Collar or no collar for peg fracture (non-REC A duplicate)
Research type
Research Study
Full title
DENS Trial: Duration of External Neck Stabilisation following odontoid fracture in older or frail adults: a randomised controlled trial of collar versus no collar
IRAS ID
299040
Contact name
Paul Brennan
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
Can odontoid (neck) fractures in older and frail people be treated safely without a hard collar?
The commonest neck fracture affects the odontoid process in the neck. Neck fractures can happen when frail and older people fall over. Patients are usually treated with a hard collar. Surgery is not needed. The collar is worn 24 hours a day for 12 weeks to limit neck movements and promote bone healing. However, bony healing doesn’t happen often in these patients. Instead, a fibrous tissue ‘scar’ forms bridging the fractured bones to stop them moving abnormally. If the collar is to promote bony healing it may therefore not be needed. Collars can cause problems. Many people wearing a collar find it hard to manage tasks such as cooking, because it limits neck movements. Collars don’t always fit well, can cause skin problems, or affect swallowing or breathing. Treatment without a collar could avoid the annoyance and potential harm, whilst the fibrous scar would still form between the fractured bones.
This question has not been studied before. Our UK-wide study is funded by the National Institute of Health Research. We will ask older (65 years or older) or frail people with an odontoid fracture to be randomly assigned to either treatment with or without a hard collar for 12 weeks. We will include people only after a spinal surgeon has decided they can be safely treated without a collar. Over 12 months we will assess whether treatment without a collar is linked to better life quality (based on questionnaires), differences in neck pain, support needs, or complications.
Patients and the public have helped design this study and are involved in its running and oversight.
The study findings will change the way patients with neck fractures are treated.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0141
Date of REC Opinion
16 Jul 2021
REC opinion
Favourable Opinion