Treatment of Type II Odontoid Fractures Among the Elderly

AOSpine North America Research Network159 enrolled

Overview

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.

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

159

Conditions

Neck Injuries Spinal Injuries

Interventions

surgicalPROCEDURE

surgical treatment of odontoid fractures

conservative treatmentPROCEDURE

conservative stabilization of fractures

Eligibility

Sex: ALLMin age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (15)

Emory University SOM: Orthopedics

Atlanta, Georgia, United States

Indiana Spine Group

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index

Time frame: 12 months

Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients

Time frame: 12 months

Compare the rate of non-union between the surgically and conservatively managed patients

Time frame: 12 months

Secondary Outcomes

Compare the rate of complications

Time frame: 12 months

Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management

Time frame: 12 months

Identify risk factors for a poor outcome, independent of treatment intervention

Time frame: 12 months

Data from ClinicalTrials.gov

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