NCT02188836

Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Fundacion Clinica Valle del Lili · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Fracture, Closed, Comminuted, Healing

Interventions

Type	Name	Description
DEVICE	Electromagnetic stimulation	Electromagnetic stimulation with a new device produced by the investigators for this study.
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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2014-07-14
• Last updated: 2022-10-21

Locations

1 site across 1 country: Colombia