Trials / Completed
CompletedNCT00266929
Treatment of Type II Odontoid Fractures Among the Elderly
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 159 (actual)
- Sponsor
- AOSpine North America Research Network · Network
- Sex
- All
- Age
- 64 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | surgical | surgical treatment of odontoid fractures |
| PROCEDURE | conservative treatment | conservative stabilization of fractures |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2010-05-01
- Completion
- 2010-05-01
- First posted
- 2005-12-20
- Last updated
- 2017-08-11
Locations
15 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00266929. Inclusion in this directory is not an endorsement.