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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283998
First Posted: January 31, 2006
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AOSpine North America
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
  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 >/= 65 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 Phase
Odontoid Fractures Type II Procedure: surgical versus conservative treatment Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Quality of life using the Neck disability Index [ Time Frame: 12 months ]
  • Quality of life using the SF-36 [ Time Frame: 12 months ]
  • Proportion of bony fusion between the two treatments [ Time Frame: 6 months ]
  • Proportion rate of non-union between the two treatments [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Rate of complications [ Time Frame: 12 months ]
  • Cervical range of motion [ Time Frame: 12 months ]
  • Identify the risk factors for a poor outcome independent of treatment intervention [ Time Frame: 12 months ]

Estimated Enrollment: 166
Study Start Date: January 2006
Study Completion Date: March 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: surgical versus conservative treatment
    Surgical treatment of fractures versus conservative stabilization
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All new type II odontoid fractures including < those in which the fracture line crosses into the body of C2 < as long as it doesn't enter the superior articular process of C2
  • Age 65+
  • Stable and unstable fractures
  • < 3 months postinjury
  • No previous treatment for an odontoid fracture

Exclusion Criteria:

  • Pathologic fractures unrelated to osteoporosis
  • Severe dementia or other severe mental health problem if there is no consentable surrogate available
  • Participating in other trials or unlikely to attend follow-ups
  Contacts and Locations
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): NCT00283998


Locations
United States, Georgia
Emory University SOM: Orthopedics
Atlanta, Georgia, United States, 35037
Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOSpine North America
Investigators
Principal Investigator: Alexander R Vaccaro, MD Th. Jefferson University Philadelphia
  More Information

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00283998     History of Changes
Other Study ID Numbers: 06-Odont-02
First Submitted: January 30, 2006
First Posted: January 31, 2006
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by AO Clinical Investigation and Documentation:
Odontoid
Type II fractures
Elderly patients
Surgical vs. conservative treatment

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries