Treatment of Type II Odontoid Fractures Among the Elderly

This study has been completed.
Sponsor:
Collaborator:
AOSpine North America
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00266929
First received: December 19, 2005
Last updated: November 27, 2013
Last verified: November 2013
  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
Neck Injuries
Spinal Injuries
Procedure: surgical
Procedure: conservative treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly

Resource links provided by NLM:


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 ]

Enrollment: 159
Study Start Date: December 2005
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgical
Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation)
Procedure: surgical
surgical treatment of odontoid fractures
Non-surgical
Subjects treated with non-operative treatment options
Procedure: conservative treatment
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
Sampling Method:   Non-Probability Sample
Study Population

Subjects receiving care for acute Type II Odontoid Fracture in participating investigational sites

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00266929     History of Changes
Other Study ID Numbers: 07-GOF-05
Study First Received: December 19, 2005
Last Updated: November 27, 2013
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:
Spinal Injuries
Neck Injuries
Back Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 16, 2014