| December 19, 2005 |
| August 6, 2009 |
| December 2005 |
| April 2010 (final data collection date for primary outcome measure) |
- 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 ]
|
- Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index
- Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients
- Compare the rate of non-union between the surgically and conservatively managed patients
|
| Complete list of historical versions of study NCT00266929 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Compare the rate of complications
- Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management
- Identify risk factors for a poor outcome, independent of treatment intervention
|
| |
| Treatment of Type II Odontoid Fractures Among the Elderly |
| Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly |
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. |
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.
|
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
- Neck Injuries
- Spinal Injuries
|
- Procedure: surgical
- Procedure: conservative treatment
|
| |
| |
| |
| Recruiting |
| 166 |
| August 2010 |
| April 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 64 Years and older |
| Yes |
|
|
| United States |
| |
| NCT00266929 |
| Wynne Xie, NorConsult LLC |
| 07-GOF-05 |
| AO Clinical Investigation and Documentation |
| AOSpine North America |
| Principal Investigator: |
Alexander R Vaccaro, MD |
Thomas Jefferson University and The Rothman Institute |
|
|
| AO Clinical Investigation and Documentation |
| August 2009 |