Duration of external neck stabilisation in the management of older and frail patients with a new odontoid fracture: the DENS RCT

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 intention-to-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.