NeuroSpine

DJO® Announces Presentation of Independent Clinical Study Using CMF™ Device

March 18, 2019

VISTA, Calif.–(BUSINESS WIRE)–DJO®, a leading global provider of medical technologies designed to get and keep people moving, announced today Oregon Health & Science University’s independent study of patients who have undergone lumbar fusions with use of non-invasive electrical stimulation. The results, presented at Spine Summit 2019 in Miami, Florida, highlight the fusion and re-operation rates of 46 study participants.

This study was led by Khoi Than, M.D., of Oregon Health & Science University (Portland, Oregon) and presented at Spine Summit, Miami, 2019 by medical student, Barry Cheaney II.

Highlights from the OHSU study include:

All patients included:

  • 46 total patients studied; 27 CMF™, 19 PEMF
  • Among CMF™ patients, 77.8% (21) demonstrated solid fusion
  • None of the patients treated with the CMF™ device required re-operation for pseudarthrosis

“There are a number of factors impacting a patient’s recovery from spinal fusion,” said Khoi Than, M.D., of Oregon Health & Science University. “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 utilize different underlying technologies and vary significantly in treatment regimen, ease-of-use and effectiveness. Combined Magnetic Field Technology from DJO® is a once daily, 30-minute non-invasive electromagnetic stimulation indicated as an adjunct to lumbar spine fusion. Once-daily treatment of CMF™ Technology stimulates the factors in the bone healing cascade that help improve bone healing1,2. The pivotal study: a prospective, randomized, double blind trial, showed statistically significant healing with use of CMF™ over placebo (21 percentage pts). Results of the study showed that CMF™ can provide a 49% increase in overall healing rate3.

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. Patients receive personalized service from highly trained account representatives available to size, fit and train.

More information about CMF™ SpinaLogic® can be found here.

Abstracts of the 2019 Annual Meeting of the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves are available on the Journal of Neurosurgery website.

Individual results may vary. Neither DJO, LLC nor any of its subsidiaries dispense medical advice. The contents of this document do not constitute medical, legal, or any other type of professional advice. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you.

About DJO®

DJO® is a leading developer and distributor of high-quality medical devices that provide proven solutions for musculoskeletal health, joint reconstruction, vascular health, and pain management. The Company’s extensive range of products and integrated technologies address the orthopedic continuum of care from performance and mobility to surgical intervention and post-operative rehabilitation; enabling people around the world to regain or maintain their natural motion. For additional information about DJO, please visit www.DJOGlobal.com.

1. McLeod, K.J., Rubin, C.T., The Effect of Low Frequency Electrical Fields on Osteogensis. J. Bone Joint Surg., 74A: 920-929, 1992
2. Ryaby, J.T., et al., The Role of Insulin-like Growth Factor in Magnetic Field Regulation of Bone Formation, Bioelectrochemistry and Bioenergetics. 35: 87-91, 1994
3. Linovitz R, Pathria M,Bernhardt M, et al. Combined Magnetic Fields Accelerate and Increase Spine Fusion: A Double -Blind, Randomized, Placebo Controlled Study. Spine. 2002 July; 27(13):1383-1388.

Contacts

Media Contact:
Brittany Knudson
760.734.5628
Brittany.knudson@djoglobal.com

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Drue De Angelis

Drue is Managing Partner for The De Angelis Group, Executive Search firm exclusively for the Ortho & Spine industry.

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