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

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

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.

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.