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Completed

NCT Number: NCT02188836

Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

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.

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Key information

Conditions

Fracture, Closed, Comminuted, Healing Fractures, Bone Fractures, Comminuted Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

electromagnetic stimulation

Device

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

Other names: "Consolidator"

Sham stimulation

Device

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 outcomes

  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 outcomes

  1. Infection

    Time frame: 6 months

    Percentage (%) in each arm which may present an infection.

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Valle del Lili

Other

Registry information

Official study title

Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 14, 2014
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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