Treatment of Type II Odontoid Fractures Among the Elderly

Completed

• Conditions: Spinal Injuries; Neck Injuries

• 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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-19
• Study First Submitted QC: 2005-12-19
• Study First Posted: 2005-12-20
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

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

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