A Double Blind Randomized Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fracture

This study is currently recruiting participants.

Verified by Biomet, Inc., February 2010

First Received: December 21, 2007 Last Updated: February 2, 2010 History of Changes

Sponsor:	EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00586170

Purpose

The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th Metatarsal non-union Fractures.

Condition	Intervention
5th Metatarsal Non Union Fracture	Device: EBI Bone Healing System

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double Blind Randomized Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fracture: Effect on Clinical Outcome and Growth Factor Synthesis

Resource links provided by NLM:

MedlinePlus related topics: Electromagnetic Fields Fractures

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Percentage of successful 5th metatarsal unions achieved. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Device: EBI Bone Healing System 10 hours of treatment per day for up to 24 weeks
2: Placebo Comparator	Device: EBI Bone Healing System 10 hours of treatment per day for up to 24 weeks

Detailed Description:

The investigators hypothesize:

That treatment of 5th metatarsal non-union fracture with PEMF will achieve earlier resolution and/or higher success compared to surgery alone of 5th metatarsal non-union fractures.
PEMF will stimulate increased expression of critical growth factors (i.e. BMP-2, BMP-4, BMP-7 as well as TGFb, IGF-1, FGF-2 and VEGF) at the non-union site to facilitate osseous healing of 5th Metatarsal Non-union Fractures.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has been diagnosed with a 5th metatarsal delayed or non-union.
Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
Male or female between ages of 18 and 75 years old, inclusive

Exclusion Criteria:

Subject has synovial pseudarthrosis.
Subject has a fracture gap of larger than 5mm as measured on CT Scan.
Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma.
If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
Subject has an implanted unipolar pacemaker.
Subjects who have previous malignant or connective tissue disorder.
Subjects who use medication such as steroids or anticoagulants.
Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586170

Contacts

Contact: John Evangelista, MD

973-299-9300 ext 3930

john.evangelista@ebimed.com

Locations

United States, New Jersey
Neurological Institute of NJ	Recruiting
Newark, New Jersey, United States, 07103
Contact: Swaroopa Vaidya 973-972-7745 swaroopa.vaidya@umdnj.edu
Principal Investigator: Sheldon S Lin, MD
Sub-Investigator: Wayne S Barberian, MD
United States, Ohio
The Orthopedic Foot and Ankle Center	Recruiting
Columbus, Ohio, United States, 43231
Contact: Emily Stansbury 614-895-2552 ext 111 stansburyet@orthofootankle.com
Principal Investigator: Terrence Philbin, MD

Sponsors and Collaborators

EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing

Investigators

Study Chair:

John Evangelsita, MD

EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing

More Information

No publications provided

Responsible Party:	EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing ( Betsy Lowry, Supervisor Clinical Data, CRA )
Study ID Numbers:	CS-027
Study First Received:	December 21, 2007
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00586170 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

non union
fracture

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on February 08, 2010