NCT00586170

A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures

A Prospective, Randomized, Double-Blind Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fractures: Effect on Clinical Outcome and Growth Factor Synthesis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Nonunion of Fracture of Fifth Metatarsal

Interventions

Type	Name	Description
DEVICE	EBI Bone Healing System	10 hours of treatment per day for up to 24 weeks
DEVICE	Placebo Device	10 hours of treatment per day for up to 24 weeks
PROCEDURE	Surgery	Open Reduction and Internal Fixation of the nonunion site

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-08-01
• Completion: 2012-08-01
• First posted: 2008-01-04
• Last updated: 2017-06-21
• Results posted: 2016-05-16

Locations

2 sites across 1 country: United States