Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

Study Overview
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Brief Summary
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This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal femur fractures using a device developed by the investigators. The hypothesis is that patients with femoral diaphysis treated with the electromagnetic stimulation have less non-union after six months than patients treated with a placebo device.

Detailed Description
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The inclusion criteria were: patients of any sex, age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet; treated with open or closed reduction and intramedullary reamed blocked nail. Patients were excluded if they had a pathological fracture, an open fracture from another etiology, or if they were treated after 10 days from the day of fracture. 64 patients were included. Randomization took place six weeks after fracture day, allocating participants to either one of two groups: group A (electromagnetic stimulation) or group B (placebo). Each group had a device exactly the same. Patients used the device during one hour every day for eight weeks.

Official Title
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Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial

Conditions
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Fracture, Closed, Comminuted, Healing

Intervention / Treatment
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* Device: Electromagnetic stimulation
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of any sex, age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet; treated with open or closed reduction and intramedullary reamed blocked nail. Exclusion Criteria: Patients were excluded if they had a pathological fracture, an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: Electromagnetic device
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electromagnetic device<br>The electromagnetic stimulation was performed by using a device capable of generating an electromagnetic field around the fracture site. This was applied once a day, one hour for 8 weeks. | Device: Electromagnetic stimulation<br>* Electromagnetic stimulation with a new device produced by the investigators for this study.<br>* Other names: Consolidator;|
| Placebo Comparator: Placebo device<br>A device with the same characteristics to the real device, except for the generation of the electromagnetic stimulation. It generates sham stimulation. | Device: Sham stimulation<br>* This is a device that look exactly the same to the electrostimulation device, but that does not generate the electromagnetic field. It is a placebo device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture healing | Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began. | up to 18 weerks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Percentage (%) in each arm which may present an infection. | 6 months |