Background
Background and rationale
Evidence
Implications of this study
Methods
Study aims and objectives
Primary objective
Secondary objective
Trial design
Study setting
Eligibility criteria
Inclusion criteria
Exclusion criteria
Interventions
Concomitant treatment in both groups
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Collar in emergency department (Stifneck, Laerdal Medical, Stockholm Sweden)
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Pain medication (bolus: 2–5 mg morphine by the intravenous (IV) route)
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Diagnostic workup
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Baseline data collection according to Fig. 2
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Expertise of participating physicians: beginner (residents) to expert (consultant)
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Follow-up after 6 weeks, 3 months and 1 year, according to Fig. 2
Non-surgical treatment
Surgical treatment
Study outcome measures
Primary outcome measure
Secondary outcome measures
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EQ-5D score
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Katz ADL (Activities of Daily Living score) at baseline and at 1 year
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Visual Analogous Scale (VAS) at baseline and at 1 year
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Mortality
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Serious adverse events (including death) during the first year
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Radiographically demonstrable healing on CT after 1 year
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Upper cervical stability on dynamic flexion-extension radiographs of the cervical spine after 1 year
Subgroup analysis
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Socio-demographics
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▪ Age
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▪ Gender (male/female)
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▪ Body Mass Index (BMI)
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▪ American Society of Anaesthesiologists (ASA) class
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▪ Smoking (yes/no)
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Type-2 odontoid fracture subgroup
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▪ Grauer classification [15]
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Type of posterior C1–C2 fusion
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▪ Goel-Harms technique or Magerl-Atlas claw technique
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Osteoporosis (dual energy x-ray absorptiometry (DXA) score)
Participant timeline
Recruitment
Assignment of intervention
Allocation
Sequence generation
Blinding
Study instruments
Neck Disability Index
EuroQol health-related quality of life questionnaire (EQ-5D)
Katz ADL Index
Computer tomography
Extension flexion plain radiograph
Dual energy X-ray absorptiometry
Data collection, management and analysis
Data collection and management
Access to data
Statistics
Variable/Outcomes | Hypothesis | Outcome measures | Methods of analysis |
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Baseline data:
| There is no difference between the two groups | Gender, age, Katz ADL, CCI, nursing home/hospitalisation, smoking status | Absolute numbers, percentages for categorical variables and the minimum, maximum, mean, SD and quartiles for quantitative variables |
Primary:
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Function | There is a clinically important difference between the two groups, with improvement comparing baseline data with data from 6 weeks, 12 weeks, and 1 year. Surgical treatment is hypothesised to be superior | NDI (0–100%) [continuous] | Student t test, chi-square, Mann-Whitney, Fisher’s exact test. Time-dependent differences between AUC |
Secondary:
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Health-related quality of life | There is a clinically important difference between the two groups | EQ-5D [continuous] | Student t test, chi-square, Mann-Whitney, Fisher’s exact test Time-dependent differences between AUC |
Pain | There is a clinically important difference between the two groups | VAS (0–100) [continuous] | Students t test, chi-square, Mann-Whitney, Fisher exact test Time-dependent differences between AUC |
Non-union | The non-union rate is lower in the surgical group | Bone bridge in CT [binary], mobility on extension-flexion radiographs [binary], | Chi-square test |
Mortality | The survival is greater in the surgical group | all-cause mortality [binary], time to death [continuous, censored] | Kaplan-Meier analysis, Cox regression models, additional subdistribution hazards approach |
Osteoporosis | There is no difference between the two groups | The bone density is > 2.5 standard deviations below normal DXA T-score [binary] | Chi-square |
Subgroup analysis:
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septuagenarians vs. octogenarians vs. nonagenarians | Treatment effect is diminished in nonagenarians | ||
Goel-Harms technique vs. Magerl technique | There is no difference between the two groups | ||
Male vs. female | There is no difference between the two groups | ||
Sensitivity analysis:
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Per-protocol analysis | All outcomes | Students t test, chi-square, Mann-Whitney, Fisher exact test | |
Adjusting for baseline covariates | All outcomes | Uni-and multivariate adjusted logistic regression and Cox proportional hazard models | |
Adjusting for mortality | All outcomes | subdistribution hazards approach |