Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
|ClinicalTrials.gov Identifier: NCT02188836|
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Fracture, Closed, Comminuted, Healing||Device: Electromagnetic stimulation Device: Sham stimulation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Experimental: 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.
Device: Electromagnetic stimulation
Electromagnetic stimulation with a new device produced by the investigators for this study.
Other Name: "Consolidator"
Placebo Comparator: Placebo device
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
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.
- Fracture healing [ Time Frame: up to 18 weerks ]Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began.
- Infection [ Time Frame: 6 months ]Percentage (%) in each arm which may present an infection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188836
|Fundacion Valle del Lili|
|Cali, Valle, Colombia|
|Principal Investigator:||Alfredo Martinez, MD||Fundacion Clinica Valle del Lili|