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

This study has been completed.
Sponsor:
Collaborator:
AOSpine North America
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00283998
First received: January 30, 2006
Last updated: March 25, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Quality of life using the SF-36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of bony fusion between the two treatments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion rate of non-union between the two treatments [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cervical range of motion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Identify the risk factors for a poor outcome independent of treatment intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00283998     History of Changes
Other Study ID Numbers: 06-Odont-02
Study First Received: January 30, 2006
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014