Treatment of Type II Odontoid Fractures Among the Elderly

August 9, 2017 updated by: AOSpine North America Research Network

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

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.

Study Overview

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

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

64 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical
Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation)
surgical treatment of odontoid fractures
Non-surgical
Subjects treated with non-operative treatment options
conservative stabilization of fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index
Time Frame: 12 months
12 months
Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients
Time Frame: 12 months
12 months
Compare the rate of non-union between the surgically and conservatively managed patients
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Alexander R Vaccaro, MD, Thomas Jefferson University and The Rothman Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 19, 2005

First Submitted That Met QC Criteria

December 19, 2005

First Posted (Estimate)

December 20, 2005

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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