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

This study has been terminated.

( Slow enrollment )

First Received on December 21, 2007. Last Updated on November 1, 2011 History of Changes

Sponsor:	EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Information provided by (Responsible Party):	Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
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 ]

Enrollment:	9
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2012
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

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

Criteria

Inclusion Criteria:

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

Locations

United States, New Jersey
Neurological Institute of NJ
Newark, New Jersey, United States, 07103
United States, Ohio
The Orthopedic Foot and Ankle Center
Columbus, Ohio, United States, 43231

Sponsors and Collaborators

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

Investigators

Study Chair:

Betsy Lowry, CCRP

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

More Information

No publications provided

Responsible Party:	Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier:	NCT00586170 History of Changes
Other Study ID Numbers:	CS-027
Study First Received:	December 21, 2007
Last Updated:	November 1, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

non union
fracture

Additional relevant MeSH terms:

Fractures, Bone
Fractures, Ununited
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2012