Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02281994
Recruitment Status : Active, not recruiting
First Posted : November 4, 2014
Last Update Posted : October 19, 2018
Information provided by (Responsible Party):
Orthofix Inc.

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.

Condition or disease Intervention/treatment Phase
Odontoid Fracture Type II Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Active PEMF
Active device emits Pulsed Electromagnetic Field (PEMF)
Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD
Active devices emit PEMF signal; control devices do not emit PEMF signal.

Placebo Comparator: Control/no PEMF
control/placebo device does not emit Pulsed Electromagnetic Field (PEMF)
Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD
Active devices emit PEMF signal; control devices do not emit PEMF signal.

Primary Outcome Measures :
  1. Change over time of VAS pain [ Time Frame: Baseline, 6 week, 3 month, 6 month, 12 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02281994

Sponsors and Collaborators
Orthofix Inc.
Principal Investigator: 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
Principal Investigator: Kee Kim, MD UC Davis
Principal Investigator: Sanjay Dhall, MD UC San Francisco
Principal Investigator: Amir Vokshoor, MD DISC Sports and Spine Center

Responsible Party: Orthofix Inc. Identifier: NCT02281994     History of Changes
Other Study ID Numbers: CP-1402ODFX
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Orthofix Inc.:
odontoid fracture

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries