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Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields

Primary Purpose

Odontoid Fracture Type II

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Odontoid Fracture Type II focused on measuring PEMF, odontoid fracture, IDE, prospective

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active PEMF

Control/no PEMF

Arm Description

Active device emits Pulsed Electromagnetic Field (PEMF)

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

Outcomes

Primary Outcome Measures

Change over time of VAS pain

Secondary Outcome Measures

Full Information

NCT ID

NCT02281994

First Posted

October 26, 2014

Last Updated

October 25, 2021

Sponsor

Orthofix Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02281994

Brief Title

Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2019 (Actual)

Study Completion Date

September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Orthofix Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Odontoid Fracture Type II

Keywords

PEMF, odontoid fracture, IDE, prospective

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active PEMF

Arm Type

Active Comparator

Arm Description

Active device emits Pulsed Electromagnetic Field (PEMF)

Arm Title

Control/no PEMF

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Change over time of VAS pain

Time Frame

Baseline, 6 week, 3 month, 6 month, 12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: