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Trial record 11 of 11 for:    aospine

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

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.
 
ClinicalTrials.gov Identifier: NCT00283998
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
AOSpine North America
Information provided by (Responsible Party):
AO Innovation Translation Center ( AO Clinical Investigation and Documentation )

Tracking Information
First Submitted Date  ICMJE January 30, 2006
First Posted Date  ICMJE January 31, 2006
Last Update Posted Date March 26, 2014
Study Start Date  ICMJE January 2006
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
  • - Quality of life using the Neck disability Index
  • - Quality of life using the SF-36
  • - Proportion of bony fusion between the two treatments
  • - Proportion rate of non-union between the two treatments
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
  • - Rate of complications
  • - Cervical range of motion
  • - Identify the risk factors for a poor outcome independent of treatment intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
Official Title  ICMJE Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures
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 >/= 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Odontoid Fractures Type II
Intervention  ICMJE Procedure: surgical versus conservative treatment
Surgical treatment of fractures versus conservative stabilization
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 16, 2007)
166
Original Enrollment  ICMJE
 (submitted: January 30, 2006)
150
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283998
Other Study ID Numbers  ICMJE 06-Odont-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AO Innovation Translation Center ( AO Clinical Investigation and Documentation )
Study Sponsor  ICMJE AO Clinical Investigation and Documentation
Collaborators  ICMJE AOSpine North America
Investigators  ICMJE
Principal Investigator: Alexander R Vaccaro, MD Th. Jefferson University Philadelphia
PRS Account AO Innovation Translation Center
Verification Date March 2014

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