Duration Of External Neck Stabilisation Following Odontoid Fracture In Older Or Frail Adults: A Randomised Controlled Trial Of Early Versus Late Collar Removal
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Edinburgh
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- EQ-5D-5L Score - (EuroQol five dimensional descriptive system)
Study Overview
Brief 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.
Detailed Description
This is a non-blinded randomised controlled trial with nested qualitative research comparing early removal of a hard collar (intervention) with treatment in a hard collar for 12 weeks (standard care) in older or frail adults with odontoid peg fractures. The primary outcome measure is QoL assessed using the EQ-5D-5L at 12 weeks following randomisation.
Potentially eligible participants will be assessed in the ED, or on hospital admission. Assessment of eligibility, recruitment and randomisation should take place as soon as possible (target within 48 hours) after injury. Patients with incapacity who are unable to give informed consent may still be recruited.
Exceptionally, patients who have not been assessed for eligibility at the time of their acute admission, or who were assessed but in whom there was some other delay to study inclusion, may be recruited up to 3 weeks post-injury.
Those who take part will be randomised to continuing in a hard collar for 12 weeks or to early removal of the hard collar.
During the pilot phase, a subset of patients, caregivers and health professionals will be interviewed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
No Hard Collar
Patient randomised to not wearing a Hard Collar for 12 weeks
Intervention: No Hard Collar (Other)
Standard Care Arm - Hard Collar
Patient randomised to wearing a Hard Collar for 12 weeks - standard care
Outcomes
Primary Outcomes
EQ-5D-5L Score - (EuroQol five dimensional descriptive system)
Time Frame: 12 weeks
Primary Outcome is Quality of Life assessed using the EQ-5D-5L questionnaire at 12 weeks post injury. EQ-5D-5L - Is the EuroQol 5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Secondary Outcomes
- Mortality(6 months post injury)
- Total number of hospital admissions or outpatient visits(Up to 6 months post injury)
- Total amount of health and social care visits/use(Up to 6 months post injury)
- Compliance with Hard Collar Use(Up to 12 weeks post injury)
- Length of primary admission(The total length of time between a patient's primary admission and their discharge from hospital. Up to 12 weeks after admission.)
- Discharge destination(Noted at point of discharge of participant. Usually within 12 weeks after admission.)
- Health Economics Analysis(6 months)
- Adverse events(Up to 12 weeks post injury)
- EQ-5D-5L Score - (EuroQol five dimensional descriptive system)(Measured at 2 and 6 weeks and 6 months post injury)
- Neck Disability Index (NDI)(Measured at 2, 6 and 12 weeks and 6 months post injury)
- Fracture site bony fusion(12 weeks post injury)
- Fracture site stability(12 weeks post injury)
- Loss of muscle bulk in upper limbs - assessed using a combination of grip strength and muscle bio-impedance(Measured over 12 weeks)
- Numeric Pain Rating Scale (NPRS)(Measured at 2, 6 and 12 weeks and 6 months post injury)
- Late injury-related complications(Up to 6 months post injury)