Orthofix Cervical Stim® Trial

Study Site Summary

This investigational device clinical study evaluates the use of pulsed electromagnetic fields (PEMF) technology in improving osteogenesis (bone growth) for Type II odontoid fractures. Specifically, this study examines the safety and effectiveness of PEMF treatment with the Orthofix Cervical-Stim® device as an adjunct to standard immobilization with a rigid collar.  The FDA approved Orthofix Cervical-Stim® device is a flexible, single-piece, integrated Control Unit and Transducer design powered by a rechargeable lithium-ion battery pack. A lift collar has been created to raise the coil approximately 3 inches to ensure that the fracture site receives the proper signal strength. The device can be worn on your shoulders with or without a rigid cervical collar.

Study Sites

  • Aspirus Spine and Neurosciences Institute
  • DISC Sports and Spine Center
  • Northwestern University
  • Oregon Health and Science University
  • OrthoCarolina Research Institute, Inc.
  • Texas Back Institute
  • University of California, Davis
  • University of California, San Francisco: Zuckerberg San Francisco General Hospital 
  • University of Colorado, Denver
  • University of Kanasas Hospital
  • University of Maryland
  • University of Michigan
  • Washington Neurosurgical Associates
  • Washington University School of Medicine
  • Yale University

What is involved?

  • Access to the patient's hospilitization records.
  • Patient will wear the device 4 hours a day for 6 months and keep a compliance diary. 
  • SF-36v2 Health Survey, NDI and Visual Analog Scale (VAS) pain questionnaires in hospital, 6 weeks, 3 months, 6 months, and 12 months post-injury. 
  • Neurological exams in hospital, 6 weeks, 3 months, 6 months, and 12 months post-injury. 
  • X-ray in hospital, 6 weeks, 3 months, 6 months, and 12 months post-injury. 
  • CT in hospital and 6 months post-injury.
  • MRI and DEXA scan in hospital. 
  • Device Compliance and Adverse Events Assessments at Day 2, 3 weeks, 6 weeks, 3 months, and 6 months.

Who can participate?

  • > 50 years of age
  • Radiographic evidence (x-ray , MRI and CT scan) of a Type II odontoid fracture
  • MRI evidence that the fracture occurred within 30 days of study enrollment
  • VAS neck pain score of greater than 4 (>4)
  • Radiographic evidence that the fracture is displaced ≤ 5 mm in any direction and/or have a fracture gap of ≤ 3 mm due to angulation
  • Use a rigid cervical collar (Miami J, Philadelphia or Aspen) for a minimum of three months post-injury
  • DEXA scan within 6 months prior to enrollment (can be done within one week of baseline visit)
  • Willing and able to follow all study procedures and return for all study visits
  • Willing to sign an Informed Consent Document