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

Julie Woodfield, Ellie Edlmann, Polly L Black, Julia Boyd, Phillip Correia Copley, Gina Cranswick, Helen Eborall, Catriona Keerie, Sadaquate Khan, Julia Lawton, David J Lowe, John Norrie, Angela Niven, Matthew J Reed, Susan Deborah Shenkin, Patrick Statham, Andrew Stoddart, James Tomlinson, Paul M Brennan, Julie Woodfield, Ellie Edlmann, Polly L Black, Julia Boyd, Phillip Correia Copley, Gina Cranswick, Helen Eborall, Catriona Keerie, Sadaquate Khan, Julia Lawton, David J Lowe, John Norrie, Angela Niven, Matthew J Reed, Susan Deborah Shenkin, Patrick Statham, Andrew Stoddart, James Tomlinson, Paul M Brennan

Abstract

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.

Keywords: neurosurgery; orthopaedic & trauma surgery; protocols & guidelines.

Conflict of interest statement

Competing interests: MJR is supported by an NHS Research Scotland Career Researcher Clinician award. EE is supported by Plymouth Charitable Fund and a University of Plymouth pump priming grant. All other authors declared no competing interests.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
DENS trial flow chart. C-spine, cervical spine; CTU, Clinical Trials Unit; DENS, Duration of External Neck Stabilisation; DISH, diffuse idiopathic skeletal hyperostosis; NDI, Neck Disability Index; RCT, randomised controlled trial; VAS, Visual Analogue Scale; OPD, Outpatient Department; EQ-5D-5L, EuroQol 5 dimension instrument 5 level version.

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