Bone Growth Stimulator Treatment & Information

Some patients have difficulty healing after bone injuries and spinal fusion surgery. Certain health factors may impair the natural healing process of the bones in many of these cases. If health complications or risks impede your ability for your bones to heal naturally, it may take lengthy procedures or painful surgery for your bone to heal.^1-4 Bone growth stimulation, also known as bone growth therapy, is often prescribed to help overcome healing challenges.

OVERVIEW

One in every 20 bone fractures fails to heal correctly. Some fractures can take longer to heal than expected. This condition is referred to medically as a nonunion – when the fracture site shows no visible signs of healing.

When you fracture a bone, your body produces electric fields surrounding and in the fractured bone segments to encourage repair. These internal electrical fields are a critical, biological signaling process that is needed for the bone to grow and heal normally. Your bones are capable of healing themselves when damaged in much the same way as your skin and other tissues do.

A bone growth stimulator mimics the body’s natural signaling processes by applying an external electric field.

HISTORY OF BONE GROWTH STIMULATION

Experiments to use electrical currents to heal bones started in the mid-1800s. But it wasn’t until the 1950s that scientists discovered that when a human bone is bent or broken, it generates an electrical field. This low-level electrical field triggers the body’s own repair mechanism, which, in turn, promotes bone healing.^5-7

Bone growth stimulation devices have been available for over 30 years. Florida Orthopaedic Institute currently uses three products prescribed by your physician to your specific needs:

• Biomet® EBI® Bone Healing System
• Exogen® Ultrasound Bone Healing System
• Orthofix® Bone Growth Therapy devices

BENEFITS OF BONE GROWTH STIMULATION DEVICES

Bone growth stimulation devices provide a safe, non-invasive treatment that helps promote healing. They are prescribed for fractured bones and spinal fusions that have not healed or have had difficulty healing. They stimulate the bone’s natural healing process by sending low-level pulses of electromagnetic energy to the injury or fusion site.

• Designed for patient ease of use.
• Overall clinical success rate of 92% for adjunct spinal fusions. ^8,9
• FDA-approved.
• Proven, safe, and effective.
• As little as 20 minutes a day of safe, painless treatment.
• Significantly accelerates your body’s natural bone healing process and helps repair fractures that have failed to heal and might otherwise require surgery. ^10-12 (Results vary due to health, weight, activity, and other variables.)

FREQUENTLY ASKED QUESTIONS

Will my insurance cover the cost?
Insurance coverage varies based on your insurance plan, but most major health insurers cover bone growth stimulation as an indicated therapy for repairing nonunion fractures. ^13-16. It is also generally accepted by Medicare, Medicaid, workers compensation, and many private and public health plans.

How does a bone healing system work?
Each system varies, but most devices have an anatomically configured treatment coil placed over a cast or directly onto the skin. The coil is lightweight and easy to apply. An electronic control unit sends a pulsating energy field to the fracture nonunion or failed fusion site. Systems are battery-operated, portable, and easy to operate. You can treat your fracture nonunion or failed fusion while going about your daily routine, relaxing, or sleeping.

What is the process for obtaining a bone healing system?
You can only get a bone healing system with a doctor’s prescription. Not all patients are candidates. Only your doctor can determine the treatment appropriate for your specific condition. Your insurance company may need certain backup information.

How long will I have to use the device?
Systems vary, but you can assume a recommended daily treatment time of 8-10 hours per day. Your doctor will closely check your healing to determine how long you should use the device. Risk factors such as smoking, diabetes, osteoporosis, steroids, and alcohol can factor into the length of your treatment.

How do I know if my system is working?
All systems prescribed by Florida Orthopaedic Institute are designed to be convenient to use, comfortable to wear, and safe to operate. You will not feel the bone healing therapy as it delivers the therapeutic treatment signal to the nonunion or failed fusion site. Most systems have indicator displays that show when the system is activated correctly.

Are the systems safe to use in an MRI?
MRI scans should not be performed until your bone healing system has been completely removed.

I have a pacemaker. Can I use a bone healing system?
Probably not. The use of a pacemaker or cardioverter with some bone healing systems is not recommended. Check with your physician.

Are the systems safe to use during pregnancy?
The use of a bone healing system during pregnancy has not been evaluated with all systems, so it is not recommended. Check with your physician.

^References

^{1. Lerner A, Stein H, Soudry M. Compound high-energy limb fractures with delayed union: our experience with adjuvant ultrasound stimulation (exogen). Ultrasonics. 2004;42(1-9):915-7.}

^{2. Hernandez RK, Do TP, Critchlow CW, Dent RE, Jick SS. Patient-related risk factors for fracture-healing complications in the United Kingdom General Practice Research Database. Acta Orthop. 2012;83(6):653-60.}

^{3. Cook SD, Ryaby JP, McCabe J, Frey JJ, Heckman JD, Kristiansen TK. Acceleration of tibia and distal radius fracture healing in patients who smoke. Clin Orthop Relat Res. 1997;(337):198-207.}

^{4. Scolaro JA, Schenker ML, Yannascoli S, Baldwin K, Mehta S, Ahn J. Cigarette smoking increases complications following fracture: a systematic review. J Bone Joint Surg Am. 2014;96(8):674-81.}

^{5. Bassett, CA. Fundamental and practical aspects of therapeutic uses of pulsed electromagnetic fields (PEMFs). Crit Rev Biomed Eng. 1989; 17(5):451-529}

^{6. Yen-Patton GP, et al. Endothelial cell response to pulsed electromagnetic fields: stimulation of growth rate and angiogenesis in vitro. J Cell Physiol. 1988 Jan; 134(1): 37-46}

^{7. Zoltan, JD. Electrical Stimulation of Bone: An Overview. Seminars in Orthopaedics, Vol 1, No 4 (December), 1986: 242-252}

^{8. PMA P850007/S6. February 1990.}

^{9. Mooney V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields of interbody lumbar fusions. Spine. 1990 July;15(7):708-12. PubMed Abstract}

^{10. Heckman JD, Ryaby JP, McCabe J, Frey J, Kilcoyne RF. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994;76(1):26-34.}

^{11. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997;79(7):961-73.}

^{12. Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH. Low-intensity pulsed ultrasound in the treatment of nonunions. J Trauma. 2001;51(4):693-703.}

^{13. Aetna. Bone growth stimulators– medical clinical policy bulletin. www.aetna.com/cpb/medical/data/300_399/0343.html. Last updated July 28, 2017.}

^{14. Cigna. Cigna medical coverage policy. Bone growth stimulators: electrical (invasive, non-invasive), ultrasound. https://cignaforhcp.cigna.com/public/content/pdf/coveragePolicies/medical/mm_0084_coveragepositioncriteria_bone_growth_stimulators.pdf. Last updated April 15, 2017.}

^{15. Humana. Bone growth stimulators. Medical coverage policy. http://apps.humana.com/tad/tad_new/Search.aspx?searchtype=beginswith&docbegin=B&policyType=medical. Last updated March 23, 2017.}

^{16. United Healthcare. Electrical and ultrasound bone growth stimulators. www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20and%20Protocols/Medical%20Policies/Medical%20Policies/Electrical_and_Ultrasound_Bone_Growth_Stimulators.pdf. Last updated April 1, 2017.}