Clinical trial NCT02281994: Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Odontoid Fracture Type II
Keywords: PEMF
odontoid fracture
IDE
prospective
Lead sponsor: Orthofix Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change over time of VAS pain
timeFrame: Baseline, 6 week, 3 month, 6 month, 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Kansas Hospital
name: Paul Arnold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Wellington Hsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Zachary Ray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Khalid Abbed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington Neurosurgical Associates
name: Joshua Ammerman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Jung Yoo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, College Park
name: Kelly Banagan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis
name: Kee Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC San Francisco
name: Sanjay Dhall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DISC Sports and Spine Center
name: Amir Vokshoor, MD
role: PRINCIPAL_INVESTIGATOR
References: