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Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188836
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : October 21, 2022
Sponsor:
Information provided by (Responsible Party):
Juan Pablo Martinez, Fundacion Clinica Valle del Lili

Tracking Information
First Submitted Date  ICMJE June 27, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date October 21, 2022
Study Start Date  ICMJE January 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Infection [ Time Frame: 6 months ]
Percentage (%) in each arm which may present an infection.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
Official Title  ICMJE Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Electromagnetic device
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sham electromagnetic device
Primary Purpose: Treatment
Condition  ICMJE Fracture, Closed, Comminuted, Healing
Intervention  ICMJE
  • Device: Electromagnetic stimulation
    Electromagnetic stimulation with a new device produced by the investigators for this study.
    Other Name: "Consolidator"
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Electromagnetic stimulation
  • 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.
    Intervention: Device: Sham stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2014)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188836
Other Study ID Numbers  ICMJE FemurEMG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Juan Pablo Martinez, Fundacion Clinica Valle del Lili
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fundacion Clinica Valle del Lili
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alfredo Martinez, MD Fundacion Clinica Valle del Lili
PRS Account Fundacion Clinica Valle del Lili
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP