Dr. Don Buford, MD
Dr. Don Buford, MD, applying a sam 2.0 device to a patient's knee for the treatment of knee osteoarthritis pain for NIH-funded clinical study.
DALLAS, April 5, 2023 (Newswire.com) - The Texas Orthobiologics regenerative medicine and sports orthopedics center located in Dallas, Texas, is conducting innovative clinical research on sustained acoustic medicine (sam®) in a randomized controlled trial on knee osteoarthritis. The pivotal confirmation study expands the use of sam ultrasound treatment across a diverse population of ethnicities, minorities, and patients with health disparities to effectively treat knee osteoarthritis without the need for surgical intervention.
"I am excited to be a clinical investigator in this important study to expand access to new patient populations in the United States needing safe and effective treatment of knee OA," clinical investigator and regenerative medicine pioneer Don Buford, MD, said.
The active clinical study is evaluating the effectiveness of sam ultrasound for improving function, soft tissue healing, and reducing pain in the knee joint. The study expands on the results of prior 2021 research on sam ultrasound for knee osteoarthritis and injury healing, including a recent 2023 pragmatic clinical study on sam ultrasound for restoring patient function after an injury.
"The use of drugs and surgery are mainstay treatments for most patients, and sam ultrasound is a unique noninvasive therapy for healing and pain control," Dr. Buford said. "At our Dallas center, we provide a concierge medicine for patients with joint pain, sports injuries, and back pain using regenerative medicine approaches and, if necessary advanced surgical techniques, to help our patients with a better quality of life."
Knee osteoarthritis is a major public health issue, with treatments including oral medication, joint injections, or knee replacement. Sustained acoustic medicine is the first class of FDA-cleared multi-hour home-use pain relief ultrasound devices that promote soft tissue healing and joint circulation.
"The interest in sam ultrasound treatment from our patients has been overwhelming, and our office research staff have had excellent enrollment of patients," Dr. Buford said. "Our team is excited to offer this new mechanobiological treatment to our patients and better understand implementation of this noninvasive treatment to a diverse population of knee osteoarthritis patients."
According to the Osteoarthritis Action Alliance, the Centers for Disease Control and Prevention (CDC) estimates that one in four people, roughly 54.4 million U.S. adults, have some form of arthritis with osteoarthritis being the most common form affecting 32.5 million adults. Out of those 32.5 million, 43% of people are 65 or older and 88% of people are 45 or older. It is projected that 78 million adults will have some type of arthritis by the year 2040.
"We are measuring the reduction in knee arthritis pain and improvement in function that patients get with the sam® wearable ultrasound-based device," Dr. Buford said. "This study will give yet another FDA on-label indication (we hope) for the sam® technology that is already FDA-cleared and in widespread use across the USA. sam ultrasound is a great biology-based noninvasive therapy for pain control and healing."
The cost associated with osteoarthritis is $136 billion annually, the third most rapidly rising condition associated with disability, after diabetes and dementia. Medical expenditures are estimated at $65 billion. Osteoarthritis increases the risk of developing heart disease by 50%.
"On a daily basis, people suffer pain with greater fatigue, levels of disability, and activity limitations," Dr. Buford said. "Severe joint pain can be quite common and have an impact on the quality of life."
Osteoarthritis can lead to depression and social isolation as the pain can cause fatigue and result in loneliness. Regular pain also causes activity and work limitations, with some people unable to bend or kneel without difficulty.
About ZetrOZ Systems
ZetrOZ Systems is leading healing innovations in sports medicine, developing wearable bioelectronic devices for the delivery of sustained acoustic medicine (sam®). Researched and funded by the federal government, ZetrOZ is built on the proprietary medical technology of +46 patents and is the exclusive manufacturer and developer of the sam® product line, which is designed for the treatment of acute and chronic musculoskeletal conditions.
To learn more about ZetrOZ, visit zetroz.com.Contact Information:
Original Source: America's #1 Regenerative Medicine and Orthopedic Surgery Practice in Dallas, Texas, Leads NIH-Funded Clinical Research Study on Sustained Acoustic Medicine for Knee OA