Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neck Injuries
- Sponsor
- AOSpine North America Research Network
- Enrollment
- 159
- Locations
- 15
- Primary Endpoint
- Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index
Time Frame: 12 months
Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients
Time Frame: 12 months
Compare the rate of non-union between the surgically and conservatively managed patients
Time Frame: 12 months
Secondary Outcomes
- 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)
- Compare the rate of complications(12 months)