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

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.

Study Overview

• Status: Completed
• Conditions: Fracture, Closed, Comminuted, Healing
• Intervention / Treatment: Device: Electromagnetic stimulation; Device: Sham stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Valle
    • Cali, Valle, Colombia
      • Fundacion Valle del Lili

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: "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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection	Percentage (%) in each arm which may present an infection.	6 months

Collaborators and Investigators

• Sponsor: Fundacion Clinica Valle del Lili
• Investigators: Principal Investigator: Alfredo Martinez, MD, Fundacion Clinica Valle del Lili

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 14, 2014

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone; Fractures, Closed
• Other Study ID Numbers: FemurEMG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No