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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-21

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

Name	Time	Method
Fracture healing	up 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

Name	Time	Method
Infection	6 months	Percentage (%) in each arm which may present an infection.

Trial Locations

Locations (1)

Fundacion Valle del Lili; 🇨🇴 Cali, Valle, Colombia