Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
NCT ID: NCT02188836
Last Updated: 2022-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
64 participants
INTERVENTIONAL
2008-01-31
2010-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Electromagnetic device
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.
Electromagnetic stimulation
Electromagnetic stimulation with a new device produced by the investigators for this study.
Placebo device
A device with the same characteristics to the real device, except for the generation of the electromagnetic stimulation. It generates sham stimulation.
Sham stimulation
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.
Interventions
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Electromagnetic stimulation
Electromagnetic stimulation with a new device produced by the investigators for this study.
Sham stimulation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.
18 Years
60 Years
ALL
No
Sponsors
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Fundacion Clinica Valle del Lili
OTHER
Responsible Party
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Juan Pablo Martinez
Medical doctor
Principal Investigators
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Alfredo Martinez, MD
Role: PRINCIPAL_INVESTIGATOR
Fundacion Clinica Valle del Lili
Locations
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Fundacion Valle del Lili
Cali, Valle del Cauca Department, Colombia
Countries
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Other Identifiers
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FemurEMG
Identifier Type: -
Identifier Source: org_study_id
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