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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the long-term outcomes of surgical vs. conservative management for Type II odontoid fractures in elderly patients (NCT00283998)?
How does anterior screw fixation compare to posterior fusion in terms of complication rates and healing success for Type II odontoid fractures?
Which biomarkers, such as bone mineral density or comorbidities, predict better outcomes with surgical or conservative treatment in elderly Type II odontoid fracture patients?
What are the adverse event profiles and management strategies for surgical versus conservative approaches in treating Type II odontoid fractures among the elderly?
Are there alternative surgical techniques or devices that show improved efficacy over anterior screw fixation or posterior fusion for Type II odontoid fractures in the elderly?
Trial Locations
- Locations (1)
Emory University SOM: Orthopedics
🇺🇸Atlanta, Georgia, United States
Emory University SOM: Orthopedics🇺🇸Atlanta, Georgia, United States