Pulsed Electromagnetic Field Therapy Improves Osseous Consolidation after High Tibial Osteotomy in Elderly Patients—A Randomized, Placebo-Controlled, Double-Blind Trial

Abstract

Extremely low-frequency pulsed electromagnetic field (ELF-PEMF) therapy is proposed to support bone healing after injuries and surgical procedures, being of special interest for elderly patients. This study aimed at investigating the effect of a specific ELF-PEMF, recently identified to support osteoblast function in vitro, on bone healing after high tibial osteotomy (HTO). Patients who underwent HTO were randomized to ELF-PEMF or placebo treatment, both applied by optically identical external devices 7 min per day for 30 days following surgery. Osseous consolidation was evaluated by post-surgical X-rays (7 and 14 weeks). Serum markers were quantified by ELISA. Data were compared by a two-sided t-test (α = 0.05). Device readouts showed excellent therapy compliance. Baseline parameters, including age, sex, body mass index, wedge height and blood cell count, were comparable between both groups. X-rays revealed faster osseous consolidation for ELF-PEMF compared to placebo treatment, which was significant in patients ≥50 years (∆mean = 0.68%/week; p = 0.003). Findings are supported by post-surgically increased bone-specific alkaline phosphatase serum levels following ELF-PEMF, compared to placebo (∆mean = 2.2 µg/L; p = 0.029) treatment. Adverse device effects were not reported. ELF-PEMF treatment showed a tendency to accelerate osseous consolidation after HTO. This effect was stronger and more significant for patients ≥50 years. This ELF-PEMF treatment might represent a promising adjunct to conventional therapy supporting osseous consolidation in elderly patients. Level of Evidence: I.

Postoperative management following osteotomies around the knee: a narrative review

“…It was shown that bone consolidation was significantly accelerated in a subcohort of patients over 50 years of age compared to the placebo group. In line with this, earlier increases in BAP (bone-specific alkaline phosphatase) serum levels, a marker of osteoblast activity, were detected in the intervention group ( 51 ). In contrast, Goshima et al showed in a recently published study on 136 knees that low-intensity pulsed ultrasound (LIPUS) does not promote bone healing after opening HTO ( 52 ).…”

“…In a randomized, placebo-controlled, double-blind study, Ziegler et al investigated the influence of ultra-low-frequency pulsed electromagnetic fields (16 Hz, 6-282 μT) on bone consolidation after HTO in patients over 40 years of age ( 51 ). Seventy-four patients were evaluated with regard to bone consolidation and blood serum markers.…”

Postoperative management following osteotomies around the knee: a narrative review

“…It was shown that bone consolidation was significantly accelerated in a subcohort of patients over 50 years of age compared to the placebo group. In line with this, earlier increases in BAP (bone-specific alkaline phosphatase) serum levels, a marker of osteoblast activity, were detected in the intervention group ( 51 ). In contrast, Goshima et al showed in a recently published study on 136 knees that low-intensity pulsed ultrasound (LIPUS) does not promote bone healing after opening HTO ( 52 ).…”

“…In a randomized, placebo-controlled, double-blind study, Ziegler et al investigated the influence of ultra-low-frequency pulsed electromagnetic fields (16 Hz, 6-282 μT) on bone consolidation after HTO in patients over 40 years of age ( 51 ). Seventy-four patients were evaluated with regard to bone consolidation and blood serum markers.…”

Exposure to 16 Hz Pulsed Electromagnetic Fields Protect the Structural Integrity of Primary Cilia and Associated TGF-β Signaling in Osteoprogenitor Cells Harmed by Cigarette Smoke

“…The effectiveness of the ELF-PEMF was confirmed in further studies, both in vitro and in vivo [25,29]. Comparing the effect on bone formation in this in vivo study [29] with other studies that used 4-to 200-times longer daily exposures revealed that increasing the exposure duration may enhance the observed effects [9]. Thus, in the present study, exposure duration was varied at first.…”

“…A screening approach identified ELF-PEMFs in this frequency range to best support the viability and differentiation of osteoprogenitor cells [12]. The effectiveness of the ELF-PEMF was confirmed in further studies, both in vitro and in vivo [25,29]. Comparing the effect on bone formation in this in vivo study [29] with other studies that used 4-to 200-times longer daily exposures revealed that increasing the exposure duration may enhance the observed effects [9].…”

Intermittent Exposure to a 16 Hz Extremely Low Frequency Pulsed Electromagnetic Field Promotes Osteogenesis In Vitro through Activating Piezo 1-Induced Ca2+ Influx in Osteoprogenitor Cells

“…In this study, daily exposure to the ELF-PEMF with a fundamental frequency of 16 Hz most effectively induced osteoblast function [5]. The clinical use of this specific 16 Hz ELF-PEMF confirmed this finding by accelerating osseous consolidation of high tibia osteotomies [6]. Although the non-invasive treatment and therapeutic effects of the 16 Hz ELF-PEMF were proven, the challenge of optimizing the ELF-PEMF treatment setting for therapeutic use remained.…”

Postoperative management following osteotomies around the knee: a narrative review

“…It was shown that bone consolidation was significantly accelerated in a subcohort of patients over 50 years of age compared to the placebo group. In line with this, earlier increases in BAP (bone-specific alkaline phosphatase) serum levels, a marker of osteoblast activity, were detected in the intervention group ( 51 ). In contrast, Goshima et al showed in a recently published study on 136 knees that low-intensity pulsed ultrasound (LIPUS) does not promote bone healing after opening HTO ( 52 ).…”

“…In a randomized, placebo-controlled, double-blind study, Ziegler et al investigated the influence of ultra-low-frequency pulsed electromagnetic fields (16 Hz, 6-282 μT) on bone consolidation after HTO in patients over 40 years of age ( 51 ). Seventy-four patients were evaluated with regard to bone consolidation and blood serum markers.…”

Exposure to 16 Hz Pulsed Electromagnetic Fields Protect the Structural Integrity of Primary Cilia and Associated TGF-β Signaling in Osteoprogenitor Cells Harmed by Cigarette Smoke

“…The effectiveness of the ELF-PEMF was confirmed in further studies, both in vitro and in vivo [25,29]. Comparing the effect on bone formation in this in vivo study [29] with other studies that used 4-to 200-times longer daily exposures revealed that increasing the exposure duration may enhance the observed effects [9]. Thus, in the present study, exposure duration was varied at first.…”

“…A screening approach identified ELF-PEMFs in this frequency range to best support the viability and differentiation of osteoprogenitor cells [12]. The effectiveness of the ELF-PEMF was confirmed in further studies, both in vitro and in vivo [25,29]. Comparing the effect on bone formation in this in vivo study [29] with other studies that used 4-to 200-times longer daily exposures revealed that increasing the exposure duration may enhance the observed effects [9].…”

Intermittent Exposure to a 16 Hz Extremely Low Frequency Pulsed Electromagnetic Field Promotes Osteogenesis In Vitro through Activating Piezo 1-Induced Ca2+ Influx in Osteoprogenitor Cells

“…In this study, daily exposure to the ELF-PEMF with a fundamental frequency of 16 Hz most effectively induced osteoblast function [5]. The clinical use of this specific 16 Hz ELF-PEMF confirmed this finding by accelerating osseous consolidation of high tibia osteotomies [6]. Although the non-invasive treatment and therapeutic effects of the 16 Hz ELF-PEMF were proven, the challenge of optimizing the ELF-PEMF treatment setting for therapeutic use remained.…”

Postoperative management following osteotomies around the knee: a narrative review

“…It was shown that bone consolidation was significantly accelerated in a subcohort of patients over 50 years of age compared to the placebo group. In line with this, earlier increases in BAP (bone-specific alkaline phosphatase) serum levels, a marker of osteoblast activity, were detected in the intervention group ( 51 ). In contrast, Goshima et al showed in a recently published study on 136 knees that low-intensity pulsed ultrasound (LIPUS) does not promote bone healing after opening HTO ( 52 ).…”

“…In a randomized, placebo-controlled, double-blind study, Ziegler et al investigated the influence of ultra-low-frequency pulsed electromagnetic fields (16 Hz, 6-282 μT) on bone consolidation after HTO in patients over 40 years of age ( 51 ). Seventy-four patients were evaluated with regard to bone consolidation and blood serum markers.…”

Exposure to 16 Hz Pulsed Electromagnetic Fields Protect the Structural Integrity of Primary Cilia and Associated TGF-β Signaling in Osteoprogenitor Cells Harmed by Cigarette Smoke

“…The effectiveness of the ELF-PEMF was confirmed in further studies, both in vitro and in vivo [25,29]. Comparing the effect on bone formation in this in vivo study [29] with other studies that used 4-to 200-times longer daily exposures revealed that increasing the exposure duration may enhance the observed effects [9]. Thus, in the present study, exposure duration was varied at first.…”

“…A screening approach identified ELF-PEMFs in this frequency range to best support the viability and differentiation of osteoprogenitor cells [12]. The effectiveness of the ELF-PEMF was confirmed in further studies, both in vitro and in vivo [25,29]. Comparing the effect on bone formation in this in vivo study [29] with other studies that used 4-to 200-times longer daily exposures revealed that increasing the exposure duration may enhance the observed effects [9].…”

Intermittent Exposure to a 16 Hz Extremely Low Frequency Pulsed Electromagnetic Field Promotes Osteogenesis In Vitro through Activating Piezo 1-Induced Ca2+ Influx in Osteoprogenitor Cells

“…In this study, daily exposure to the ELF-PEMF with a fundamental frequency of 16 Hz most effectively induced osteoblast function [5]. The clinical use of this specific 16 Hz ELF-PEMF confirmed this finding by accelerating osseous consolidation of high tibia osteotomies [6]. Although the non-invasive treatment and therapeutic effects of the 16 Hz ELF-PEMF were proven, the challenge of optimizing the ELF-PEMF treatment setting for therapeutic use remained.…”