Background: Fractures of the cervical spine’s odontoid process can result from low-impact falls in frail or older
adults, and are usually managed in hard collars to immobilise the fracture and promote bony healing. However, bony
healing often does not occur in older/frail adults and is not necessary for good outcomes. Further, hard collars can
cause complications, such as skin pressure ulcers, and difficulties with swallowing or personal care.
Objective: To examine whether management of odontoid process fractures without hard collar immobilisation is
associated with improved quality of life in older/frail patients.
Design and methods: The Duration of External Neck Stabilisation trial was a non-blinded randomised controlled
trial with a nested qualitative study.
Setting and participants: Aimed to recruit 887 participants from 25 United Kingdom hospitals, over 2 years. Eligible
patients were aged ≥ 65 years, or with Rockwood Clinical Frailty Scale of ≥ 5.
Interventions: Comparing early hard collar removal (intervention) with standard management in a hard collar for
12 weeks.
Main outcome measures: Primary outcome measure: quality of life 12 weeks following randomisation. EuroQol-5
Dimensions, five-level version.
Randomisation: Web-based randomisation system based on age, fracture type and frailty.
Blinding: Participants not blinded. Outcome event adjudication committee blinded to treatment allocation.
Results: The study was terminated prematurely because of slow recruitment. One hundred and thirty-eight patients
were randomised with. 83.3% aged > 75 years old and. 72.5% of fractures being odontoid type 2. Mean number of
days in collar 0.2 (standard deviation 1.4) for early removal of collar participants, and 55.5 days (standard deviation
38.0) for standard management participants; 15.6% of standard management participants crossed over, 3.0% of early
removal of collar participants. Twenty-eight days after randomisation, 80 patients (61.5%) were not wearing a collar. Primary end-point assessment (EuroQol 5 dimension instrument five-level version at 12 weeks), based on intentionto-treat analysis, mean score 0.650 (standard error 0.039, 0.490 to 0.86) in early removal of collar group and 0.0667
(standard error 0.040, 0.51 to 0.89) in standard management group. Pre-specified subgroup analysis by fracture type
(p = 0.3645), Rockwood score (p = 0.6593) and age (p = 0.4088) were non-significant. Qualitative study participants
reported decreased autonomy following the fracture. Standard management patients reported additional negative
impacts. There was need for better information about the injury, ‘normal’ recovery and return to activities.
Seventeen patients died; 10 (17.2%) early removal of collar group, 7 (9.8%) standard management group [odds
ratio = 1.92 (95% confidence interval 0.61 to 6.04), p = 0.266]. No deaths directly related to fracture or trial allocation.
Limitations: The study opened in 2021, during the COVID-19 pandemic. The recruited population is underpowered
considering the planned sample size. The qualitative analysis revealed several obstacles to trial recruitment, including
loss of equipoise.
Conclusions: Clinicians should consider prioritising independence and comfort of older/frail patients with odontoid
fracture by early collar removal. This study supports that this can be achieved without a clear detriment to the patient.
Future work: There is not likely equipoise for a further randomised trial, even if measures could be considered to
enhance recruitment. Instead, future prospective observational studies would be well placed to confirm and extend
our findings.
Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research
(NIHR) Health Technology Assessment programme as award number NIHR131118.
A plain language summary of this synopsis is available on the NIHR Journals Library Website https://doi.org/10.3310/
GJPB0728.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)