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Treatment of Type II Odontoid Fractures Among the Elderly
This study is currently recruiting participants.
Study NCT00266929   Information provided by AO Clinical Investigation and Documentation
First Received: December 19, 2005   Last Updated: August 6, 2009   History of Changes

December 19, 2005
August 6, 2009
December 2005
April 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index
  • Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients
  • Compare the rate of non-union between the surgically and conservatively managed patients
Complete list of historical versions of study NCT00266929 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Compare the rate of complications
  • Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management
  • Identify risk factors for a poor outcome, independent of treatment intervention
 
Treatment of Type II Odontoid Fractures Among the Elderly
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.

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.
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
  • Neck Injuries
  • Spinal Injuries
  • Procedure: surgical
  • Procedure: conservative treatment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
166
August 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
64 Years and older
Yes
Contact: Branko Kopjar, MD 206-221-3349 brankok@u.washington.edu
United States
 
NCT00266929
Wynne Xie, NorConsult LLC
07-GOF-05
AO Clinical Investigation and Documentation
AOSpine North America
Principal Investigator: Alexander R Vaccaro, MD Thomas Jefferson University and The Rothman Institute
AO Clinical Investigation and Documentation
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP