The Duration of External Neck Stabilisation (DENS) Trial

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 outcome is Quality of Life assessed using the EQ-5D-5L questionnaire at 2 and 6 weeks and 6 months 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.

The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's neck pain related disability. Each question is measured on a scale from 0 (no disability) to 5, and an overall score out of 50 is calculated by adding each item score together. This score is then multiplied by two to give a percentage score. A higher NDI score means the greater a patient's perceived disability due to neck pain.

The Numeric Pain Rating Scale is used to measure the patient's perception of their neck pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain imaginable. This data can be collected on paper or over the phone.

Mortality

Adverse events

In fracture site bony fusion at approximately 12 weeks assessed on imaging (CT, flexion-extension x-rays or MRI) where performed as part of standard care

In fracture site stability at approximately 12 weeks assessed on imaging (CT, flexion-extension x-rays or MRI) where performed as part of standard care

Loss of muscle bulk in upper limbs will be assessed using grip strength and muscle bio-impedance.

In consenting participants, hand grip strength will be measured using a dynamometer. Participants will be seated, their elbow by their side and flexed to right angles, and a neutral wrist position. The mean of three trials of grip strength will be reported for each hand.

Bioelectric impedance (Bio-impedance) analysis measurements will be made at the right wrist and ankle, with the subject supine. Muscle mass is calculated according to Janseen et al.

skeletal muscle mass (kg) =[height2/Bioimepedance x 0.401) +(gender x 3.825) +(age x -0.071)] +5.102

where height is in centimetres, Bio-impedance in ohms, gender male =1 and female=0, and age is in years. The skeletal muscle index in kg/m2 is obtained by dividing the muscle mass by squared height.

Late injury-related complications, such as new neurological deficit

In patient hospitalisations including outpatient visits and total inpatient bed days

Health care, community health and social care use and primary care visits

Compliance with Hard Collar wear in a sample of patients. iButtons or similar will be placed inside the hard collar of a small sample of patients. These buttons record variations in temperature and can therefore measure compliance with collar wear.

Length of primary admission

The location the patient will be discharged to eg. home, care home

A 6 month within trial analysis will be undertaken based on National Institute for Health and Care Excellence (NICE) reference case recommendations to maximise UK policy relevance. This will include: Adoption of an National Health Service (NHS) and Personal Social Services (PSS) decision perspective; cost-utility approach for primary analysis (results presented in terms of incremental cost per quality adjusted life year (QALY) derived from EQ-5D-5L data with an area under the curve approach, omitting baseline); discount rate of 3.5% for both costs and QALYs (where applicable); and use of probabilistic sensitivity analysis (PSA), to generate cost effectiveness acceptability curves (CEACs). Choice of primary analysis cost per QALY threshold and EQ-5D-5L scoring algorithm will be selected to match NICE preferences. NHS & PSS resource use will be extracted from medical records with some top-up self-report surveying. These will be combined with standard UK price weights to generate costs.