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Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Orthofix Inc.
ClinicalTrials.gov Identifier:
NCT02281994
First received: October 26, 2014
Last updated: July 27, 2016
Last verified: November 2014
  Purpose
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 Intervention
Odontoid Fracture Type II
Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Orthofix Inc.:

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

Estimated Enrollment: 360
Study Start Date: September 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02281994

Sponsors and Collaborators
Orthofix Inc.
Investigators
Principal Investigator: Richard Guyer, MD Texas Back Institute
Principal Investigator: Paul Arnold, MD The University of Kansas Hospital
Principal Investigator: Bruce V. Darden, MD OrthoCarolina Research Institute, Inc.
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: Andrew Beaumont, MD Aspirus Spine and Neurosciences Institute
Principal Investigator: Kelly Banagan, MD University of Maryland
Principal Investigator: Paul Park, MD University of Michigan
Principal Investigator: Vikas Patel, MD University of Colorado, Denver
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
  More Information

Responsible Party: Orthofix Inc.
ClinicalTrials.gov Identifier: NCT02281994     History of Changes
Other Study ID Numbers: CP-1402ODFX 
Study First Received: October 26, 2014
Last Updated: July 27, 2016

Keywords provided by Orthofix Inc.:
PEMF
odontoid fracture
IDE
prospective

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on February 20, 2017