A Double Blind Randomized Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fracture
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 5th Metatarsal Non Union Fracture
Intervention: EBI Bone Healing System (Device)
Phase: N/A
Status: Recruiting
Sponsored by: EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing Official(s) and/or principal investigator(s):
John Evangelsita, MD, Study Chair, Affiliation: EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Overall contact:
John Evangelista, MD, Phone: 973-299-9300, Ext: 3930, Email: john.evangelista@ebimed.com
Summary
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th
Metatarsal non-union Fractures.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Percentage of successful 5th metatarsal unions achieved.
Secondary outcome: Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline)
Detailed description:
The investigators hypothesize:
1. 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.
2. 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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subject has been diagnosed with a 5th metatarsal delayed or non-union.
2. Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
3. Male or female between ages of 18 and 75 years old, inclusive
Exclusion Criteria:
1. Subject has synovial pseudarthrosis.
2. Subject has a fracture gap of larger than 5mm as measured on CT Scan.
3. Subjects with conditions associated with elevated circulatory levels of inflammatory
cytokines e. g., multiple trauma.
4. If female, subject is pregnant, plans on becoming pregnant during the duration of
this clinical outcomes collection study or lactating.
5. Subject has an implanted unipolar pacemaker.
6. Subjects who have previous malignant or connective tissue disorder.
7. Subjects who use medication such as steroids or anticoagulants.
8. Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.
Locations and Contacts
John Evangelista, MD, Phone: 973-299-9300, Ext: 3930, Email: john.evangelista@ebimed.com
Neurological Institute of NJ, Newark, New Jersey 07103, United States; Recruiting
Joyce Kim, Phone: 973-972-7745, Email: kim17@umdnj.edu
Sheldon S Lin, MD, Principal Investigator
Wayne S Barberian, MD, Sub-Investigator
The Orthopedic Foot and Ankle Center, Columbus, Ohio 43231, United States; Recruiting
Elizabeth Blashock, Phone: 614-895-2552, Ext: 111, Email: blashockem@orthofootankle.com
Terrence Philbin, MD, Principal Investigator
Additional Information
Starting date: November 2007
Ending date: December 2010
Last updated: June 18, 2009
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