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 fusion success rate in the PEMF group was 92% vs. 67.9% in the placebo group (p=0.005) |
Simmons19 |
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 fusion success rate in the PEMF group was 84% vs. 69% in the placebo group (p=0.0065) |
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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
PEMF Device: Spinal-Stim® (Orthofix, Inc.)
Results: 97.7% of the patients attained solid fusion
Sample: 100 patients
PEMF Device: Spinal-Stim® (Orthofix, Inc.)
Results: 67% of patients with a previous failed fusion attained solid fusion without surgical intervention
Sample: 201 patients
Combined Magnetic Fields Device: DJO SpinaLogic®
Results: 64% healed at 9 months compared with 43% of patients with placebo devices.
PEMF Device: Spinal-Stim® (Orthofix, Inc.)
Results: 97.9% success rate demonstrated by independent radiographic assessment
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)
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
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)
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)
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.
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)
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.
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.
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.
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.