Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Pulsed Electromagnetic Fields (Cervical-Stim®) as an Adjunct to Enhance Union in Conservatively Treated Type II Fractures of the Odontoid Process

Conditions
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Odontoid Fracture Type II

Intervention / Treatment
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* Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be 50 years of age or older at the time of consent Subject must have radiographic evidence (x-ray , MRI and CT scan) of a Type II odontoid fracture Subject must have MRI evidence that the fracture occurred within 30 days of study enrollment Subject must have VAS neck pain score of greater than 4 (>4) Subject must have radiographic evidence that the fracture is displaced ≤ 5 mm in any direction and/or have a fracture gap of ≤ 3 mm due to angulation Subject must use a rigid cervical collar (Miami J, Philadelphia or Aspen) for a minimum of three months post-injury Subject must have a DEXA scan within 6 months prior to enrollment (can be done within one week of baseline visit) Subject must be willing and able to follow all study procedures and return for all study visits Subject must be willing to sign an Informed Consent Document Exclusion Criteria: Subject has undergone systematic administration, within 30 days prior to the fracture, of any type of corticosteroid, antineoplastic, immunostimulation or immunosuppressive agents Subject is on chronic anticoagulation, or has a bleeding disorder Subject is pregnant, nursing or plans to become pregnant during the study Subject has a chronic Type II odontoid fracture that occurred more than 21 days prior to enrollment Subject has a Type II odontoid fracture displaced >5 mm Subject has a mental or physical condition that would prevent him from complying with the study protocol, including the physician obtaining an accurate neurologic exam Subject was recommended for surgery to treat the fracture but subject refused surgery Subject is a prisoner Subject has participated in another clinical trial within the last 90 days

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active PEMF<br>Active device emits Pulsed Electromagnetic Field (PEMF) | Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD<br>* Active devices emit PEMF signal; control devices do not emit PEMF signal.<br>|
| Placebo Comparator: Control/no PEMF<br>control/placebo device does not emit Pulsed Electromagnetic Field (PEMF) | Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD<br>* Active devices emit PEMF signal; control devices do not emit PEMF signal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change over time of VAS pain |  | Baseline, 6 week, 3 month, 6 month, 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEMF, IDE, odontoid fracture, prospective