Treatment of Type II Odontoid Fractures Among the Elderly
- Conditions
- Spinal InjuriesNeck Injuries
- Interventions
- Procedure: conservative treatmentProcedure: surgical
- Registration Number
- NCT00266929
- Lead Sponsor
- AOSpine North America Research Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- 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
- Pathological fractures unrelated to osteoporosis
- Severe dementia or severe mental health problems
- Participation in other trials or unlikely to attend follow-ups
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-surgical conservative treatment Subjects treated with non-operative treatment options Surgical surgical Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation)
- Primary Outcome Measures
Name Time Method Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index 12 months Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients 12 months Compare the rate of non-union between the surgically and conservatively managed patients 12 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (15)
Emory University SOM: Orthopedics
🇺🇸Atlanta, Georgia, United States
Indiana Spine Group
🇺🇸Indianapolis, Indiana, United States
John Hopkins University
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Cornell Weill Medical College
🇺🇸New York, New York, United States
Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Mayo Clinic
🇺🇸Rochester, Minnesota, United States