ALPHARETTA, Ga., Sept. 3, 2020 /PRNewswire/ -- Avanos Medical, Inc. (NYSE: AVNS) today announced the publication of a large, randomized, multicentered clinical trial comparing the safety and efficacy of COOLIEF* Cooled Radiofrequency ablation to hyaluronic acid (HA) injection for the management of chronic knee pain caused by osteoarthritis. The results from the clinical trial were published in the Journal of Bone & Joint Surgery, the official journal of the American Orthopedic Association.
Knee osteoarthritis is a painful and sometimes debilitating condition affecting more than 9 million people in the United States alone. Existing treatments consist of short-lasting and often repetitive nonsurgical options, followed by surgical intervention for those who are appropriate candidates. COOLIEF* Cooled RF is an FDA cleared minimally invasive procedure that has shown extended clinical durability in the management of knee OA pain.
This clinical trial enrolled 177 subjects that met inclusion criteria who were subsequently randomized to receive either cooled radiofrequency ablation (CRFA) or a single hyaluronic acid (HA) injection. Subjects were evaluated for pain (Numerical Rating Scale = NRS), function (Western Ontario & McMaster University Osteoarthritis Index = WOMAC), quality of life (Global Perceived Effect = GPE) and safety at 1, 3 and 6 months.
At the 6-month timepoint, 71.1% of subjects receiving CRFA reported ≥ 50% pain relief compared to 37.8% of subjects receiving HA. Those receiving CRFA had a 48.2% improvement in WOMAC score at 6 months, compared to 22.6% of subjects treated with HA. Additionally, 72.4% of subjects in the CRFA group reported improvements in GPE compared to 40.2% in the HA group.
"I am very encouraged by the results from this clinical trial," said Dr. Lynn Kohan, associate professor at the University of Virginia Medical School, an investigator in the clinical trial. "The non-operative knee OA patient used to be one of my hardest patients to treat because there simply weren't safe and effective treatments with good clinical durability. Now, when I see these patients, I am excited to share this treatment option with them."
While the manuscript published today in The Journal of Bone & Joint Surgery represents the 6-month timepoint, the clinical trial was designed to capture longer follow-up with subjects receiving CRFA. The 12-month, 18-month and 24-month timepoints will be reported in future publications.
"We are excited to announce the publication of this trial," said Tom Kupec, vice president and general manager, interventional pain at Avanos, "and I am most pleased about the fact that these results show tremendous consistency in response when compared to previously published trial data on COOLIEF* Cooled RF. We continue to invest in high-quality clinical research and are pleased that these results were accepted for publication in such a prestigious journal."
About COOLIEF* Cooled RF: COOLIEF* Cooled RF uses water-cooled technology that enables more RF energy to safely deactivate pain-transmitting sensory nerves. This creates a larger, spherical lesion that distally projects 45% or greater beyond the probe's tip, allowing physicians to approach the target nerve from any angle. These features increase the likelihood of successful ablation and improve patient outcomes. COOLIEF* Cooled RF has been shown to provide up to 24 months of pain relief, improved physical functionality, and reduced drug utilization.
About Avanos Medical:
Avanos Medical (NYSE: AVNS) is a medical technology company focused on delivering clinically superior breakthrough medical device solutions to improve patients' quality of life. Headquartered in Alpharetta, Georgia, Avanos is committed to addressing some of today's most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Avanos develops, manufactures and markets its recognized brands in more than 90 countries. For more information, visit www.avanos.com and follow Avanos Medical on Twitter (@AvanosMedical), LinkedIn and Facebook.
SOURCE Avanos Medical, Inc.