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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02188836
Study type Interventional
Source Fundacion Clinica Valle del Lili
Contact
Status Completed
Phase Phase 3
Start date January 2008
Completion date October 2010

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