Why Consider Spine Fusion Stimulation?

Surgeon's choice for patients at-risk of pseudarthrosis

Spinal fusion is a standard of surgical care for many patients with lumbar or cervical disorders. Degenerative disc disease, spinal stenosis, spondylolisthesis, and trauma typify causes of lumbar and cervical problems. Indications for fusion include spinal instability, intractable pain, and neurological dysfunction.

While surgeons agree that the goal of spinal fusion is solid arthrodesis, this is difficult to achieve in patients at risk for non-union. In fact, of the approximately 661,000¹ spinal fusions performed in 2009, the incidence of pseudarthrosis reported in the literature varied widely, ranging from 66%² to 95%.³ In addition, revision procedures are costly, difficult surgeries with lower success rates compared to primary fusion surgeries.^4-5

Improve Spinal Fusion Outcomes

This Physicians’ Guide provides important information to improve fusion outcomes in high-risk patients. Identifying patients at-risk for pseudarthrosis is the first step followed by applying Orthofix^® bone growth stimulation (BGS) as adjunctive therapy for lumbar or cervical fusion, or as a non-surgical alternative for failed lumbar fusion.

“There is a substantial amount of literature to show the efficacy of PEMF bone growth stimulation. The studies show that patients, in particular those with high risk factors….are key candidates.”

Todd McCall, MD

Assistant Professor of Neurosurgery

University of Illinois, College of Medicine

“I’ve seen a significant drop in my pseudarthrosis rates — it is probably under 5%…this is despite the facts that the patients in many cases fall into these high risk categories.”

Jonathan P. Partington, MD

Neurosurgeon

Neurosurgical Specialists, Inc.

Orthofix Spinal-Stim^® and Cervical-Stim^® BGS facilitates vascularization, mineralization of osteoid material, and promotes osteoblastic migration essential in bone healing.⁶ These FDA-approved devices utilize pulsed electromagnetic field (PEMF) technology. The efficacy of PEMF technology is well-supported in lumbar and cervical studies.

Physicians' Disclosures
Todd McCall, MD received no remuneration for his testimonial video commentaries.

Jonathan P. Partington, MD received no remuneration for his testimonial video commentaries.

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: 12/31/14

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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Why Consider Spine Fusion Stimulation?

Surgeon's choice for patients at-risk of pseudarthrosis

Improve Spinal Fusion Outcomes

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