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Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

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ClinicalTrials.gov Identifier: NCT02188836
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Juan Pablo Martinez, Fundacion Clinica Valle del Lili

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.


Condition or disease Intervention/treatment Phase
Fracture, Closed, Comminuted, Healing Device: Electromagnetic stimulation Device: Sham stimulation Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial
Study Start Date : January 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


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 Name: "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.




Primary Outcome Measures :
  1. Fracture healing [ Time Frame: up to 18 weerks ]
    Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began.


Secondary Outcome Measures :
  1. Infection [ Time Frame: 6 months ]
    Percentage (%) in each arm which may present an infection.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188836


Locations
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Colombia
Fundacion Valle del Lili
Cali, Valle, Colombia
Sponsors and Collaborators
Fundacion Clinica Valle del Lili
Investigators
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Principal Investigator: Alfredo Martinez, MD Fundacion Clinica Valle del Lili
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Responsible Party: Juan Pablo Martinez, Medical doctor, Fundacion Clinica Valle del Lili
ClinicalTrials.gov Identifier: NCT02188836    
Other Study ID Numbers: FemurEMG
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Fractures, Closed
Wounds and Injuries
Leg Injuries