Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields

Not Applicable

Terminated

• Conditions: Odontoid Fracture Type II
• Interventions: Device: Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD

• Registration Number: NCT02281994
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-26
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control/no PEMF	Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD	control/placebo device does not emit Pulsed Electromagnetic Field (PEMF)
Active PEMF	Pulsed Electromagnetic Feld (PEMF) Orthofix Cervical-Stim Model 2205OD	Active device emits Pulsed Electromagnetic Field (PEMF)

Primary Outcome Measures

Name	Time	Method
Change over time of VAS pain	Baseline, 6 week, 3 month, 6 month, 12 month