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 . 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.
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 .
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.
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.
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 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 . 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 . In another study of over 2300 patients, healing rates ranged from 64.0% to 89.7% depending on fracture location .
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 . 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 .
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. . A clinical study of this device demonstrated success rates of 80% when used for more than 3 hours per day . 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 . 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 .
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 . Another study showed a success rate (at a 6-month follow up) of 88% in tibia and femoral bone nonunion fractures . Exogen’s LIPUS device provides these results in just 20 minutes per day . Exogen reports that their system has over double the number of clinical studies than all of their competitors combined .
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 . 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.