DJO Global said an independent study of its CMF SpinaLogic non-invasive electrical stimulation device showed a higher rate of healing following lumbar fusion surgery.
The prospective, randomized, double-blind trial by Oregon Health & Science University included 46 patients who had undergone lumbar fusion surgery. The trial showed a 49% increase in the overall healing rate in the 27 patients who received combined magnetic field (CMF) treatment with SpinaLogic over those treated with a placebo.
None of the patients treated with the CMF device required re-operation for pseudarthrosis, the study showed. The results were presented at Spine Summit 2019 in Miami, Fla.
“There are a number of factors impacting a patient’s recovery from spinal fusion,” said Dr. Khoi Than of Oregon Health & Science University in a prepared statement. “We suspected post-op therapy could have meaningful impact, so we decided to look at two of the industry’s leading bone growth stimulators head-to-head. There’s more work to be done, but our initial data is very interesting.”
The FDA has approved the use of multiple non-invasive electrical stimulation therapies to support post-operative bone growth since 1990. The therapies use different underlying technologies and vary significantly in treatment regimen, ease-of-use and effectiveness.
Once-daily treatment of using Vista, Calif.-based DJO Global’s CMF technology stimulates the factors in the bone healing cascade that help improve bone healing, according to two previous studies. CMF SpinaLogic is a lightweight device that can be applied over a brace or clothing after lumbar spine fusion surgery and offers one-button start/stop as well as built-in compliance tracking, according to the company . Patients receive personalized service from highly trained account representatives available to size, fit and train.