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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electromagnetic device | Experimental | 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. |
|
| Placebo device | Placebo Comparator | A device with the same characteristics to the real device, except for the generation of the electromagnetic stimulation. It generates sham stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromagnetic stimulation | Device | Electromagnetic stimulation with a new device produced by the investigators for this study. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | Percentage (%) in each arm which may present an infection. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo Martinez, MD | Fundacion Clinica Valle del Lili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Valle del Lili | Cali | Valle del Cauca Department | Colombia |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D018460 | Fractures, Comminuted |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Electromagnetic device
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Sham electromagnetic device
| Sham stimulation | Device | 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. |
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