CHAPEL HILL — Today is World Arthritis Day and the Arthritis Foundation marked the day with the announcement of their first-ever sponsored and directed clinical trial. The trial, called the Post-Injury Knee Arthritis Severity Outcomes (PIKASO) trial, will focus on patients at high risk for post-traumatic osteoarthritis (PTOA) in the knee.
The PIKASO trial will require the collaboration of multiple research centers and scientists, including Mass General Birmingham, the Clevland Clinic, and the University of North Carolina at Chapel Hill, among others. UNC-CH will be the center charged with conducting biomechanical and functionality assessments for the trial.
According to Dr. Richard Loeser, director of the UNC Thurston Arthritis Research Center at the UNC School of Medicine, the trial will involve the efforts of both the Thurston Arthritis Research Center and the Department of Orthopedics and Department of Exercise and Sports Science. The latter will be where the biomechanical evaluations are performed.
“We are very excited UNC will be participating in this groundbreaking clinical trial,” said Loeser. “The goal of this study is to prevent the development of osteoarthritis after joint injury. There are no treatments available that can halt osteoarthritis from progressing once it starts, resulting in many patients needing joint replacement, and so prevention is key.”
Osteoarthritis (OA) of the knee is the most common form of arthritis, affecting 30 million Americans and 500 million globally. As mentioned, there are no drugs or other treatments available for OA; currently healthcare providers must focus on symptom management and encouraging physical activity.
The PIKASO Trial will be the first to study the use of the off-patent drug Metformin in patients with major knee injuries who are at high risk of developing PTOA. The hope is that positive results from this trial will allow surgeons to prescribe the drug before surgery to slow or even prevent PTOA. The 5-year-long study will be a randomized phase II clinical trial, measuring joint structure and function using cutting-edge biomechanics measurements.
“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 in today’s press release. “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.”
Note: This article and its headline have been corrected to clarify that this is the first clinical trial sponsored and directed by the Arthritis Foundation, and their first for post-traumatic osteoarthritis.