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Clinical Solutions in Practice

New Bone Growth Stimulator Offers Treatment For Nonunion Fractures

By Aaron Becker, Special Projects Editor
March 2007

      Facilitating the healing of nonunion fractures can be challenging. In order to address this challenge, a number of practitioners have been turning to the DonJoy OL1000 Bone Growth Stimulator as it reportedly provides an easy to use, noninvasive treatment option.       The bone growth stimulator is a lightweight, battery-powered device that can accommodate a large variety of fracture sites, according to DJO Inc., the manufacturer of the device. While the bone growth stimulator is specifically indicated for the treatment of established nonunion fractures secondary to trauma (excluding all vertebrae and flat bones), Thomas Zgonis, DPM, has had success utilizing the device for other applications as well.       “I have used it in numerous reconstructive and revisional foot and ankle surgeries,” notes Dr. Zgonis, a Fellow of the American College of Foot and Ankle Surgeons, and a Diplomate of the American Board of Podiatric Surgery.       In addition to utilizing the device for nonunions, Dr. Zgonis says he has used the bone growth stimulator to help foster healing of failed arthrodesis sites, mal-unions and adjunctively for patients undergoing major limb salvage procedures such as Charcot reconstruction.

What The Studies Reveal

      According to DJO, pre-clinical studies have shown the efficacy of the DonJoy OL1000 Bone Growth Stimulator in stimulating healing of nonunion fractures.       In patients with nonunions that averaged 29.3 months from the time of injury, all with a mean of 2.5 prior surgeries, these studies show a 60.7 percent increased chance of healing. Registry data on over 2,300 patients reports a heal rate of 75.1 percent, according to the company.

Emphasizing Favorable Patient Compliance

      According to Dr. Zgonis, an Assistant Professor within the Department of Orthopaedics/Podiatry Division at the University of Texas Health Science Center in San Antonio, patients have responded very well to the OL1000.       “Patients are usually very compliant with the device since it is applied for 30 minutes a day and it can be used on top of an external fixation device, cast or any walking devices,” says Dr. Zgonis. “Also, direct skin contact is not necessary.”       Dr. Zgonis concedes there are always issues of patient noncompliance. However, the OL1000 device addresses this as well. “Close monitoring and time usage are available and recorded within the device,” points out Dr. Zgonis.

Keys To Proper Patient Selection

      According to DJO, use of the device is contraindicated in individuals having a synovial pseudarthrosis. The manufacturer also warns that demand-type pacemaker operations may be adversely affected by exposure to the magnetic fields utilized by the bone growth stimulator. The company says physicians should not prescribe the DonJoy OL1000 for applications that may place the treatment transducers in close proximity to the pacemaker. In these cases, further screening by a cardiologist is recommended, according to the company.       When considering possible use of the OL1000 device, Dr. Zgonis advises podiatrists to carefully consider the initial injury and its location, fracture gap size, serial radiographs and skeletal maturity. He says these considerations are vital to the decision of whether to use a bone growth stimulator or not.       DJO notes that no significant or serious adverse effects have resulted from the use of the OL1000. However, the company emphasizes caution when considering the device in cases of a misaligned nonunion. Treatment with the use of the OL1000 is not intended to alter or affect the degree of misalignment, according to DJO.

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