Odontoid Fractures Type II Clinical Trial
Official title:
Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures
The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients >/= 65 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.
Status | Completed |
Enrollment | 166 |
Est. completion date | March 2012 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - All new type II odontoid fractures including < those in which the fracture line crosses into the body of C2 < as long as it doesn't enter the superior articular process of C2 - Age 65+ - Stable and unstable fractures - < 3 months postinjury - No previous treatment for an odontoid fracture Exclusion Criteria: - Pathologic fractures unrelated to osteoporosis - Severe dementia or other severe mental health problem if there is no consentable surrogate available - Participating in other trials or unlikely to attend follow-ups |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University SOM: Orthopedics | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
AO Clinical Investigation and Documentation | AOSpine North America |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life using the Neck disability Index | 12 months | No | |
Primary | Quality of life using the SF-36 | 12 months | No | |
Primary | Proportion of bony fusion between the two treatments | 6 months | No | |
Primary | Proportion rate of non-union between the two treatments | 6 months | No | |
Secondary | Rate of complications | 12 months | No | |
Secondary | Cervical range of motion | 12 months | No | |
Secondary | Identify the risk factors for a poor outcome independent of treatment intervention | 12 months | No |