Status:
TERMINATED
Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields
Lead Sponsor:
Orthofix Inc.
Conditions:
Odontoid Fracture Type II
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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 odonto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02281994
Start Date
September 1 2014
End Date
September 1 2019
Last Update
October 26 2021
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