Clinical Trial: Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Fundacion Clinica Valle del Lili

Current Primary Outcome: Fracture healing [ Time Frame: up to 18 weerks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Infection [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Fundacion Clinica Valle del Lili

Dates:
Date Received: June 27, 2014
Date Started: January 2008
Date Completion:
Last Updated: July 11, 2014
Last Verified: July 2014