Peer Reviewed Study Concludes That BioniCare® Combined with Knee Brace Provides Significant Improvement and Faster Recovery

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Treatment Option Gives Hope to 20 Million Living With Osteoarthritis of the Knee


A new study published in The American Journal of Orthopedics showed that 70 percent of patients who combined BioniCare, a non-invasive pulsed electrical stimulator from VQ OrthoCare®, with a joint unloading knee brace achieved significantly better clinical improvement, than with BioniCare stimulation treatment alone. The study consisted of more than 500 patients with osteoarthritis of the knee. The results show that the combination of BioniCare and a joint unloading knee brace is the most effective treatment option for OA of the knee. Patients with OA of the knee who use the treatment combination have the ability to quicken their recovery, regain knee functionality and defer or avoid higher-risk treatment options.

OA of the knee is a serious endemic cause of pain and disability. Although any age can be affected, it is increasingly prevalent with advancing age. The condition is caused by excessive catabolism and inadequate repair of articular cartilage in the diarthroidal joints. OA of the knee leads to matrix architecture disruption and loss of tissue resiliency. Patients report symptoms that include loss of function, stiffness, pain and swelling, and locking of the joint .

“More than 20 million patients are affected by OA of the knee and as many as 600,000 severe enough to warrant total knee replacement surgery annually. Although a wonderful and highly successful operation, it is expensive and potentially dangerous,” said Dr. David S. Hungerford, lead author and professor emeritus, Department of Orthopedic Surgery Johns Hopkins University. “This study shows that there is now an effective, non-surgical, non-pharmaceutical way to not only reduce symptoms, but also maintain and even increase physical activity. Thus far, only electrical stimulation with the BioniCare knee device has been shown to reduce the physical signs and symptoms of OA of the knee, and the brace has been shown to be effective in helping patients remain active while controlling symptoms. This study shows conclusively that by combining electrical stimulation and the brace, better results are achieved than either treatment modality alone.”

The peer-reviewed study was published in The American Journal of Orthopedics October 2013 issue and consisted of 225 study group patients with OA of the knee who were treated at 16 orthopedic and rheumatology practices. The control group saw 289 patients with OA of the knee treated at 57 orthopedic and rheumatology practices. Study group patients were maintained on best medical therapy in addition to stimulator-brace combination treatment, control patients were maintained on best medical therapy in addition to stimulator only treatment. For both groups, best medical therapy included weight loss, knee-strengthening exercises, and NSAIDs or analgesics. Corticosteroid injections and viscosupplementation were not allowed during the study. Outcome measures (seven total), inclusion criteria, and exclusion criteria was identical for both groups. Statistical analysis was independently performed by Novella Clinical.

The patients, at one month, three months and six month evaluations, achieved significantly better clinical improvement, at least 20 percent better, than with BioniCare stimulation treatment alone. After 12 months of treatment, the combination treatment was favored on all seven outcome parameters. The results prove that the combination of BioniCare and a joint unloading knee brace is the most effective treatment option for OA, reducing pain and associated symptoms, improving function, and deferring or avoiding more severe treatment options such as total knee arthroplasty.

Each year of the more than 600,000 patients, who require total knee joint replacements, one in 150 will die of total knee replacement surgery. Another five percent have major complications, including heart attacks, strokes, pneumonia, pulmonary embolism, and infections in the joints. The results of this new study have important implications to the healthcare system related to the potential savings from deferral of surgery, as well as the reduced drug usage, and complications from NSAIDs.

An earlier actuarial study by Milliman Global estimated that approximately $400 million per year could be saved, as a result of decreased costs of knee surgery by treatment with BioniCare alone. Similarly, treatment with BioniCare alone for one year resulted in 18 percent of patients being able to discontinue all pain and arthritis medications. Another 25 percent reduced their use of these drugs by 50 percent or more. The drug reductions and discontinuations from BioniCare treatment alone has the potential to generate more than $1 billion in savings to the U.S. healthcare system.

Since its FDA clearance in 2003, BioniCare has been prescribed to more than 100,000 patients nationwide. BioniCare was awarded the 2010 Innovations in HealthCare™ ABBY award for reducing costs of providing quality healthcare, as well as the 2010 TechAmerica High-Tech award for achievement in technology.

For more information on BioniCare, visit: To learn more about The American Journal of Orthopedics, visit:

About VQ OrthoCare®:
Founded in 1989 and based in Irvine, Calif., VQ OrthoCare® is a leading manufacturer and provider of non-invasive medical solutions focused on bone, joint and soft-tissue conditions. VQ OrthoCare's commitment to treating patients with respect and supporting them in achieving optimum outcomes is unmatched in the industry. VQ OrthoCare’s products include: SurgiStim4, OrthoStim4, Eagle, Catalyst-Elite and OActive knee bracing, Fast Start EMS and HVPC, VQ Vector, and the BioniCare systems (knee and hand/wrist). VQ OrthoCare is registered with the U.S. Food and Drug Administration as a medical manufacturer and specification developer.

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Jesse Page

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