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Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

Phase 3
Completed
Conditions
Fracture, Closed, Comminuted, Healing
Registration Number
NCT02188836
Lead Sponsor
Fundacion Clinica Valle del Lili
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
64
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Fracture healingup 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
NameTimeMethod
Infection6 months

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

Trial Locations

Locations (1)

Fundacion Valle del Lili

🇨🇴

Cali, Valle, Colombia

Fundacion Valle del Lili
🇨🇴Cali, Valle, Colombia

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