Fracture, Closed, Comminuted, Healing
Conditions
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.
Interventions
Electromagnetic stimulation with a new device produced by the investigators for this study.
DEVICESham 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.
Sponsors
Fundacion Clinica Valle del Lili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sham electromagnetic device
Intervention model description
Electromagnetic device
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Infection | 6 months | Percentage (%) in each arm which may present an infection. |
Countries
Colombia
Outcome results
None listed