Arthritis Foundation Announces First-Ever Foundation-Directed Post-Traumatic Osteoarthritis Clinical Trial

ATLANTA (October 12, 2023) — Today, World Arthritis Day, the Arthritis Foundation announced the launch of the first-ever clinical trial directed and sponsored by the Foundation. It will focus on patients at high risk for post-traumatic osteoarthritis (PTOA) in the knee. The Preventing Injured Knees from osteoArthritis: Severity Outcomes (PIKASO) Trial marks one of the first multi-stakeholder collaborative initiatives of the Arthritis Foundation’s Osteoarthritis Clinical Trials Network (OA-CTN), a multi-year, $20 million investment in creating an infrastructure to allow leading research centers to execute randomized clinical trials in osteoarthritis (OA) under a common master protocol.

The PIKASO Trial is the first-of-its-kind trial after knee joint injury. To date, there have not been any treatments proven to slow or reverse OA progression, even though OA is a devastating disease and might take decades to fully develop. Until PIKASO, research in developing OA treatments has only involved patients with late-stage OA and significant knee pain.

A recent manuscript  published in the Annals of Rheumatic Diseases led by Dr. Felson suggests studying patients after they experience knee trauma could lead to development of new treatments.

The five-year PIKASO Trial, a randomized phase II clinical trial, will examine the use of the off-patent drug Metformin in patients with major knee injury who are at high-risk for developing PTOA in the knee after anterior cruciate ligament (ACL) reconstruction. Positive results from this trial would have the potential to enable surgeons to immediately prescribe the drug before a patient undergoes surgery to slow the disease progression, or even fully prevent PTOA.

“The PIKASO Trial is the largest science initiative in the Arthritis Foundation’s 75-year history,” said Steven Taylor, President & CEO of the Arthritis Foundation. “The infrastructure and thought leaders of the OA-CTN allowed us to bring this project to fruition — a complex clinical trial that involves the collaboration of multiple world-class research centers and a stellar interdisciplinary team of scientists.”

As the first trial sponsored and directed by the Arthritis Foundation, the PIKASO Trial will measure changes in joint structure using advanced imaging techniques and functional improvements using cutting-edge biomechanics measurements. The trial will bring together renowned scientists from the following institutions:

• Mass General Brigham, the trial’s clinical coordinating center
• Cleveland Clinic, the imaging center that will coordinate the collection and analysis of MRI data
• University of North Carolina at Chapel Hill, the center that will coordinate the trial’s biomechanical and function assessments
• University of Nebraska Medical Center
• University of Iowa
• University of Kentucky
• The Ohio State University
• Emory University
• Hospital for Special Surgery 

"The launch of the PIKASO Trial is a major milestone in achieving the vision of the OA-CTN, which has been to find promising therapies for OA,” said David T. Felson, MD, MPH, professor of medicine and epidemiology at Boston University and corresponding author of the journal article, New approach to testing treatments for osteoarthritis: FastOA. “By serving as the convener, the Arthritis Foundation is helping colleagues across the country collaborate like never before to make tangible progress in scientific advancement."

The OA-CTN: Filling a Need

As a result of expert committee meetings and Arthritis Foundation-funded research, the OA-CTN was formed to share expertise and accelerate cutting-edge research to relieve the burdens of patients at risk for developing OA. In addition to the PIKASO trial, participating centers and trial sites work on a variety of additional research projects intended to advance OA clinical research, such as:

• The MOCHA Clinical Trial, studying montelukast as a potential chondroprotective treatment following anterior cruciate ligament reconstruction (ACLR)
• The CoMeT (Corticosteroid Meniscectomy) Clinical Trial — studying whether an injection of long-acting triamcinolone at the time of knee surgery to remove meniscus cartilage can slow or stop OA disease progression
• The “Biomechanical Changes Following ACL Injury that Influence the Development of Posttraumatic Osteoarthritis” Study — aiming to determine the early time course of relevant biomechanical changes of post-ACLR and association between biomechanics and patient-reported outcomes

 As the most common form of arthritis, OA affects over 30 million Americans and 500 million people globally. It is also one of the conditions most frequently associated with disability, together with diabetes and dementia, according to a study published in The Lancet Rheumatology. There is also an increased risk of developing OA for those who are obese and have a history of joint injury, and OA is most found in women. Without disease-modifying drugs available, and with a history of little OA clinical trials to lean on, health care providers tend to focus on symptom management and encourage OA patients to increase their level of physical activity.

Learn more about how the Arthritis Foundation is leading the way in fueling scientific research and working toward a cure for arthritis: arthritis.org/science.

About the Arthritis Foundation

The Arthritis Foundation is fighting for all people who live with arthritis. As Champions of Yes, the Arthritis Foundation’s mission is to turn the obstacles arthritis causes into opportunities. The Arthritis Foundation champions life-changing solutions and medical advancements, and it also provides ways for people to connect, break down barriers in health care and join the fight to conquer arthritis — uniting hearts, minds and resources to change the future of arthritis. To join the fight to conquer arthritis, visit arthritis.org.