Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

NCT02188836 | Completed Phase 3 DMC

• 1 other identifier: FemurEMG
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture, Closed, Comminuted, Healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Infection

  6 months

Study Arms (2)

Electromagnetic device

EXPERIMENTAL

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

Placebo device

PLACEBO COMPARATOR

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

Interventions

Electromagnetic stimulation DEVICE

Electromagnetic stimulation with a new device produced by the investigators for this study.

Also known as: "Consolidator"

Electromagnetic device

Sham stimulation DEVICE

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.

Placebo device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

Study Sites (1)

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Location

MeSH Terms

Conditions

Fractures, Bone; Fractures, Comminuted

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Alfredo Martinez, MD

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham electromagnetic device
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: Electromagnetic device

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 14, 2014
• Study Start: January 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

CO (1)