The Duration of External Neck Stabilisation (DENS) Trial (NCT04895644) | Clinical Trial Compass
CompletedNot Applicable
The Duration of External Neck Stabilisation (DENS) Trial
United Kingdom138 participantsStarted 2021-11-18
Plain-language summary
The Duration of External Neck Stabilisation (DENS) study is a randomised controlled trial comparing early removal of a hard collar with treatment in a hard collar for 12 weeks in older or frail adults with odontoid (dens) fractures. The primary outcome measure is QoL assessed using the EQ-5D-5L at 12 weeks following injury. The aim of the study is to determine whether management without a collar improves outcome, compared to management with a collar. Cost efficiency will be assessed over the observed 6 months using standard NICE reference case methodology.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Rockwood clinical frailty scale (CFS) of 5 or more, or aged 65 years or over;
* A recent odontoid fracture (type I-III) (within 3 weeks) as assessed on CT, irrespective of degree of fracture angulation, displacement or canal narrowing;
* History of recent trauma (within 3 weeks)
* Determined by spinal consultant (or delegated registrar) as suitable for standard care 12-week treatment with hard collar and for randomisation to treatment without a collar
* Recruited within 3 weeks of injury
Exclusion Criteria:
* New neurological deficit (numbness / weakness) attributable to fracture;
* Assessed as unable to tolerate a hard collar e.g., dystonia, fixed deformity;
* Additional (non-odontoid) cervical spine fracture not suitable for management without a hard collar;
* Underlying condition potentially leading to spinal instability, e.g., ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis (DISH);
* Fracture suspected to be older than three weeks at the time of assessment;
* Consultant spinal surgeon determines fracture requires surgical treatment or is otherwise unsuitable for non-surgical treatment with or without a hard collar;
* If not expected to survive to hospital discharge based on concomitant injuries or illnesses.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EQ-5D-5L Score - (EuroQol five dimensional descriptive system)