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

Woodfield, J. et al. (2022) 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. BMJ Open, 12(7), e057753. (doi: 10.1136/bmjopen-2021-057753) (PMID:35840308) (PMCID:PMC9295672)

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.

• Item Type: Articles
• Additional Information: This work was supported by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) grant number 131118. EE, JW, MJR, CK, JN, DJL, SDS, and PFXS are supported by this grant.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Lowe, Dr David
• Authors: Woodfield, J., Edlmann, E., Black, P. L., Boyd, J., Copley, P. C., Cranswick, G., Eborall, H., Keerie, C., Khan, S., Lawton, J., Lowe, D. J., Norrie, J., Niven, A., Reed, M. J., Shenkin, S. D., Statham, P., Stoddart, A., Tomlinson, J., and Brennan, P. M.
• College/School: College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: BMJ Open
• Publisher: BMJ Publishing Group
• ISSN: 2044-6055
• ISSN (Online): 2044-6055
• Published Online: 15 July 2022
• Copyright Holders: Copyright © 2022 The Authors
• First Published: First published in BMJ Open 12(7): e057753
• Publisher Policy: Reproduced under a Creative Commons License