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Treatment of Type II Odontoid Fractures Among the Elderly

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ClinicalTrials.gov Identifier: NCT00266929
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : August 11, 2017
Sponsor:
Collaborator:
AOSpine North America
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Neck Injuries Spinal Injuries Procedure: surgical Procedure: conservative treatment

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 Type : Observational
Actual Enrollment : 159 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
Study Start Date : December 2005
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index [ Time Frame: 12 months ]
  2. Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients [ Time Frame: 12 months ]
  3. Compare the rate of non-union between the surgically and conservatively managed patients [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Compare the rate of complications [ Time Frame: 12 months ]
  2. Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management [ Time Frame: 12 months ]
  3. Identify risk factors for a poor outcome, independent of treatment intervention [ Time Frame: 12 months ]


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Ages Eligible for Study:   64 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
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
AOSpine North America Research Network
AOSpine North America
Investigators
Principal Investigator: Alexander R Vaccaro, MD Thomas Jefferson University and The Rothman Institute

Publications of Results:

Other Publications:
Responsible Party: AOSpine North America Research Network
ClinicalTrials.gov Identifier: NCT00266929     History of Changes
Other Study ID Numbers: 07-GOF-05
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Keywords provided by AOSpine North America Research Network:
odontoid fx
surgical intervention
conservative treatment
nonunion
odontoid fractures
surgical treatment

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Injuries
Neck Injuries
Back Injuries