A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures
NCT ID: NCT00586170
Last Updated: 2017-06-21
Study Results
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View full resultsBasic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2007-11-30
2012-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EBI Bone Healing System + Surgery
Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
EBI Bone Healing System
10 hours of treatment per day for up to 24 weeks
Surgery
Open Reduction and Internal Fixation of the nonunion site
Placebo Device + Surgery
Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Placebo Device
10 hours of treatment per day for up to 24 weeks
Surgery
Open Reduction and Internal Fixation of the nonunion site
Interventions
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EBI Bone Healing System
10 hours of treatment per day for up to 24 weeks
Placebo Device
10 hours of treatment per day for up to 24 weeks
Surgery
Open Reduction and Internal Fixation of the nonunion site
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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John Evangelista
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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Neurological Institute of NJ
Newark, New Jersey, United States
The Orthopedic Foot and Ankle Center
Columbus, Ohio, United States
Countries
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Other Identifiers
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CS-027
Identifier Type: -
Identifier Source: org_study_id
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