Bone stimulators mimic the energy a broken bone generates

Human bone is living tissue, and thus has the ability to heal itself when it is injured or broken. There are a number of complex molecular reactions that occur during the bone healing process. These coordinated reactions are triggered by an electrical field that is internally generated when bone is broken or bent. This low-level electrical field is part of the body’s natural process that stimulates bone healing.2

Bone stimulators promote bone healing by applying an external energy field to a broken bone, mimicking this aspect of the body’s natural bone healing process.1 The energy from these devices enhance the bone healing process by triggering the cascade of complex molecular reactions that occur during the bone healing process.3  

There are several different types of technologies that are used by bone stimulators to generate the energy they apply to a broken bone. These different technologies include direct current, capacitive coupling, pulsed electromagnetic fields, and low-intensity pulsed ultrasound.1 The most commonly used bone stimulators are electrical stimulators and ultrasound stimulators.3

Bone stimulators come in different shapes and sizes. A small battery pack is the source of energy for most bone stimulators. Bone stimulators are usually attached at the site of the fracture and worn for a specific period of time each day, varying from minutes to hours.3

Nonunion fractures

Bone stimulators are used to facilitate healing of acute or fresh fractures, as well as nonunion fractures.1 These types of fractures may be the result of a complication, such as an infection at the site of the injury or impaired blood flow to the site of the bone tissue. People who have diabetes or smoke cigarettes may have impaired blood flow to the broken bone. Other causes of a nonunion fracture may be improper alignment of the broken ends of the bone or inadequate immobilization during the healing process.4,5

Efficacy of Ultrasound Bone Stimulation

Based on clinical evidence of efficacy, in 1994 the Food and Drug Administration (FDA) first approved the use of ultrasound bone stimulation for the treatment of certain fresh fractures.*2 Since then, ultrasound bone stimulation has also been approved for the treatment of established nonunion fractures.

Preclinical research in laboratory animals has found that the low-intensity pulsed ultrasound device enhances a number of molecular reactions involved in bone healing.6-12† Clinical research in patients with a bone fracture has provided further support for the efficacy of ultrasound bone stimulation; the time to heal fresh fractures was accelerated by 38%, and 86% of established nonunion fractures were healed with ultrasound bone stimulation.13-15

EXOGEN Ultrasound Bone Healing System

EXOGEN provides pulsed ultrasound bone stimulation. This device delivers safe, low-intensity ultrasound waves that trigger the natural bone healing process. Daily treatment with EXOGEN facilitates your natural bone healing by three actions:6-12

  • Stimulation: sends ultrasound waves through skin and soft tissue to the site of the fracture
  • Activation: ultrasound waves activate cell receptors critical for the cellular processes of bone repair16
  • Upregulation: ultrasound waves increase the expression of genes and proteins essential for bone repair17-22

The effects of EXOGEN on bone healing have been proven in more than twice the number of clinical trials of all other bone stimulation devices combined.23 Indicated for the treatment of certain fresh fractures* and nonunion fractures, EXOGEN is covered by most major health insurers.

With treatments taking just 20 minutes a day, EXOGEN provides safe treatment that facilitates faster healing of fresh fractures and restoration of nonunion fracture healing. Just use the small, lightweight and easy to use device on a daily basis. This is essential for EXOGEN to work properly. The device automatically records each treatment so you can track your daily progress.

Want to know more about this product? Please take a look at the most commonly asked questions about the EXOGEN device, and get the answers to your questions. Or read more about how EXOGEN´s bone stimulator works here, and find out if it’s right for you!

† The clinical significance of these findings is unknown.
‡ Safety and adverse events statement (RANDALL)
§ In vitro performance may not be indicative of performance in humans.

References

  1. Cook JJ, Summers NJ, Cook EA. Healing in the new millennium: bone stimulators: an overview of where we've been and where we may be heading. Clin Podiatr Med Surg. 2015;32(1)45-59. doi: 10.1016/j.cpm.2014.09.003.
  2. Victoria G, Petrisor B, Drew B, Dick D. Bone stimulation for fracture healing: What's all the fuss? Indian J Orthop. 2009[43(2):117-20. doi: 10.4103/0019-5413.50844.
  3. Cluett J. How bone growth stimulators work. Last updated September 13, 2019. www.verywellhealth.com/bone-growth-stimulator-4587797.
  4. Sousa CP, Dias IR, Lopez-Pena M, et al.  Bone turnover markers for early detection of fracture healing disturbances: A review of the scientific literature. An Acad Bras Cienc. 2015.87(2):1049-61. doi: 10.1590/0001-3765201520150008.
  5. NYU Langone Health. Diagnosing nonhealing fractures. Accessed October 7, 2019. https://nyulangone.org/conditions/nonhealing-fractures-in-adults/diagnosis.
  6. Tang CH, Yang RS, Huang TH, et al. Ultrasound stimulates cyclooxygenase-2 expression and increases bone formation through integrin, focal adhesion kinase, phosphatidylinositol 3-kinase, and Akt pathway in osteoblasts. Mol Pharmacol. 2006;69(6):2047-57. doi:  10.1124/mol.105.022160.
  7. Naruse K, Sekiya H, Harada Y, et al. Prolonged endochondral bone healing in senescence is shortened by low-intensity pulsed ultrasound in a manner dependent on COX-2.◦Ultrasound Med Biol. 2010;36(7):1098-108. doi: 10.1016/j.ultrasmedbio.2010.04.011.
  8. Lai CH, Chen SC, Chiu LH, et al. Effects of low-intensity pulsed ultrasound, dexamethasone/TGF-ß1 and/or BMP-2 on the transcriptional expression of genes in human mesenchymal stem cells: chondrogenic vs. osteogenic differentiation.◦Ultrasound Med Biol. 2010;36(6):1022-33. doi: 10.1016/j.ultrasmedbio.2010.03.014.
  9. Leung KS, Cheung WH, Zhang C, Lee KM, Lo HK. Low intensity pulsed ultrasound stimulates osteogenic activity of human periosteal cells.◦Clin Orthop Relat Res. 2004;(418):253-9. doi: 10.1097/00003086-200401000-00044.
  10. Leung KS, Cheung WH, Zhang C, Lee KM, Lo HK. Low intensity pulsed ultrasound stimulates osteogenic activity of human periosteal cells.◦Clin Orthop Relat Res. 2004;(418):253-9. doi: 10.1097/00003086-200401000-00044.
  11. Sant’Anna EF, Leven RM, Virdi AS, Sumner DR. Effect of low intensity pulsed ultrasound and BMP-2 on rat bone marrow stromal cell gene expression.◦J Orthop Res. 2005;23(3):646-52. doi: 10.1016/j.orthres.2004.09.007.
  12. Schofer MD, Block JE, Aigner J, Schmelz A. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010;11(1):229. doi: 10.1186/1471-2474-11-229.
  13. Heckman JD, Ryaby JP, McCabe J, et al. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound.◦J Bone Joint Surg Am. 1994;76(1):26-34. doi: 10.2106/00004623-199401000-00004.
  14. 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. doi: 10.2106/00004623-199707000-00002.
  15. 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. doi: 10.1097/00005373-200110000-00012.
  16. Tang CH, Yang RS, Huang TH, et al. Ultrasound stimulates cyclooxygenase-2 expression and increases bone formation through integrin, focal adhesion kinase, phosphatidylinositol 3-kinase, and Akt pathway in osteoblasts. Mol Pharmacol 2006;69(6):2047-57.
  17. Naruse K, Sekiya H, Harada Y, et al. Prolonged endochondral bone healing in senescence is shortened by low-intensity pulsed ultrasound in a
  18. Lai CH, Chen SC, Chiu LH, et al. Effects of low-intensity pulsed ultrasound, dexamethasone/TGF-ß1 and/or BMP-2 on the transcriptional expression of genes in human mesenchymal stem cells: chondrogenic vs. osteogenic differentiation. Ultrasound Med Biol. 2010;36(6):1022-33.
  19. Leung KS, Cheung WH, Zhang C, Lee KM, Lo HK. Low intensity pulsed ultrasound stimulates osteogenic activity of human periosteal cells. Clin Orthop Relat Res. 2004;(418):253-9.
  20. Coords M, Breitbart E, Paglia D, et al. The effects of low-intensity pulsed ultrasound upon diabetic fracture healing. J Orthop Res. 2011;29(2):181-8. Sant’Anna EF, Leven RM, Virdi AS, Sumner DR. Effect of low intensity pulsed ultrasound and BMP-2 on rat bone marrow stromal cell gene expression. J Orthop Res. 2005;23(3):646-52.
  21. Sant’Anna EF, Leven RM, Virdi AS, Sumner DR. Effect of low intensity pulsed ultrasound and BMP-2 on rat bone marrow stromal cell gene expression. J Orthop Res. 2005;23(3):646-52.
  22. Schofer MD, Block JE, Aigner J, Schmelz A. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010;11(1):229. doi: 10.1186/1471-2474-11-229.
  23. Bioventus LLC. EXOGEN studies and competitor studies analysis literature search, United States. Data on File, RPT-000557: 2016.