Title: DENS RCT: Duration of External Neck Stabilisation following odontoid fracture in older or frail adults: a randomised controlled trial of collar versus no collar
Funder: Chief Scientist Office, Scotland

Abstract: This is a trial on how best to treat older or frail people with the most common type of neck fracture, known as odontoid (or dens) fracture. It will compare management with a hard collar against management without a collar. _x000D_ _x000D_ Neck fractures can happen when frail and older people fall over. For odontoid fractures people are usually treated with a hard collar. Surgery can be high risk with many complications. Studies show that older people using a hard collar to treat the fracture get similar levels of bone healing and improvement in neck symptoms as those treated with surgery. _x000D_ _x000D_ The hard collar is usually worn 24 hours a day for 12 weeks to prevent neck movements, to allow the bones to heal. However, bony healing doesn’t happen very often in older or frail people. Instead, fibrous tissue forms that links the fractured bones and stops them moving abnormally. Healing with fibrous tissue seems as good as bony healing in older people. _x000D_ _x000D_ Many people whose neck fracture is managed with a hard collar need help at home to hold the neck still for personal care. Some find it hard to manage with cooking or cleaning and may need extra help. Wearing a hard collar may mean longer in hospital. Hard collars don’t always fit well and can cause skin problems or affect swallowing or breathing. _x000D_ _x000D_ There haven’t been any studies looking at whether management with a hard collar is necessary or useful for treating odontoid fractures. We will ask older (aged 65 years or older) or frail people with these fractures to be randomly assigned to either treatment without a hard collar or with a hard collar for 12 weeks; and will continue to follow-up all patients as usual._x000D_ _x000D_ Anyone with a suspected or actual neck fracture usually has a hard collar put on in the Emergency Department. This is for safety reasons whilst they are being investigated and a treatment plan made. Some people have conditions which require surgery. Some fractures might not be suitable for management without a hard collar. We will only include people in this study after a spinal surgeon has decided that they do not need an operation and are safe to be treated without a hard collar. As most people will already be wearing a hard collar when they agree to take part, the study will look at removing this immediately, compared to treatment with a hard collar for 12 weeks._x000D_ _x000D_ Everyone taking part in the study will complete a questionnaire about their life quality 12 weeks after the fracture. If people can’t answer the questionnaire themselves, we will ask the person who knows them best to complete it. We will interview some of those taking part and a close relative to see how they manage and what needs they might have during the 12 weeks. We will see whether treatment without a hard collar is linked to better or worse life quality than with a hard collar; and whether there are differences in neck pain, support needs, and complications. We will follow everyone up for a year after the fracture to check that there are no longer term differences between those treated with or without a hard collar._x000D_ _x000D_ Patients and the public have been involved in designing this study and in writing this application. They will be involved in running the study and looking at the results._x000D_ _x000D_ The study findings could change the way that older and frail people with neck fractures are treated. We will work with NHS decision makers and those developing guidelines to ensure that the results change patient care as quickly as possible.

Lay abstract: Research Question_x000D_ Are hard collars necessary for odontoid fractures in older and frail patients? _x000D_ _x000D_ Background_x000D_ Odontoid (dens)fractures following low impact falls in frail or older people are increasing in incidence. Standard care in a hard collar aims to promote bony healing by immobilisation, prevent neck instability pain, and avoid neurological deficits. However, hard collars can cause skin pressure ulcers and necessitate increased care for activities of daily living (ADL). Neurological deficits are very rare and bony fusion rates highly variable - up to 80% do not achieve bony fusion. Fractures without bony fusion often have stable fibrous non-bony union. QoL and pain scores do not appear dependent on whether bony union occurs. The hard collar may therefore not be necessary. Not using a collar could avoid the harm and impact on ADL that hard collars can have. _x000D_ _x000D_ EQ-5D-5L was chosen as primary outcome measure after literature review, discussion with patients and PPI groups. It was preferred as easy to complete, covers domains relevant to trial population, is responsive to change and is validated for proxy completion if necessary. _x000D_ _x000D_ Aims _x000D_ To determine whether management without a collar improves outcome in older or frail patients with a new odontoid fracture compared to standard care hard collar for 12 weeks. _x000D_ _x000D_ Objectives_x000D_ To determine difference in QoL assessed with EQ-5D-5L at 12 weeks between the no collar and collar arms. Secondary objectives include Neck Disability Index, mortality, adverse events, a qualitative process evaluation study to assess perceptions and acceptability of the intervention amongst patients and clinicians, objective measure of collar compliance using thermal sensors, and health economic analysis._x000D_ _x000D_ Methods_x000D_ Randomised controlled trial of adults aged =65 or with a Rockwood clinical frailty score of =5. Odontoid fracture diagnosis will be confirmed by consultant radiologist and study eligibility confirmed by consultant spinal surgeon. Recruitment up to 3 weeks from injury, allowing time to recover capacity if acutely compromised. Patients in both study arms will have assessments at 2,6, and 12 weeks, and 6 and 12-months following injury, alongside standard care clinical review._x000D_ _x000D_ Recruit 887 participants over 2 years, to detect a minimum clinically important difference of 0.05 on EQ-5D-5L using repeated measures over 12 weeks at 90% power with a 5% significance level. An internal pilot study to assess recruitment feasibility will be undertaken - 132 (15%) patients, 18 centres, within 9 months. Stop/go criteria have been defined. A second internal pilot will re-estimate sample size using a simulation approach after the first 300 patients, because of some uncertainty in assumptions used to determine sample size._x000D_ _x000D_ Timelines for delivery _x000D_ Commence Feb 2021. REC submission April 2021. Aug 2021 Internal pilot phase and process evaluation begins. Pilot Ends April 2022. Main study recruitment ends Aug 2023. Follow-up complete Aug 2024. Report Feb 2025_x000D_ _x000D_ Anticipated impact and Dissemination_x000D_ This study will provide definitive evidence that hard collars are not needed for older and frail patients with odontoid fractures. This will rapidly impact on clinical pathways and guidelines (e.g. NICE), as simple to implement. Dissemination through conference presentations, peer review journals and plain language summary. Medium-term potential for substantial hospital and social care cost savings.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: MUSCULOSKELETAL