Electromagnetic stimulation as coadjuvant in the healing of diaphyseal femoral fractures: a randomized controlled trial

Abstract

Introduction: There is controversy in medical literature regarding the use of electromagnetic fields to promote bone healing. Methods: After designing and building devices capable of generating an electromagnetic field for this study, their safety was confirmed and the electromagnetic therapy was randomly allocated and compared to placebo in patients with fracture of the femoral diaphysis. Treatment began six weeks after the fracture and it was administered once a day, during 1 h, for eight consecutive weeks. Twenty devices were built, 10 of which were placebo-devices. Between June 2008 and October 2009, 64 patients were randomized in two different hospitals and were followed for 24 weeks. The mean age was 30 years (18-59) and 81% were males. Results: Healing observed at week 12 was 75% vs. 58% (p= 0.1); at week 18, it was 94% vs. 80% (p= 0.15); and at week 24, it was 94% vs. 87% (p= 0.43) for the device group and the placebo group, respectively. Discussion: This study suggests that an electromagnetic field stimulus can promote earlier bone healing compared to placebo in femoral diaphyseal fractures. Faster bone healing translates into sooner weight bearing, which – in turn – permits quicker return to normal daily activities.

Translational Insights into Extremely Low Frequency Pulsed Electromagnetic Fields (ELF-PEMFs) for Bone Regeneration after Trauma and Orthopedic Surgery

“…hour was sufficient to induce fracture healing [109]. In line with this, the study of Cheing et al showed that 30 minutes ELF-PEMF (∆tb = n.s.…”

“…Strongest effects were observed with an ELF-PEMF treatment of 75 Hz applied for ≥8 h per day for 90 days [108], however, it is not clear whether this effect is attributed to the higher frequency, other specific ELF-PEMF characteristics, and/or the higher age. Interestingly, solid results were observed when applying the ELF-PEMF with a range of frequencies-with this ELF-PEMF, a daily exposure of 1 h was sufficient to induce fracture healing [109]. In line with this, the study of Cheing et al showed that 30 min ELF-PEMF (∆t b = n.s.…”

“…Similarly, there are five prospective and blinded studies investigating the effect of ELF-PEMF treatment on acute fracture healing for the femur [108,109], tibia [110], or scaphoid [111,112] ( Figure 4). These studies use ELF-PEMFs with fixed frequencies [108,[110][111][112] or a frequency range (5-105 Hz [109]).…”

“…Similarly, there are five prospective and blinded studies investigating the effect of ELF-PEMF treatment on acute fracture healing for the femur [108,109], tibia [110], or scaphoid [111,112] ( Figure 4). These studies use ELF-PEMFs with fixed frequencies [108,[110][111][112] or a frequency range (5-105 Hz [109]). Three studies used ELF-PEMF generators approved for medical use-EBI Bone Healing System (Zimmer Biomet, Warsaw, IN, USA) [110] and Bone Growth Stimulator (OSSATEC, Uden, The Netherlands) [111,112].…”

“…or a frequency range Hz[109]). Three studies used ELF-PEMF generators approved for medical use-EBI Bone Healing System (Zimmer Biomet, Warsaw, IN, USA)[110] and Bone Growth Stimulator (OSSATEC, Uden,…”