Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly

NCT ID: NCT00283998

Last Updated: 2014-03-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients \>/= 65 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

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Conditions

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Odontoid Fractures Type II

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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surgical versus conservative treatment

Surgical treatment of fractures versus conservative stabilization

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All new type II odontoid fractures including \< those in which the fracture line crosses into the body of C2 \< as long as it doesn't enter the superior articular process of C2
* Age 65+
* Stable and unstable fractures
* \< 3 months postinjury
* No previous treatment for an odontoid fracture

Exclusion Criteria

* Pathologic fractures unrelated to osteoporosis
* Severe dementia or other severe mental health problem if there is no consentable surrogate available
* Participating in other trials or unlikely to attend follow-ups
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AOSpine North America

INDUSTRY

Sponsor Role collaborator

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander R Vaccaro, MD

Role: PRINCIPAL_INVESTIGATOR

Th. Jefferson University Philadelphia

Locations

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Emory University SOM: Orthopedics

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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06-Odont-02

Identifier Type: -

Identifier Source: org_study_id

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