Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields (NCT02281994) | Clinical Trial Compass
TerminatedNot Applicable
Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields
24 participantsStarted 2014-09
Plain-language summary
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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.