DJO Global launches study to support new CMF OL1000 indication

DJO Global has announced the launch of a new clinical trial that aims to support the use of its CMF OL1000 Bone Growth Stimulator in a wider range of applications.

The study will evaluate the use of CMF OL1000 as a noninvasive adjunctive treatment for closed, unstable ankle fractures that require surgical treatment for stabilisation, with enrolment for the trial having commenced in January.

DJO Global and its subsidiary Encore Medica have had the trial approved by the US Food and Drug Administration as an investigational device exemption study, which if successful would support future regulatory applications for the technology to be used in a new indication for the fresh fracture market.

Combined magnetic field (CMF) devices have been used for the noninvasive treatment of established non-union fractures acquired secondary to trauma since the early 1990s, and are generally prescribed for a treatment time of 30 minutes per day.

Currently, these devices are used in conjunction with non-magnetic internal or external fixations over a cast or brace. With this new trial, DJO Global is seeking to facilitate their use in a wider range of applications.

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