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History of Changes for Study: NCT02188836
Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
Latest version (submitted October 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 11, 2014 None (earliest Version on record)
2 October 18, 2022 Study Status, Study Design and Oversight
Comparison Format:

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Study NCT02188836
Submitted Date:  July 11, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: FemurEMG
Brief Title: Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
Official Title: Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2014
Overall Status: Completed
Study Start: January 2008
Primary Completion: October 2010 [Actual]
Study Completion: October 2010 [Actual]
First Submitted: June 27, 2014
First Submitted that
Met QC Criteria:
July 11, 2014
First Posted: July 14, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 11, 2014
Last Update Posted: July 14, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Fundacion Clinica Valle del Lili
Responsible Party: Principal Investigator
Investigator: Juan Pablo Martinez
Official Title: Medical doctor
Affiliation: Fundacion Clinica Valle del Lili
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Fracture, Closed, Comminuted, Healing
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 64 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • "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.
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Study Officials: Alfredo Martinez, MD
Principal Investigator
Fundacion Clinica Valle del Lili
Locations: Colombia, Valle
Fundacion Valle del Lili
Cali, Valle, Colombia
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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