Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

Fracture, Closed, Comminuted, Healing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188836
• Other study ID #: FemurEMG
• Status: Completed
• Phase: Phase 3
• Start date: January 2008
• Est. completion date: October 2010

Study information

• Verified date: October 2022
• Source: Fundacion Clinica Valle del Lili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Fracture, Closed, Comminuted, Healing
• Fractures, Bone
• Fractures, Closed

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Colombia	Fundacion Valle del Lili	Cali	Valle

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture healing	Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began.	up to 18 weerks
Secondary	Infection	Percentage (%) in each arm which may present an infection.	6 months