Treatment of Type II Odontoid Fractures Among the Elderly
This study has been completed.
Sponsor:
AO Clinical Investigation and Documentation
Collaborator:
AOSpine North America
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00266929
First received: December 19, 2005
Last updated: April 11, 2013
Last verified: April 2013
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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 |
|---|---|
|
Neck Injuries Spinal Injuries |
Procedure: surgical Procedure: conservative treatment |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly |
Resource links provided by NLM:
Further study details as provided by AO Clinical Investigation and Documentation:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 159 |
| Study Start Date: | December 2005 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Surgical
Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation)
|
Procedure: surgical
surgical treatment of odontoid fractures
|
|
Non-surgical
Subjects treated with non-operative treatment options
|
Procedure: conservative treatment
conservative stabilization of fractures
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 64 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects receiving care for acute Type II Odontoid Fracture in participating investigational sites
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266929
Locations
| United States, Georgia | |
| Emory University SOM: Orthopedics | |
| Atlanta, Georgia, United States, 30329 | |
| United States, Indiana | |
| Indiana Spine Group | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| Kansas University Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Maryland | |
| John Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| Mayo Clinic | |
| Rochester, Maryland, United States, 55905 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Cornell Weill Medical College | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States | |
| United States, Pennsylvania | |
| Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| United States, West Virginia | |
| West Virginia University | |
| Morgantown, West Virginia, United States, 26506 | |
| Canada, Ontario | |
| Toronto Western Hospital | |
| Toronto, Ontario, Canada, M5T 258 | |
Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOSpine North America
Investigators
| Principal Investigator: | Alexander R Vaccaro, MD | Thomas Jefferson University and The Rothman Institute |
More Information
No publications provided
| Responsible Party: | AO Clinical Investigation and Documentation |
| ClinicalTrials.gov Identifier: | NCT00266929 History of Changes |
| Other Study ID Numbers: | 07-GOF-05 |
| Study First Received: | December 19, 2005 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by AO Clinical Investigation and Documentation:
|
odontoid fx surgical intervention conservative treatment |
nonunion odontoid fractures surgical treatment |
Additional relevant MeSH terms:
|
Neck Injuries Spinal Injuries Wounds and Injuries Back Injuries |
ClinicalTrials.gov processed this record on May 21, 2013