Treatment of Type II Odontoid Fractures Among the Elderly - Full Text View

Sponsor:	AO Clinical Investigation and Documentation
Collaborator:	AOSpine North America
Information provided by:	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT00266929

Purpose

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.

Condition	Intervention	Phase
Neck Injuries Spinal Injuries	Procedure: surgical Procedure: conservative treatment	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly

Resource links provided by NLM:

MedlinePlus related topics: Fractures Neck Injuries and Disorders

U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:

Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Compare the rate of non-union between the surgically and conservatively managed patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the rate of complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Identify risk factors for a poor outcome, independent of treatment intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	166
Study Start Date:	December 2005
Study Completion Date:	March 2011
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

surgical treatment of odontoid fractures

conservative stabilization of 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

Ages Eligible for Study:	64 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266929

Locations

United States, Georgia
Emory University SOM: Orthopedics
Atlanta, Georgia, United States, 30329
United States, Indiana
Indiana Spine Group
Indianapolis, Indiana, United States, 46260
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21287
Mayo Clinic
Rochester, Maryland, United States, 55905
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Cornell Weill Medical College
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States
United States, Pennsylvania
Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 258

Sponsors and Collaborators

AO Clinical Investigation and Documentation

AOSpine North America

Investigators

Principal Investigator:

Alexander R Vaccaro, MD

Thomas Jefferson University and The Rothman Institute

More Information

No publications provided

Responsible Party:	Wynne Xie, NorConsult LLC
ClinicalTrials.gov Identifier:	NCT00266929 History of Changes
Other Study ID Numbers:	07-GOF-05
Study First Received:	December 19, 2005
Last Updated:	April 18, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by AO Clinical Investigation and Documentation:

odontoid fx
surgical intervention
conservative treatment

nonunion
odontoid fractures
surgical treatment

Additional relevant MeSH terms:

Neck Injuries
Spinal Injuries
Wounds and Injuries
Back Injuries

ClinicalTrials.gov processed this record on February 09, 2012