<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02188836</url>
  </required_header>
  <id_info>
    <org_study_id>FemurEMG</org_study_id>
    <nct_id>NCT02188836</nct_id>
  </id_info>
  <brief_title>Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures</brief_title>
  <official_title>Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion Clinica Valle del Lili</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion Clinica Valle del Lili</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal&#xD;
      femur fractures using a device developed by the investigators.&#xD;
&#xD;
      The hypothesis is that patients with femoral diaphysis treated with the electromagnetic&#xD;
      stimulation have less non-union after six months than patients treated with a placebo device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The inclusion criteria were: patients of any sex, age between 18 and 60 years, with a closed&#xD;
      fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet;&#xD;
      treated with open or closed reduction and intramedullary reamed blocked nail.&#xD;
&#xD;
      Patients were excluded if they had a pathological fracture, an open fracture from another&#xD;
      etiology, or if they were treated after 10 days from the day of fracture.&#xD;
&#xD;
      64 patients were included.&#xD;
&#xD;
      Randomization took place six weeks after fracture day, allocating participants to either one&#xD;
      of two groups: group A (electromagnetic stimulation) or group B (placebo).&#xD;
&#xD;
      Each group had a device exactly the same. Patients used the device during one hour every day&#xD;
      for eight weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">October 2010</completion_date>
  <primary_completion_date type="Actual">October 2010</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Electromagnetic device</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Sham electromagnetic device</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fracture healing</measure>
    <time_frame>up to 18 weerks</time_frame>
    <description>Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage (%) in each arm which may present an infection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Fracture, Closed, Comminuted, Healing</condition>
  <arm_group>
    <arm_group_label>Electromagnetic device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo device</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A device with the same characteristics to the real device, except for the generation of the electromagnetic stimulation. It generates sham stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electromagnetic stimulation</intervention_name>
    <description>Electromagnetic stimulation with a new device produced by the investigators for this study.</description>
    <arm_group_label>Electromagnetic device</arm_group_label>
    <other_name>&quot;Consolidator&quot;</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham stimulation</intervention_name>
    <description>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.</description>
    <arm_group_label>Placebo device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of any sex,&#xD;
&#xD;
          -  age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an&#xD;
             open fracture secondary to a low-speed bullet;&#xD;
&#xD;
          -  treated with open or closed reduction and intramedullary reamed blocked nail.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were excluded if they had a pathological fracture,&#xD;
&#xD;
          -  an open fracture from another etiology, or if they were treated after 10 days from the&#xD;
             day of fracture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alfredo Martinez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundacion Clinica Valle del Lili</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fundacion Valle del Lili</name>
      <address>
        <city>Cali</city>
        <state>Valle</state>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Clinica Valle del Lili</investigator_affiliation>
    <investigator_full_name>Juan Pablo Martinez</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</mesh_term>
    <mesh_term>Fractures, Closed</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02188836
org study id: FemurEMG
nct id: NCT02188836
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Electromagnetic device
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Sham electromagnetic device
measure: Fracture healing
time frame: up to 18 weerks
description: Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began.
measure: Infection
time frame: 6 months
description: Percentage (%) in each arm which may present an infection.
arm group label: Electromagnetic device
arm group type: Experimental
description: 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.
arm group label: Placebo device
arm group type: Placebo Comparator
description: A device with the same characteristics to the real device, except for the generation of the electromagnetic stimulation. It generates sham stimulation.
intervention type: Device
intervention name: Electromagnetic stimulation
description: Electromagnetic stimulation with a new device produced by the investigators for this study.
arm group label: Electromagnetic device
other name: "Consolidator"
intervention type: Device
intervention name: Sham stimulation
description: 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.
arm group label: Placebo device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Alfredo Martinez, MD
role: Principal Investigator
affiliation: Fundacion Clinica Valle del Lili
facility: 
country: Colombia
responsible party type: Principal Investigator
investigator affiliation: Fundacion Clinica Valle del Lili
investigator full name: Juan Pablo Martinez
investigator title: Medical doctor
mesh term: Fractures, Bone
mesh term: Femoral Fractures
mesh term: Fractures, Closed