Physicians’ Guide: Improve Fusion Outcomes in At-risk Patients
PEMF Bone Growth Stimulation: Non-invasive, adjunct to post-operative care

More than 20 Years of Clinical Data

Validates BGS effectiveness & efficacy

Bone growth stimulation is a FDA-approved adjunctive therapy for bone fusion since the late 1980’s in long bones, early 1990’s in the lumbar spine, and mid-2000’s in cervical fusion cases. The table below summarizes compelling highlights from studies of lumbar and cervical spine fusion stimulation.

Spine Fusion Stimulation: Lead Author/Highlights

Lead Author Highlights
Lumbar

Mooney18,2
(Lumbar Adjunct Use IDE Study)

Lumbar fusion success rate in the PEMF group was 92% vs. 67.9% in the placebo group (p=0.005)

Simmons19
(Lumbar Failed Fusion IDE Study)

Lumbar fusion success rate for patients with pseudarthrosis at 9+ months was 67% (p=0.001); comparable to results from revision surgery

Bose20

Lumbar fusion success rate for PEMF treated patients was 97.9%, with 89% reporting excellent or good clinical outcomes

Silver21

Lumbar fusion success rate for PEMF treated patients was 97.9% (78% of patients were high risk)

Marks22

Lumbar fusion success rate for PEMF treated patients was 97.6% vs. 52.6% in untreated group
Cervical

Foley5
(Cervical IDE Study)

Cervical fusion success rate in the PEMF group was 84% vs. 69% in the placebo group (p=0.0065)

Obtain Clinical and Scientific Information
Spine Fusion Stimulation: Evidence by Category
Click to view summaries of important clinical and science papers, including sample sizes, results, devices and those with FDA-approval.  Categories include lumbar, cervical and scientific.

Dr. McCall's Clinical Perspectives

  • Practice overview
  • Convinced by the literature
  • Patient selection protocol
  • Risk factors and benefits
  • BMP and BGS
  • Personal clinical results
  • Cost effectiveness
Spine Fusion Stimulation: Evidence by Category

 

 

LUMBAR
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.
Sample: 85 patients
PEMF Device: Spinal-Stim® (Orthofix, Inc.)
Results: 97.7% of the patients attained solid fusion
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.
Garnered FDA Approval
Sample: 100 patients
PEMF Device: Spinal-Stim® (Orthofix, Inc.)
Results: 67% of patients with a previous failed fusion attained solid fusion without surgical intervention
Linovitz RJ, Pathria M, Bernhardt M, et al. Combined Magnetic Fields Accelerate and Increase Spine Fusion. A double-blind, randomized, placebo-controlled study. Spine. 2002 Jul 1;27(13):1383-9.
Garnered FDA Approval
Sample: 201 patients
Combined Magnetic Fields Device: DJO SpinaLogic®
Results: 64% healed at 9 months compared with 43% of patients with placebo devices.
Bose B. Outcomes after posterolateral lumbar fusion with instrumentation in patients treated with adjunctive pulsed electromagnetic field stimulation.  Advances in Therapy. 2001 Jan-Feb;(18)1:12-20.
Sample: 48 high-risk patients
PEMF Device: Spinal-Stim® (Orthofix, Inc.)
Results: 97.9% success rate demonstrated by independent radiographic assessment
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.
Sample: 61 patients
PEMF Device: Spinal-Stim® (Orthofix, Inc.)
Results: Fusion succeeded in 97.6% of the PEMF group and 52.6% of the unstimulated group (P < .001)
Goodwin CB, Brighton CT, Guyer RD, et al.  A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions.  Spine. 1999;Jul 1;24(13):1349-57.
Garnered FDA Approval
Sample: 179 patients
Capacitively Coupled Electrical Stimulation Device: Biomet SpinalPak®
Results: Overall success rate was 84.7% (dropped to 79% in completed study) for active patients and 64.9% for placebo patients
Mooney, V. Pulsed Electromagnetic Fields: An Adjunct to Interbody Spinal Fusion Surgery in the High Risk Patient. Surgical Technology International II. 1993;405-10.
Sample: 195 patients
PEMF Device: Spinal-Stim® (Orthofix, Inc.)
Results: Spinal fusion success rate was 92% in the PEMF and in the 68% in the placebo group (P< 0.001)
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.
Garnered FDA Approval
Sample: 195 patients
PEMF Device: Spinal-Stim® (Orthofix, Inc.)
Results: Spinal fusion success rate was 92% in the PEMF and in the 68% in the placebo group (P< 0.001)
Kane WJ. Direct current electrical bone growth stimulation for spinal fusion.  Spine. 1988;13(3):363-5.
Garnered FDA Approval
Samples:
Group 1: 82 patients
Group 2: 159 patients
Group 3: 116 patients
Direct Current Device: Biomet SpF®
Results: Success defined as radiographic fusion was achieved in 81% of treated patients and 54% of control patients. Success of a continued non-randomized study is 90.5% in an additional 116 patients.
CERVICAL
Foley KT, Mroz TE, Arnold PM, 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.
Garnered FDA Approval
Sample: 240 patients
PEMF Device: Cervical-Stim® (Orthofix, Inc.)
Results: At 6 months post-op, the PEMF group had a significantly higher fusion rate than the control group (83.6% vs. 68.6%, p=.0065)
SCIENCE
Selvamurugan N, Kwok S, Vasilov A, et al. Effects of BMP-2 and pulsed electromagnetic field (PEMF) on rat primary osteoblastic cell proliferation and gene expression. Journal of Orthopaedic Research. 2007 Sep;25(9):1213-20.
Summary: Osteoblast in vitro study comparing control, BMP, PEMF and BMP & PEMF together. BMP and PEMF alone were statistically significantly (SS) greater than control. BMP & PEMF together were SS greater than either alone (they were additive).
Schnoke M, Midura RJ. Pulsed electromagnetic fields rapidly modulate intracellular signaling events in osteoblastic cells: comparison to parathyroid hormone and insulin. Journal of Orthopaedic Research. 2007 Jul;25(7):933-40.
Summary: In vitro study of three signaling molecules suggesting that, within 10 minutes, PEMF activates a response in cell molecules/pathways known to be functionally associated with bone formation.
Patterson TE, Sakai Y, Grabiner MD, et al. Exposure of murine cells to pulsed electromagnetic fields rapidly activates the mTOR signaling pathway.  Bioelectromagnetics. 2006 Oct;27(7):535-44.
Summary: In vitro study suggesting that mTOR, a critical mediator protein controlling cell growth and proliferation, increases markedly in pre-osteoblasts as a result of PEMF exposure.
Midura RJ, Ibiwoye MO, Powell KA, et al. Pulsed electromagnetic field treatments enhance the healing of fibular osteotomies. Journal of Orthopaedic Research. 2005;23(5); 1035-46.
PEMF Device: Physio-Stim® (Orthofix, Inc.)
Summary: Within animal control study of PEMF effects on healing of fresh bone injury. Physio-Stim PEMF treatment resulted in statistically significant increase in rate of callus formation and osteotomy repair. These beneficial effects on bone healing were not observed with a different PEMF waveform.
Ibiwoye MO, Powell KA, Grabiner MD, et al. Bone mass is preserved in a critical-sized osteotomy by low energy pulsed electromagnetic fields as quantitated by in vivo micro-computed tomography. Journal of Orthopaedic Research. 2004 Sep;22(5):86-93.
PEMF Device: Physio-Stim® (Orthofix, Inc.)
Summary: Within animal control study of PEMF effects on bone growth in a critical-sized osteotomy (one that is not expected to heal at all); PEMF vs. control resulted in four-fold reduction in bone volume loss.
Zborowski M, Midura RJ, Wolfman A, et al. Magnetic field visualization in applications to pulsed electromagnetic field stimulation of tissues. Annals of Biomedical Engineering. 2003 Feb;31(2):195-206.
PEMF Device: Spinal-Stim Lite® (Orthofix, Inc.)
Summary: Studied electromagnetic field visualization as important to the molecular basis of the therapeutic effects of PEMF

Physician's Disclosure
Todd McCall, MD received no remuneration for his testimonial video commentaries.

Updated on: 02/21/12

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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