Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

Fundacion Clinica Valle del Lili

Status and phase: Completed; Phase 3

Conditions: Fracture, Closed, Comminuted, Healing

Treatments: Device: Sham stimulation; Device: Electromagnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02188836

FemurEMG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Electromagnetic device

Experimental group

Description:

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.

Treatment:

Device: Electromagnetic stimulation

Placebo device

Placebo Comparator group

Description:

A device with the same characteristics to the real device, except for the generation of the electromagnetic stimulation. It generates sham stimulation.

Treatment:

Device: Sham stimulation