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The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing, compared with standard conservative care, in subjects 50 years of age and over diagnosed with Type II odontoid fractures, and this effect will be evident by 6 months post-injury. Subjects will be assessed for the presence of a Type II odontoid fracture by X-ray, MRI and CT scan. Subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active: placebo control) to either the active or control device for 4 hours a day for 6 months. X-rays will be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture healing process, with flexion-extension x-rays collected at 3, 6 and 12 months. A CT scan will be performed at 6 months to confirm healing. Quality of Life measures (SF-36, VAS neck pain scale, NDI) will be collected at all visits (6 weeks, 3, 6 and 12 months). Study subjects will receive either an active Orthofix Cervical-Stim Model 2205OD or an inactive (placebo) Orthofix Cervical-Stim Model 2205OD device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active PEMF | Active Comparator | Active device emits Pulsed Electromagnetic Field (PEMF) |
|
| Control/no PEMF | Placebo Comparator | control/placebo device does not emit Pulsed Electromagnetic Field (PEMF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD | Device | Active devices emit PEMF signal; control devices do not emit PEMF signal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change over time of VAS pain | Baseline, 6 week, 3 month, 6 month, 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Arnold, MD | The University of Kansas Hospital | Principal Investigator |
| Wellington Hsu, MD | Northwestern University | Principal Investigator |
| Zachary Ray, MD | Washington University School of Medicine | Principal Investigator |
| Khalid Abbed, MD | Yale University | Principal Investigator |
| Joshua Ammerman, MD | Washington Neurosurgical Associates | Principal Investigator |
| Jung Yoo, MD | Oregon Health and Science University | Principal Investigator |
| Kelly Banagan, MD | University of Maryland, College Park | Principal Investigator |
| Kee Kim, MD | UC Davis | Principal Investigator |
| Sanjay Dhall, MD | UC San Francisco | Principal Investigator |
| Amir Vokshoor, MD |
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| DISC Sports and Spine Center |
| Principal Investigator |