Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields

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

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.

Study Overview

• Status: Terminated
• Conditions: Odontoid Fracture Type II
• Intervention / Treatment: Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Orthofix Inc.
• Investigators: 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: Joshua Ammerman, MD, Washington Neurosurgical Associates; Principal Investigator: Jung Yoo, MD, Oregon Health and Science University; Principal Investigator: Kelly Banagan, MD, University of Maryland, College Park; 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

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: October 26, 2014
• First Submitted That Met QC Criteria: November 3, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: IDE; prospective; PEMF; odontoid fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: CP-1402ODFX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes