Avanos Medical announced that its study comparing COOLIEF cooled radiofrequency to hyaluronic acid (HA) in the management of knee pain achieved its primary endpoint with a statistically significant improvement in knee osteoarthritis patients experiencing at least 50 percent reduction in knee pain at 6 months after treatment (p < 0.0001).
COOLIEF patients also achieved a statistically greater improvement in their functional outcomes when compared to the HA group at this 6-month time point (p < 0.0001). The full study results will be submitted for presentation and publication in a peer-reviewed journal later this year.
“These positive results are clinically relevant to the over 30 million people worldwide living with osteoarthritis pain, many of whom cannot find reliable long-term pain relief from corticosteroid and hyaluronic acid injections or are not appropriate candidates for surgical options,” said orthopaedic surgeon Antonia Chen, M.D./M.B.A. and the Lead Principal Investigator for the trial.
“As a surgeon who focuses on total joint replacement, these new findings are very important in broadening our knowledge of how to go beyond traditional methods of pain management, so we can better serve our non-surgical patients and potentially help our surgical patients control their pain and allow them to modify their health for improved procedural outcomes.”
This was a prospective, randomized, multi-center, comparison trial that included 177 patients at 10 sites. Patients with osteoarthritis of the knee were randomized to receive COOLIEF* Cooled Radiofrequency Thermal Ablation or a single injection of a commercially available HA. For patients treated with COOLIEF, 71.1 percent of patients received at least 50 percent reduction in pain at 6 months compared to 37.8 percent for those treated with HA.
COOLIEF patients showed a mean reduction of 4.1 points on the 10-point Numeric Rating Scale (NRS pain scale). Based on the WOMAC, the CRFA group reported a statistically significant mean functional improvement (WOMAC) change from baseline of 49% as compared to a 21% change in the HA group at the 6-month evaluation.
Lisa Kudlacz, Vice President and General Manager, Global Interventional Pain at Avanos said, “Non-opioid, minimally invasive approaches to help manage chronic pain in patients with osteoarthritis of the knee and hip are urgently needed – especially in light of the opioid epidemic.
The positive result from this trial combined with the results of the Davis, et ali steroid comparison study continues to demonstrate that COOLIEF provides consistent, durable pain relief associated with this disease and offers patients a solution that provides them long lasting pain relief without the side effects associated with opioids.”
“The results of this study reinforce the findings of previous studies and represent another milestone in our strategy to increase the adoption of COOLIEF* as a leading non-opioid treatment for patients in chronic pain,” said Joe Woody, Chief Executive Officer at Avanos. “Accelerating our investment in clinical trials is an important component of our investment strategy in COOLIEF*, as we build a strong compendium of clinical evidence that demonstrates the value of this therapy to both patients and payors.
“Last year we successfully launched our first direct-to-patient television commercials and building upon its momentum, recently expanded our campaign in additional U.S. markets to further increase patient awareness of COOLIEF* as a unique and effective solution to treat chronic pain. Our efforts to directly reach patients, combined with our focus on clinical evidence and the trial’s superior results, position us to successfully target the $1 billion hyaluronic acid market and bring much-needed non-opioid relief to those in pain.”
Source: Company Press Release