Neck Injuries, Spinal Injuries
Conditions
Keywords
odontoid fx, surgical intervention, conservative treatment, nonunion, odontoid fractures, surgical treatment
Brief summary
The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients \> 64 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.
Detailed description
Hypotheses are as follows: * Patients receiving surgical management will exhibit better disease specific health and general health related quality of life measures compared to those managed conservatively. * The rate of radiographic bony fusion will be greater among elderly patients receiving surgical fixation compared to patients receiving conservative management. * The rate of non union will be greater in the conservative group compared to the surgical group. * The complication rate will be higher in the surgical group due to the nature of the intervention though the rate of severe and serious complications will be low.
Interventions
PROCEDUREsurgical
surgical treatment of odontoid fractures
PROCEDUREconservative treatment
conservative stabilization of fractures
Sponsors
AOSpine North America
AOSpine North America Research Network
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
64 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All new type II odontoid fractures including those in which the fracture line crosses into the body of C2 * Age \> 64 * Stable and unstable fractures * \< 3 months post-injury * No previous treatment for an odontoid fracture
Exclusion criteria
* Pathological fractures unrelated to osteoporosis * Severe dementia or severe mental health problems * Participation in other trials or unlikely to attend follow-ups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index | 12 months |
| Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients | 12 months |
| Compare the rate of non-union between the surgically and conservatively managed patients | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Compare the rate of complications | 12 months |
| Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management | 12 months |
| Identify risk factors for a poor outcome, independent of treatment intervention | 12 months |
Countries
Canada, United States
Outcome results
None listed