5 quick facts on the Orthofix Cervical-Stim clinical study

Written by Laura Dyrda | November 10, 2014 | Print  |

The first large-scale clinical study to evaluate the pulsed-electromagnetic fields technology to see if the therapy can improve osteogenesis in Type II odontoid fractures is expected to launch using the Orthofix Cervical-Stim device as an adjunct to standard immobilization with a rigid collar.


Here are five things to know about the study:


1. It will be a prospective double-blind randomized placebo-controlled multicenter clinical trial on the Odontoid Fracture Study to investigate the safety and effectiveness of PEMF therapy with the system.


2. The study will include 360 patients who are 50 years old or older. There will be up to 50 sites in the United States study.


3. Participants will be randomized into the two-to-one ratio to either an active or placebo control device.


4. The patients will be followed for 12 months after treatment.


5. The study is a result of Orthofix's strategy for conducting trials to expand its PEMF indications.


"Typically we see Type II odontoid fractures in patients as the result of a bad fall or a car accident," said Richard Guyer, MD, an orthopedic spine surgeon and President of Texas Back Institute in Plano. Dr. Guyer is an investigator in the study. "Despite immobilization or in some cases surgical fixation often the bones do not heal correctly. Cervical PEMF stimulation may provide us with an additional treatment approach that can enhance odontoid fracture healing."


The system is FDA-approved as a noninvasive adjunctive treatment for improving cervical fusion outcomes.


More articles on orthopedic devices:
8 key trends for the U.S. minimally invasive spine technology market
Wright Medical's sales up 24% in 3Q: 10 things to know
24 spine devices receive FDA 510(k) clearance in October

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