Change from baseline following treatment
Double-Blind Study Proves Significant Relief of Pain and Symptoms from BioniCare for Patients with Knee Osteoarthritis
A multicenter, prospective, randomized, placebo-controlled clinical study was conducted to evaluate the safety and efficacy of the BioniCare Knee Device in the management of osteoarthritis. Patients were maintained on NSAID and/or analgesic therapy throughout the study and were randomly assigned use of an active or inactive (placebo) BioniCare Knee Device for three months.
Relief of pain and stiffness and improvement in function of patients with the BioniCare Knee Device was significantly greater than with NSAID therapy and/or analgesics alone. Additionally, there were no serious adverse events.