‪(724) 343-1850‬

Talk to us live

Order a Unit

Securely send us your info

Do Bone Growth Stimulators Work?

What is a nonunion fracture?

A nonunion fracture is a fracture (broken bone) that fails to heal. The United States Food and Drug Administration (FDA) currently defines a nonunion fracture as a bone that has not completely healed within 9 months of injury and that has not shown progression toward healing over 3 consecutive months on serial radiographs [1]. These types of fractures can occur in many different types of bones, including bones of the hands, arms, ankles, legs, and spine. Difficult as they may be to treat, there are indeed options available for individuals who are suffering from a nonunion fracture.

 

What are the treatment options?

If an individual has a nonunion fracture, there are steps the individual can take to facilitate the healing process. Some people undergo surgery first to try and repair the fracture. One example of a surgical procedure for nonunion fractures is a bone graft. Bone grafts provide fresh bone cells and other natural chemicals to the bone in order to aid growth and healing. Surgical stabilization using metal plates and/or screws is also an option. Other options that may be considered are external stabilization methods and casting [2]. 

 

After a particular surgical method is employed, it is usually necessary to wait a while to see if it worked, before other treatment can be sought. This wait usually needs to be about 3 months. In fact, most insurance companies won’t consider covering additional treatment of a nonunion fracture until a period of 3 months with no significant healing has passed. If additional treatment is warranted, it will often involve the use of a bone growth stimulation device. Bone growth stimulation is a treatment that promotes healing of nonunion fractures. Additionally, bone growth stimulators can be used as an alternative to surgery.

 

Bone growth stimulators

What are bone growth stimulators? A bone growth stimulator is a small device that administers either electrical, electromagnetic, or ultrasonic pulses (depending on the type or brand) to the fractured area in order to promote healing. The top three bone stimulator devices are Combined Magnetic Field (CMF),   Pulsed Electromagnetic Field (PEMF), or Low Intensity Pulsed Ultrasound (LIPUS) devices. Research, in fact, supports the use of these bone growth stimulators. Clinical studies demonstrate overall success rates that range from 61.9% (a CMF device used for 9-months) to 92.2% (a PEMF device used for a year) of nonunion fracture cases [3,4]. There are several companies that produce these devices, and each brand has its own advantages, as described here.

 

 

Do Bone Growth Stimulators Work?

 

If you are looking for a bone growth stimulation device, it is important to consider the healing rates of the currently available bone stimulators available on the market today. What is the best bone growth stimulator? In an attempt to answer this question, we will explore the clinical studies surrounding several bone growth stimulator companies.

 

DJO Global – Combined Magnetic Field (CMF) 

DJO Global offers two bone growth stimulator CMF products. The DJO CMF OL1000 Bone Growth Stimulator is a portable, battery-powered device that is used for noninvasive treatment of a nonunion fracture [6]. Research supports the use of these CMF bone stimulators. In fact, one clinical study demonstrates an overall success rate of 61.9% for nonunion fractures [7]. In another study of over 2300 patients, healing rates ranged from 64.0% to 89.7% depending on fracture location [8]. 

 

DJO Global also offers the CMF SpinaLogic. This is a portable, battery-powered, micro-controlled, noninvasive bone growth stimulator that is indicated as an additional treatment to primary lumbar spinal fusion surgery [9]. Studies show that this product works. In one study, patients receiving CMF stimulation with the CMF SpinaLogic device fused 75 days faster than patients receiving Pulsed Electromagnetic Field (PEMF) stimulation and 42 days faster than patients receiving Capacity Coupling (CC) stimulation [10].

 

Orthofix – Pulsed Electromagnetic Field (PEMF)

Orthofix currently has three PEMF bone stimulator devices available. The PhysioStim device from Orthofix is approved by the Federal Drug Administration (FDA) for the treatment of nonunion fractures of the arm/wrist/hand, shoulder, collar bone, hip, lower leg/ankle/foot, and thigh. [11]. A clinical study of this device demonstrated success rates of 80% when used for more than 3 hours per day [12]. SpinalStem is another of Orthofix’s products that is indicated for bone growth stimulation of the spinal cord. This product has also been supported in a clinical setting. In one study, surgical patients who used the device consistently for a year as after surgery developed solid fusion of the fracture in 92.2% of the cases [13]. Finally, a third product by Orthofix, the CervicalStim, meant to fuse fractures of the neck, has been shown to be 84% effective in the clinical setting [14].

 

Exogen – Low Intensity Pulsed Ultrasound (LIPUS) 

Exogen’s ultrasound bone healing stimulator is another option to assist with the healing of nonunion fractures. Exogen’s device uses LIPUS technology to stimulate the body’s natural bone healing process. Clinical evidence supports the use of Exogen’s bone healing system for nonunion long bone fractures [15]. Another study showed a success rate (at a 6-month follow up) of 88% in tibia and femoral bone nonunion fractures [16]. Exogen’s LIPUS device provides these results in just 20 minutes per day [17]. Exogen reports that their system has over double the number of clinical studies than all of their competitors combined [18].

 

Summary

Nonunion fractures are fractures that are resistant to healing. In order to heal these fractures, there are several options. The first option is usually surgery. Alternatively, or in addition to surgery, a bone growth stimulator device can be used. These devices are even supported by science as an effective way to accelerate the healing of nonunion fractures [16]. Which bone growth stimulator is best for you will depend on your own personal needs, such as the location of your nonunion fracture. Learn more about nonunion fractures here.

 

There are several manufacturers for cone growth stimulators (DJO Global, Orthofix, and Exogen). Which device is best for you will depend on your own personal circumstances and needs. All of these devices appear to be well supported by the clinical literature. Fracture location should be taken into account when comparing products. An additional consideration is the amount of time you are able to commit to wearing the product each day. Find out more about the differences between these three different companies’ products here. 

 

 

References

  1. Brinker MR: Skeletal Trauma: Basic Science, Management, and Reconstruction, ed 3. Philadelphia, PA: Saunders, 2003, pp 507-604.
  2. Lynch JR, Taitsman LA, Barei DP, Nork SE. Femoral nonunion: risk factors and treatment options. JAAOS-Journal of the American Academy of Orthopaedic Surgeons. 2008;16(2):88-97.
  3. Phillips M, Zoltan J, Petrisor BA, Sprague S, Baumhauer J. The Use of Combined Magnetic Field Treatment for Fracture Nonunions: A Prospective Observational Study. Journal of Long-Term Effects of Medical Implants. 2016;26(3).
  4. Mooney V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions. Spine. 1990;15(7):708-12.
  5. Heckman JD. Ryaby JPm McCabe J et al. Accelerative of tibial fracture-healing by non-invasive low-intensity pulsed ultrasound. J Bone Joint Surf Am. 1994;76(1):26-34.
  6. CMF OL1000™. 2020. Accessed 8/25/2020. https://www.djoglobal.com/products/cmf/cmf-ol1000
  7. Phillips M, Zoltan J, Petrisor BA, Sprague S, Baumhauer J. The Use of Combined Magnetic Field Treatment for Fracture Nonunions: A Prospective Observational Study. Journal of Long-Term Effects of Medical Implants. 2016;26(3).
  8. Phillips M, Baumhauer J, Sprague S, Zoltan J. Use of Combined Magnetic Field Treatment for Fracture Nonunion. Journal of Long-Term Effects of Medical Implants. 2016;26(3).
  9. CMF SPINALOGIC®. 2020. Accessed 8/25/2020. https://www.djoglobal.com/products/cmf/cmf-spinalogic
  10. Elsabeh R, Stegall R, Abrahams J. Increased Spinal Lumbar Fusion with Combined Magnetic Field (CMF) Bone Growth Stimulation. J Orthop Surg Tech. 2020;3(1):84-91.
  11. Product Features & Benefits. Accessed 8/25/2020. http://www.bonegrowththerapy.com/therapies/physiostim-arm-wrist-hand
  12. Garland DE, Moses B, Salyer W. Long-term follow-up of fracture nonunions treated with PEMFs. Contemporary orthopaedics. 1991;22(3):295-302.
  13. Mooney V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions. Spine. 1990;15(7):708-12.
  14. Foley KT, Mroz TE, Arnold PM, Chandler Jr HC, Dixon RA, Girasole GJ, Renkens Jr KL, Riew KD, Sasso RC, Smith RC, Tung H. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. The Spine Journal. 2008;8(3):436-42.
  15. Higgins A, Glover M, Yang Y, Bayliss S, Meads C, Lord J. EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing: a NICE medical technology guidance. Applied health economics and health policy. 2014;12(5):477-84.
  16. Roussignol X, Currey C, Duparc F, Dujardin F. Indications and results for the Exogen™ ultrasound system in the management of non-union: a 59-case pilot study. Orthopaedics & Traumatology: Surgery & Research. 2012;98(2):206-13.
  17. Heckman JD. Ryaby JPm McCabe J et al. Accelerative of tibial fracture-healing by non-invasive low-intensity pulsed ultrasound. J Bone Joint Surf Am. 1994;76(1):26-34.
  18. Bioventus LLC. EXOGEN studies and competitor studies analysis literature search, United States. Data on File, RPT-000557: 2016.