The Duration of External Neck Stabilisation (DENS) Trial

This is a non‐blinded randomised controlled trial with nested qualitative researchcomparing early removal of a hard collar (intervention) with treatment in a hard collarfor 12 weeks (standard care) in older or frail adults with odontoid peg fractures. Theprimary outcome measure is QoL assessed using the EQ‐5D‐5L at 12 weeks followingrandomisation.Potentially eligible participants will be assessed in the ED, or on hospital admission.Assessment of eligibility, recruitment and randomisation should take place as soon aspossible (target within 48 hours) after injury. Patients with incapacity who are unableto give informed consent may still be recruited.Exceptionally, patients who have not been assessed for eligibility at the time of theiracute admission, or who were assessed but in whom there was some other delay to studyinclusion, 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 toearly removal of the hard collar.During the pilot phase, a subset of patients, caregivers and health professionals will beinterviewed.In current standard care, patients with suspected cervical spine injuries are usually(but not universally) immobilised with non‐padded trauma collars or blocks, possibly onspinal boards, on admission to the ED. Early removal of this emergency immobilisation andreplacement with a padded hard collar (e.g. Miami J, Aspen, Philadelphia) as per standardcare is desirable for skin care and comfort. In this study this immobilisationreplacement will take place as usual with guidance from ED and spinal service(orthopaedic/ neurosurgical), on‐call staff, according to local protocols. This avoidsany delay in removal of emergency immobilisation that might be caused by trial proceduresto establish eligibility or consent that could lead to poorer quality of care forparticipants.All participants will undergo standard care investigations for suspected cervical spinefracture. This includes CT of the cervical spine to identify fractures, and a fullneurological examination and assessment. All participants will be discussed with theon‐call spinal (neurosurgical/orthopaedic) service unit as per usual protocols. Allparticipants will be given adequate analgesia for neck pain. Participants will only beenrolled following a consultant radiologist report of an odontoid fracture andconfirmation from the local spinal consultant that randomisation to non‐operativemanagement with or without a hard collar is appropriate.