Physicians’ Guide: Improve Fusion Outcomes in At-risk Patients

PEMF Bone Growth Stimulation: Non-invasive, adjunct to post-operative care

PEMF Impacts Bone Healing at a Molecular, Cellular and Tissue Level

Spinal fusion is a standard of surgical care for many patients with lumbar or cervical disorders. While surgeons agree that the goal of spinal fusion is solid arthrodesis, this is difficult to achieve in patients at risk for non-union. Orthofix Spinal Fusion Stimulators generate a Pulsed Electromagnetic Field (PEMF) signal that stimulates bone cell growth at the molecular, cellular and tissue levels creating an environment more conducive to bone healing in patients at risk for a failed spinal fusion.

MOLECULAR

Within 10 minutes of PEMF exposure, signaling pathways are activated.*

Research on the molecular impact of PEMF demonstrates^7-13:

Exposure of a bone-forming cell (osteoblast) to PEMF generates an electric field gradient across the cell membrane.

Following this activation, bone cells recognize PEMF with an immediate intracellular response.

Similar to growth factors (PTH and Insulin); PEMF activates signaling pathways within minutes.

These different signaling pathways have been shown to cause cell growth, proliferation, and differentiation (PI3-mTOR-p70-s6).

CELLULAR

PEMF stimulates bone cells to proliferate, differentiate, and mineralize.*

Research advances understanding of how PEMF facilitates bone growth at the cellular level^9-13:

PEMF treatment causes a significant increase in expression for genes involved in proliferation, differentiation, and mineralization.

The use of PEMF and BMP-2 together has been documented to have an additive effect on cell growth and proliferation, which suggests each intervention utilizes a separate intracellular signaling pathway.

TISSUE

PEMF has been shown to improve the quality of bone tissue and enhance bone preservation.*

Research documents PEMF’s significant effect on bone tissue.^14-15:

PEMF increases bone volume and quality.
PEMF slows bone resorption in a pre-clinical disuse model.

*PEMF has also been clinically proven to be a safe and effective noninvasive treatment to improve healing rates.^16-17

Disclaimer: The results of pre-clinical studies may not be indicative of human clinical trials.

View Sources

1 iData Research, U.S. Market for Spinal Implants and VCF, 2010.

2 Mooney V. Pulsed Electromagnetic Fields: An Adjunct to Interbody Spinal Fusion Surgery in the High Risk Patient. Surgical Technology International II. 1993;405-10.

3 Bernard T. Repeat Lumbar Spine Surgery: Factors Influencing Outcome. Spine. 1993;18:2196-2200.

4 Martin B, et al. Reoperation Rates Following Lumbar Spine Surgery and the Influence of Spinal Fusion Procedures. Spine. 2007;32(3):382

5 Foley K., et al. Randomized, Prospective, and Controlled Clinical Trial of Pulsed Electromagnetic Field Stimulation for Cervical Fusion. The Spine Journal. 2008 May-Jun;8(3):436-42.

6 Bassett, CAL. Fundamental and Practical Aspects of Therapeutic Uses of Pulsed Electromagnetic Fields (PEMFs). Critical Reviews in Biomedical Engineering. 1989;17(5):451.

7 Barnes F, Greenebaum B. Biological and Medical Aspects of Electromagnetic Fields. CRC Press. 2007.

8 Panagolous DJ, Karabarbounis AK, Margaritis LH. Mechanism for action of electromagnetic fields on cells. Biochem Biophys Res Commun. 2002;298:95-102.

9 Patterson TE, Sakai Y, Grabiner MD, et al. Exposure of murine cells to pulsed electromagnetic fields rapidly activates the mTOR-signaling pathway. Bioelectromagnetics. 2006;27(7):535-44.

10 Zborowski M, Kligman B, Midura RJ, et al. Decibel attenuation of pulsed electromagnetic field (PEMF) in blood and cortical bone determined experimentally and from the theory of ohmic losses. Ann Biomed Eng. 2006;34(6):1030-41.

11 Zborowski M, Midura RJ, Wolfman A, et al. Magnetic field visualization in applications to pulsed electromagnetic field stimulation of tissues. Ann Biomed Eng. 2003;31(2):195-206.

12 Schnoke M, Midura RJ. Pulsed electromagnetic fields rapidly modulate intracellular signaling events in osteoblastic cells: comparison to parathyroid hormone and insulin. J Orthop Res. 2007;25(7):933-40.

13 Selvamurugan N, Kwok S, Vasilov A, Jefcoat SC, Partridge NC. Effects of BMP-2 and pulsed electromagnetic field (PEMF) on rat primary osteoblastic cell proliferation and gene expression. J Orthop Res. 2007;25(9):1213-20.

14 Midura RJ, Ibiwoye MO, Powell, KA, et al. Pulsed electromagnetic field treatments enhance the healing of fibular osteotomies. J Orthop Res. 2005;23:1035-46.

15 Ibiwoye MO, Powell KA, Grabiner MD. Bone mass is preserved in a critical-sized osteotomy by low energy pulsed electromagnetic fields as quantitated by in vivo micro-computed tomography. J Orthop Res. 2004;22(5):1086-93

16 PMA P850007. February 1990.

17 PMA P030034. December 2004.

18 Mooney V. A Randomized Double-blind Prospective Study of the Efficacy of Pulsed Electromagnetic Fields of Interbody Lumbar Fusions. Spine. 1990;15(7):708-12.

19 Simmons JW Jr., Mooney V., Thacker I. Pseudarthrosis after lumbar spine fusion: non-operative salvage with pulsed electromagnetic fields. American Journal of Orthopedics. 2004;33(1):27-30.

20 Bose B. Outcomes after posterolateral lumbar fusion with instrumentation in patients treated with adjunctive pulsed electromagnetic field stimulation. Advances in Therapy. 2001;18(1):12-20, DOI: 10.1007/BF02850247.

21 Silver RA. Application of Pulsed Electromagnetic Fields (PEMF) After Lumbar Interbody or Posterolateral Spinal Fusion Surgery in a Heterogenous Patient Population. The Journal of Neurological and Orthopaedic Medicine and Surgery. 2001;21(2):51-62.

22 Marks RA. Spine fusion for discogenic low back pain: outcomes in patients treated with or without pulsed electromagnetic field stimulation. Advances in Therapy. 2000 Mar-Apr;17(2):57-67.

Updated on: 12/10/18

Statement of Indications
Spinal-Stim is a non-invasive electromagnetic bone growth stimulator indicated as an adjunct therapy to increase the probability of fusion success and as a non-operative treatment of salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.

Cervical-Stim is a non-invasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct therapy to cervical fusion surgery in patients at high-risk for non-union.

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PEMF Impacts Bone Healing at a Molecular, Cellular and Tissue Level

Within 10 minutes of PEMF exposure, signaling pathways are activated.*

PEMF stimulates bone cells to proliferate, differentiate, and mineralize.*

PEMF has been shown to improve the quality of bone tissue and enhance bone preservation.*

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