Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields

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.

Conditions

• Odontoid Fracture Type II

Interventions

DEVICE

Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD

Active devices emit PEMF signal; control devices do not emit PEMF signal.

Sponsors & Collaborators

• Orthofix Inc.

  lead INDUSTRY

Principal Investigators

• Paul Arnold, MD · The University of Kansas Hospital

• Wellington Hsu, MD · Northwestern University

• Zachary Ray, MD · Washington University School of Medicine

• Khalid Abbed, MD · Yale University

• Joshua Ammerman, MD · Washington Neurosurgical Associates

• Jung Yoo, MD · Oregon Health and Science University

• Kelly Banagan, MD · University of Maryland, College Park

• Kee Kim, MD · UC Davis

• Sanjay Dhall, MD · UC San Francisco

• Amir Vokshoor, MD · DISC Sports and Spine Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2019-09-30

Completion

2019-09-30

FDA Device

Yes