UTHCT and Azalea Orthopedic join studies of new non-invasive treatment for osteoarthritis of the knee and hip.

Friday, February 11, 2005

The University of Texas Health Science Center at Tyler and Azalea Orthopedic and Sports Medicine are participating in studies of a new non-invasive medical device to treat patients with osteoarthritis of the knee and hip, said James McKinley, MD, a UTHSCT sports medicine specialist.

The BIO-1000™ System is made up of a soft Velcro wrap and a battery-operated device. It delivers mild electrical stimulation to the arthritic joint. The BIO-1000™ is designed as an additional therapy to reduce pain and other symptoms of osteoarthritis. It is made by BioniCare Medical Technologies, Inc., in Sparks, Md. UTHSCT and Azalea are the only two sites in East Texas that are participating in these clinical studies. Dr. McKinley is UTHSCT’s principal investigator in both clinical studies. William E. Schreiber, MD, is principal investigator in both studies at Azalea Orthopedic.

Osteoarthritis Knee Study
The purpose of this research study is to determine the long-term safety and effectiveness of the BioniCare® Stimulator System (Model BIO-1000™) for the reduction of pain and/or improvement of joint function in subjects with osteoarthritis of the knee.

“The BioniCare device is a welcome addition to the treatments available for osteoarthritis. It is not a drug and does not require surgery, and thus has no system-wide effects or side effects. This is an important benefit in light of recent problems with one of the popular arthritis medications,” Dr. McKinley said.

“The Bio-1000™ System can be used along with other current treatments. It has been shown to be effective in reducing pain and improving function in osteoarthritic knees,” he said.

Dr. Schreiber said, “We have seen significant improvement in pain relief and in activity level in the majority of patients who have used the BioniCare device since we started using it six months ago. It is almost unbelievable to be able to treat degenerative arthritis of the knee and hip without having to worry about side effects.”

The U.S. Food and Drug Administration has approved the BIO-1000™ as an additional therapy to reduce osteoarthritis knee pain and improve the function of the knee. Study participants will wear the device for at least six hours a day or while sleeping at night. About 400 medical and health care facilities around the country are seeking to enroll about 10,000 people in the study, which is scheduled to last three years.

A separate clinical study is evaluating the effectiveness of the BIO-1000™ in reducing pain and other symptoms of osteoarthritis of the hip. The FDA classifies the BIO-1000™ as an investigational device as far as its effectiveness in treating the hip, meaning it has not been approved by the FDA for marketing. One study goal is to determine if the device can decrease the need for or delay total hip replacement surgery, an invasive procedure that requires three to six months of rehabilitation. Participants in this study will wear the BIO-1000™ for at least six hours a day or while sleeping. UTHSCT and Azalea Orthopedic are two of only 100 health care facilities in the United States seeking to enroll about 2,000 participants.

Arthritis is the leading cause of disability in the United States, affecting 38 percent of women and 26 percent of men. More than 70 million Americans currently are diagnosed with some kind or arthritis or chronic joint symptoms, according to the U.S. Centers for Disease Control and Prevention. Osteoarthritis affects almost 21 million Americans.

For information about this clinical study, call UTHSCT ‘s Center for Clinical Research at (903) 877-7753. Or call Azalea Orthopedic at (903) 592-6811.

NOTICE: Protected health information is subject to electronic disclosure.