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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Nonunion of Fracture of Fifth Metatarsal

Intervention / Treatment
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* Device: EBI Bone Healing System
* Device: Placebo Device
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has been diagnosed with a 5th metatarsal delayed or non-union. Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months. Male or female between ages of 18 and 75 years old, inclusive 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBI Bone Healing System + Surgery<br>Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site. | Device: EBI Bone Healing System<br>* 10 hours of treatment per day for up to 24 weeks<br>Procedure: Surgery<br>* Open Reduction and Internal Fixation of the nonunion site<br>|
| Placebo Comparator: Placebo Device + Surgery<br>Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site. | Device: Placebo Device<br>* 10 hours of treatment per day for up to 24 weeks<br>Procedure: Surgery<br>* Open Reduction and Internal Fixation of the nonunion site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Successful 5th Metatarsal Unions Achieved. | Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing. | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline) |  | 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nonunion, fracture