Collar or no collar for peg fracture
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
286604
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
Summary of Research
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.Summary of Results
What was the question?
Older people who fall can break a bone in their neck called the ‘odontoid process’ or ‘dens.’ Doctors usually advise patients to wear a firm (hard) collar around their neck for several weeks. These collars can cause skin sores, and difficulties with swallowing or personal care. Importantly, the fracture can still repair when a hard collar is not used, and patients recover perfectly well.
We therefore wanted to know whether managing patients without a hard collar was actually associated with better quality of life.What did we do?
In the Duration of External Neck Stabilisation (DENS) trial, patients diagnosed with a new odontoid neck fracture, who consented, were allocated to either wearing a hard collar or not wearing a collar. The allocation was at random, which means we didn’t know in advance whether a particular patient would end up wearing a collar or not. We then assessed how patients felt (their quality of life) during their recovery, using a questionnaire.What did we find?
138 people took part, fewer than the 887 we had intended. The study opened in 2021, during the COVID-19 pandemic. This made recruitment difficult.
Many patients who were allocated to wear a hard collar ended up removing it early, or only wearing it some of the time. We did not find a big difference in how patients felt, whether they had been instructed to wear a collar or not. This could be because we recruited too few patients, or because so many people removed their collars before they were meant to. Patients highlighted that they need better information about the injury, ‘normal’ recovery, and return to activities.What does this mean?
Doctors can prioritise the independence and comfort of older patients with odontoid fractures by managing them without a hard collar.REC name
Scotland A: Adults with Incapacity only
REC reference
21/SS/0036
Date of REC Opinion
10 Jun 2021
REC opinion
Favourable Opinion