Back to resultsElectromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
Primary Purpose
Fracture, Closed, Comminuted, Healing
Status
Completed
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Electromagnetic stimulation
Sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Fracture, Closed, Comminuted, Healing
Eligibility 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.
Sites / Locations
- Fundacion Valle del Lili
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Electromagnetic device
Placebo device
Arm 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.
A device with the same characteristics to the real device, except for the generation of the electromagnetic stimulation. It generates sham stimulation.
Outcomes
Primary Outcome Measures
Fracture healing
Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began.
Secondary Outcome Measures
Infection
Percentage (%) in each arm which may present an infection.
Full Information
NCT ID
NCT02188836
First Posted
June 27, 2014
Last Updated
October 18, 2022
Sponsor
Fundacion Clinica Valle del Lili
1. Study Identification
Unique Protocol Identification Number
NCT02188836
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinica Valle del Lili
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Closed, Comminuted, Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Electromagnetic device
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sham electromagnetic device
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electromagnetic device
Arm Type
Experimental
Arm 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 Title
Placebo device
Arm Type
Placebo Comparator
Arm 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(s)
Electromagnetic stimulation
Other Intervention Name(s)
"Consolidator"
Intervention Description
Electromagnetic stimulation with a new device produced by the investigators for this study.
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention 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.
Primary Outcome Measure Information:
Title
Fracture healing
Description
Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began.
Time Frame
up to 18 weerks
Secondary Outcome Measure Information:
Title
Infection
Description
Percentage (%) in each arm which may present an infection.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo Martinez, MD
Organizational Affiliation
Fundacion Clinica Valle del Lili
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Valle del Lili
City
Cali
State/Province
Valle
Country
Colombia
12. IPD Sharing Statement
Learn more about this trial
Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
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