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Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

NCT02188836 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-10-21

No results posted yet for this study

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

Interventions

DEVICE

Electromagnetic stimulation

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

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.

Sponsors & Collaborators

  • Fundacion Clinica Valle del Lili

    lead OTHER

Principal Investigators

  • Alfredo Martinez, MD · Fundacion Clinica Valle del Lili

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02188836 on ClinicalTrials.gov