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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02188836
Other study ID # FemurEMG
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2008
Est. completion date October 2010

Study information

Verified date October 2022
Source Fundacion Clinica Valle del Lili
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Electromagnetic stimulation
Electromagnetic stimulation with a new device produced by the investigators for this study.
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.

Locations

Country Name City State
Colombia Fundacion Valle del Lili Cali Valle

Sponsors (1)

Lead Sponsor Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fracture healing Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began. up to 18 weerks
Secondary Infection Percentage (%) in each arm which may present an infection. 6 months
See also
  Status Clinical Trial Phase
Completed NCT02256059 - Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension N/A
Completed NCT01386749 - Effect of Low-Magnitude, High Frequency Vibration Treatment on Femoral Shaft Fracture Healing Phase 2/Phase 3