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| Sponsors and Collaborators: |
AO Clinical Investigation and Documentation AOSpine North America |
| Information provided by: | AO Clinical Investigation and Documentation |
| ClinicalTrials.gov Identifier: | NCT00266929 |
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 > 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.
| Condition | Intervention | Phase |
|
Neck Injuries Spinal Injuries |
Procedure: surgical Procedure: conservative treatment |
Phase IV |
| MedlinePlus related topics: | Fractures Neck Injuries and Disorders |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly |
| Estimated Enrollment: | 166 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Hypotheses are as follows:
Eligibility
| Ages Eligible for Study: | 64 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Branko Kopjar, MD | 206-221-3349 | brankok@u.washington.edu |
| United States, Georgia | |||||
| Emory University SOM: Orthopedics | Recruiting | ||||
| Atlanta, Georgia, United States, 30329 | |||||
| Contact: Tim Yoon, MD, PhD 404-778-7160 | |||||
| Principal Investigator: Tim Yoon, MD, PhD | |||||
| United States, Pennsylvania | |||||
| Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| Contact: Alexander R Vaccaro, MD 267-339-3623 alexvaccaro3@aol.com | |||||
| Principal Investigator: Alexander R Vaccaro, MD | |||||
| AO Clinical Investigation and Documentation |
| AOSpine North America |
| Principal Investigator: | Alexander R Vaccaro, MD | Thomas Jefferson University and The Rothman Institute |
More Information
| Responsible Party: | AO Clinical Investigation of NA ( Judy He ) |
| Study ID Numbers: | 07-GOF-05 |
| First Received: | December 19, 2005 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00266929 |
| Health Authority: | United States: Institutional Review Board |
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