Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
Phase 4
Completed
- Conditions
- Odontoid Fractures Type II
- Registration Number
- NCT00283998
- Lead Sponsor
- AO Clinical Investigation and Publishing Documentation
- 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 \>/= 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Quality of life using the Neck disability Index 12 months Quality of life using the SF-36 12 months Proportion of bony fusion between the two treatments 6 months Proportion rate of non-union between the two treatments 6 months
- Secondary Outcome Measures
Name Time Method Rate of complications 12 months Cervical range of motion 12 months Identify the risk factors for a poor outcome independent of treatment intervention 12 months
Trial Locations
- Locations (1)
Emory University SOM: Orthopedics
🇺🇸Atlanta, Georgia, United States