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| Name | Class |
|---|---|
| AOSpine North America | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical | Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation) |
| |
| Non-surgical | Subjects treated with non-operative treatment options |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical | Procedure | surgical treatment of odontoid fractures |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index | 12 months | |
| Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients | 12 months | |
| Compare the rate of non-union between the surgically and conservatively managed patients | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the rate of complications | 12 months | |
| Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects receiving care for acute Type II Odontoid Fracture in participating investigational sites
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| Name | Affiliation | Role |
|---|---|---|
| Alexander R Vaccaro, MD | Thomas Jefferson University and The Rothman Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University SOM: Orthopedics | Atlanta | Georgia | 30329 | United States | ||
| Indiana Spine Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19057244 | Background | Smith HE, Kerr SM, Maltenfort M, Chaudhry S, Norton R, Albert TJ, Harrop J, Hilibrand AS, Anderson DG, Kopjar B, Brodke DS, Wang JC, Fehlings MG, Chapman JR, Patel A, Arnold PM, Vaccaro AR. Early complications of surgical versus conservative treatment of isolated type II odontoid fractures in octogenarians: a retrospective cohort study. J Spinal Disord Tech. 2008 Dec;21(8):535-9. doi: 10.1097/BSD.0b013e318163570b. | |
| 19292388 |
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| conservative treatment |
| Procedure |
conservative stabilization of fractures |
|
| Identify risk factors for a poor outcome, independent of treatment intervention |
| 12 months |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| John Hopkins University | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Cornell Weill Medical College | New York | New York | 10021 | United States |
| Cleveland Clinic | Cleveland | Ohio | United States |
| Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Toronto Western Hospital | Toronto | Ontario | M5T 258 | Canada |
| Background |
| Smith HE, Vaccaro AR, Maltenfort M, Albert TJ, Hilibrand AS, Anderson DG, Harrop J, Fehlings MG, Kopjar B, Brodke DS, Arnold PM, Shaffrey CI. Trends in surgical management for type II odontoid fracture: 20 years of experience at a regional spinal cord injury center. Orthopedics. 2008 Jul;31(7):650. |
| 23595072 | Result | Vaccaro AR, Kepler CK, Kopjar B, Chapman J, Shaffrey C, Arnold P, Gokaslan Z, Brodke D, France J, Dekutoski M, Sasso R, Yoon ST, Bono C, Harrop J, Fehlings MG. Functional and quality-of-life outcomes in geriatric patients with type-II dens fracture. J Bone Joint Surg Am. 2013 Apr 17;95(8):729-35. doi: 10.2106/JBJS.K.01636. |
| 23459135 | Result | Fehlings MG, Arun R, Vaccaro AR, Arnold PM, Chapman JR, Kopjar B. Predictors of treatment outcomes in geriatric patients with odontoid fractures: AOSpine North America multi-centre prospective GOF study. Spine (Phila Pa 1976). 2013 May 15;38(11):881-6. doi: 10.1097/BRS.0b013e31828314ee. |
| 23354104 | Result | Chapman J, Smith JS, Kopjar B, Vaccaro AR, Arnold P, Shaffrey CI, Fehlings MG. The AOSpine North America Geriatric Odontoid Fracture Mortality Study: a retrospective review of mortality outcomes for operative versus nonoperative treatment of 322 patients with long-term follow-up. Spine (Phila Pa 1976). 2013 Jun 1;38(13):1098-104. doi: 10.1097/BRS.0b013e318286f0cf. |
| 20940632 | Result | Smith HE, Kerr SM, Fehlings MG, Chapman J, Maltenfort M, Zavlasky J, Harris E, Albert TJ, Harrop J, Hilibrand AS, Anderson DG, Vaccaro AR. Trends in epidemiology and management of type II odontoid fractures: 20-year experience at a model system spine injury tertiary referral center. J Spinal Disord Tech. 2010 Dec;23(8):501-5. doi: 10.1097/BSD.0b013e3181cc43c7. |
| 24335630 | Result | Smith JS, Kepler CK, Kopjar B, Harrop JS, Arnold P, Chapman JR, Fehlings MG, Vaccaro AR, Shaffrey CI. Effect of type II odontoid fracture nonunion on outcome among elderly patients treated without surgery: based on the AOSpine North America geriatric odontoid fracture study. Spine (Phila Pa 1976). 2013 Dec 15;38(26):2240-6. doi: 10.1097/BRS.0000000000000009. |
| ID | Term |
|---|---|
| D019838 | Neck Injuries |
| D013124 | Spinal Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D019567 | Back Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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