- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00266929
Treatment of Type II Odontoid Fractures Among the Elderly
August 9, 2017 updated by: AOSpine North America Research Network
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
159
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5T 258
- Toronto Western Hospital
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-
-
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Georgia
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Atlanta, Georgia, United States, 30329
- Emory University SOM: Orthopedics
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Indiana
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Indianapolis, Indiana, United States, 46260
- Indiana Spine Group
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Kansas
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Kansas City, Kansas, United States, 66160
- Kansas University Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287
- John Hopkins University
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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New York
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New York, New York, United States, 10021
- Cornell Weill Medical College
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Ohio
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Cleveland, Ohio, United States
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
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Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Washington
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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West Virginia
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Morgantown, West Virginia, United States, 26506
- West Virginia University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
64 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects receiving care for acute Type II Odontoid Fracture in participating investigational sites
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pathological fractures unrelated to osteoporosis
- Severe dementia or severe mental health problems
- Participation in other trials or unlikely to attend follow-ups
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgical
Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation)
|
surgical treatment of odontoid fractures
|
Non-surgical
Subjects treated with non-operative treatment options
|
conservative stabilization of fractures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index
Time Frame: 12 months
|
12 months
|
Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients
Time Frame: 12 months
|
12 months
|
Compare the rate of non-union between the surgically and conservatively managed patients
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the rate of complications
Time Frame: 12 months
|
12 months
|
Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management
Time Frame: 12 months
|
12 months
|
Identify risk factors for a poor outcome, independent of treatment intervention
Time Frame: 12 months
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alexander R Vaccaro, MD, Thomas Jefferson University and The Rothman Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Smith HE, Kerr SM, Maltenfort M, Chaudhry S, Norton R, Albert TJ, Harrop J, Hilibrand AS, Anderson DG, Kopjar B, Brodke DS, Wang JC, Fehlings MG, Chapman JR, Patel A, Arnold PM, Vaccaro AR. Early complications of surgical versus conservative treatment of isolated type II odontoid fractures in octogenarians: a retrospective cohort study. J Spinal Disord Tech. 2008 Dec;21(8):535-9. doi: 10.1097/BSD.0b013e318163570b.
- Smith HE, Vaccaro AR, Maltenfort M, Albert TJ, Hilibrand AS, Anderson DG, Harrop J, Fehlings MG, Kopjar B, Brodke DS, Arnold PM, Shaffrey CI. Trends in surgical management for type II odontoid fracture: 20 years of experience at a regional spinal cord injury center. Orthopedics. 2008 Jul;31(7):650.
- Vaccaro AR, Kepler CK, Kopjar B, Chapman J, Shaffrey C, Arnold P, Gokaslan Z, Brodke D, France J, Dekutoski M, Sasso R, Yoon ST, Bono C, Harrop J, Fehlings MG. Functional and quality-of-life outcomes in geriatric patients with type-II dens fracture. J Bone Joint Surg Am. 2013 Apr 17;95(8):729-35. doi: 10.2106/JBJS.K.01636.
- Fehlings MG, Arun R, Vaccaro AR, Arnold PM, Chapman JR, Kopjar B. Predictors of treatment outcomes in geriatric patients with odontoid fractures: AOSpine North America multi-centre prospective GOF study. Spine (Phila Pa 1976). 2013 May 15;38(11):881-6. doi: 10.1097/BRS.0b013e31828314ee.
- Chapman J, Smith JS, Kopjar B, Vaccaro AR, Arnold P, Shaffrey CI, Fehlings MG. The AOSpine North America Geriatric Odontoid Fracture Mortality Study: a retrospective review of mortality outcomes for operative versus nonoperative treatment of 322 patients with long-term follow-up. Spine (Phila Pa 1976). 2013 Jun 1;38(13):1098-104. doi: 10.1097/BRS.0b013e318286f0cf.
- Smith HE, Kerr SM, Fehlings MG, Chapman J, Maltenfort M, Zavlasky J, Harris E, Albert TJ, Harrop J, Hilibrand AS, Anderson DG, Vaccaro AR. Trends in epidemiology and management of type II odontoid fractures: 20-year experience at a model system spine injury tertiary referral center. J Spinal Disord Tech. 2010 Dec;23(8):501-5. doi: 10.1097/BSD.0b013e3181cc43c7.
- Smith JS, Kepler CK, Kopjar B, Harrop JS, Arnold P, Chapman JR, Fehlings MG, Vaccaro AR, Shaffrey CI. Effect of type II odontoid fracture nonunion on outcome among elderly patients treated without surgery: based on the AOSpine North America geriatric odontoid fracture study. Spine (Phila Pa 1976). 2013 Dec 15;38(26):2240-6. doi: 10.1097/BRS.0000000000000009.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
December 19, 2005
First Submitted That Met QC Criteria
December 19, 2005
First Posted (Estimate)
December 20, 2005
Study Record Updates
Last Update Posted (Actual)
August 11, 2017
Last Update Submitted That Met QC Criteria
August 9, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-GOF-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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