Treatment of Type II Odontoid Fractures Among the Elderly
NCT ID: NCT00266929
Last Updated: 2017-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
159 participants
OBSERVATIONAL
2005-12-31
2010-05-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgical
Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation)
surgical
surgical treatment of odontoid fractures
Non-surgical
Subjects treated with non-operative treatment options
conservative treatment
conservative stabilization of fractures
Interventions
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surgical
surgical treatment of odontoid fractures
conservative treatment
conservative stabilization of fractures
Eligibility Criteria
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Inclusion Criteria
* Age \> 64
* Stable and unstable fractures
* \< 3 months post-injury
* No previous treatment for an odontoid fracture
Exclusion Criteria
* Severe dementia or severe mental health problems
* Participation in other trials or unlikely to attend follow-ups
64 Years
ALL
Yes
Sponsors
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AOSpine North America
INDUSTRY
AOSpine North America Research Network
NETWORK
Responsible Party
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Principal Investigators
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Alexander R Vaccaro, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University and The Rothman Institute
Locations
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Emory University SOM: Orthopedics
Atlanta, Georgia, United States
Indiana Spine Group
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
John Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Cornell Weill Medical College
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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07-GOF-05
Identifier Type: -
Identifier Source: org_study_id
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