Clinical Trial: Treatment of Type II Odontoid Fractures Among the Elderly

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:

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.

Sponsor: AOSpine North America Research Network

Current Primary Outcome:

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


Original Primary Outcome:

Current Secondary Outcome:

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


Original Secondary Outcome:

Information By: AOSpine North America Research Network

Dates:
Date Received: December 19, 2005
Date Started: December 2005
Date Completion:
Last Updated: May 19, 2015
Last Verified: April 2015