dens fracture Fractured odontoid process
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - At least 55 years old - Acute type II and III odontoid fracture according to Anderson and d*Alonzo classification (possibly in combination with other fractures); diagnosed using computed tomography - Less than two weeks after injury - Informed consent
Exclusion criteria
Exclusion criteria: - Rheumatoid arthritis - Ankylosing spondylitis - Previous treatment for odontoid fracture - Communication with patient is hampered (e.g. language barrier, severe cognitive impairment, coma)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Clinical outcome, scored by the Neck Disability Index at 52 weeks after start of treatment - Fracture healing, assessing union (union or non-union) and stability at 52 weeks after start of treatment Union will be defined by evidence of bone trabeculae crossing the fracture site and absence of sclerotic borders adjacent to the fracture site, assessed using computed tomography (CT). Fracture stability will be assessed using cervical dynamic X-rays in lateral projection. A maximum of 2 mm movement at the fracture site is considered stable. Imaging data will be sent to the coordinating centre and will be judged by independent assessors (neuroradiologists) who are blinded to the results. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical: Myelopathy Disability Index, VAS neck pain score, SF-36, EQ5D, DS14 (psychometric properties), IPQ-K (illness perception), Likert Radiological: Fracture displacement, grade of osteoporosis in C2, grade of degeneration of C1-C2 facet joints, pseudoarthrosis General: Complications, reinterventions (secondary surgery, surgery after failed conservative treatment) | — |
Countries
Netherlands
Outcome results
None listed