, or pain outcomes. Further, hard collars can cause complications such as skin pressure ulcers, swallowing difficulties and difficulties with personal care. We hypothesise that management with no immobilisation may be superior to management in a hard collar for older or frail adults with odontoid fractures.Methods and analyses This is the protocol for the Duration of External Neck Stabilisation (DENS) trial—a non-blinded randomised controlled trial comparing management in a hard collar with management without a collar for older (≥65 years) or frail (Rockwood Clinical Frailty Scale ≥5) adults with a new odontoid fracture. 887 neurologically intact participants with any odontoid process fracture type will be randomised to continuing with a hard collar (standard care) or removal of the collar (intervention). The primary outcome is quality of life measured using the EQ-5D-5L at 12 weeks. Secondary outcomes include pain scores, neck disability index, health and social care use and costs, and mortality.Ethics and dissemination Informed consent for participation will be sought from those able to provide it. We will also include those who lack capacity to ensure representativeness of frail and acutely unwell older adults. Results will be disseminated via scientific publication, lay summary, and visual abstract. The DENS trial received a favourable ethical opinion from the Scotland A Research Ethics Committee (21/SS/0036) and the Leeds West Research Ethics Committee (21/YH/0141).Trial registration number NCT04895644.
