More information on the study can be found here.
DJO Global, Inc. (“DJO Global” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, announces the onset of a clinical trial for a new indication of the CMF OL1000 Bone Growth Stimulator.
Combined Magnetic Field (CMF) devices have been on the market since the early 1990s, providing medical professionals with a tool for the noninvasive treatment of an established non-union fracture acquired secondary to trauma, excluding all vertebrae and flat bones. Due to the type of signal technology, CMF devices are prescribed for a treatment time of 30-minutes per day. These battery-powered, FDA-approved medical devices can be used in conjunction with non-magnetic internal or external fixation, over a cast or brace.
DJO Global, through its subsidiary, Encore Medical L.P., initiated the application for an Investigational Device Exemption (IDE) Study with the U.S. Food and Drug Administration (FDA) for a new indication of the CMF technology into the fresh fracture market. The prospective, randomized, double-blinded, controlled, multi-center clinical study will evaluate the use of the CMF OL1000 as a noninvasive adjunctive treatment for closed, unstable ankle fractures that require surgical treatment for stabilization. The FDA-approved study initiated enrollment in January of this year.