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Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields

NCT ID: NCT02281994

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-09-30

Brief Summary

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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

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Conditions

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Odontoid Fracture Type II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active PEMF

Active device emits Pulsed Electromagnetic Field (PEMF)

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Control/no PEMF

control/placebo device does not emit Pulsed Electromagnetic Field (PEMF)

Group Type PLACEBO_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orthofix Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Arnold, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Kansas Hospital

Wellington Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Zachary Ray, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Khalid Abbed, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Joshua Ammerman, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Neurosurgical Associates

Jung Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Kelly Banagan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Kee Kim, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Sanjay Dhall, MD

Role: PRINCIPAL_INVESTIGATOR

UC San Francisco

Amir Vokshoor, MD

Role: PRINCIPAL_INVESTIGATOR

DISC Sports and Spine Center

Other Identifiers

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CP-1402ODFX

Identifier Type: -

Identifier Source: org_study_id