Clinical trial NCT00266929: Treatment of Type II Odontoid Fractures Among the Elderly
Official title: Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Injuries
Spinal Injuries
Keywords: odontoid fx
surgical intervention
conservative treatment
nonunion
odontoid fractures
surgical treatment
Lead sponsor: AOSpine North America Research Network
Sponsor class: NETWORK
Collaborators: name: AOSpine North America
First posted: 2005-12-20
Enrollment: 159
Sex: ALL
Minimum age (years): 64
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects receiving care for acute Type II Odontoid Fracture in participating investigational sites

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index
timeFrame: 12 months
measure: Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients
timeFrame: 12 months
measure: Compare the rate of non-union between the surgically and conservatively managed patients
timeFrame: 12 months
Secondary outcomes:
measure: Compare the rate of complications
timeFrame: 12 months
measure: Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management
timeFrame: 12 months
measure: Identify risk factors for a poor outcome, independent of treatment intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University SOM: Orthopedics
state: Georgia
city: Indianapolis
country: United States
facility: Indiana Spine Group
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Cornell Weill Medical College
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Thomas Jefferson University and The Rothman Institute
name: Alexander R Vaccaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.