UI participating in multi-site clinical trial for post-traumatic osteoarthritis

University of Iowa Health Care is one of nine leading research centers participating in a new clinical trial testing the ability of an off-patent drug to slow or prevent osteoarthritis. The first-of-its-kind trial is sponsored and directed by the Arthritis Foundation and will focus on patients at high risk for post-traumatic osteoarthritis (PTOA) in the knee.  

Osteoarthritis (OA) affects over 30 million Americans and 500 million people globally and is one of the most common causes of disability in adults. Post-traumatic osteoarthritis is a type of OA that develops after a joint injury, including a fracture, ACL tear, ligament strain or meniscus injury. Currently there are no proven treatments to slow or reverse OA progression, and previous research aimed at developing OA treatments has only involved patients with late-stage OA and significant knee pain. 

“This research is extremely important as there is a subset of ACL injury patients that are susceptible to getting early arthritis in their knee. The PIKASO study will be a randomized trial of using a medication after the ACL injury and surgery to hopefully mitigate this early arthritis issue for these patients,” says Brian Wolf, MD, professor of orthopedics and rehabilitation and the John and Kim Callaghan Chair in Sports Medicine. “The UI team is one of a few selected centers that will help enroll patients into this study.  UI has been intimately involved in the design of the study which will be unique amongst ACL research studies.” 

Wolf and Don Anderson, PhD, professor of orthopedics and rehabilitation and the Richard and Jan Johnston Chair of Orthopedic Biomechanics and Vice Chair of Research in the Department of Orthopedics and Rehabilitation, are co-principal investigators for the UI Post-Injury Knee Arthritis Severity Outcomes (PIKASO) trial site. 

The PIKASO trial is a randomized phase II clinical trial that 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. The trial will measure changes in joint structure using advanced imaging techniques and functional improvements using innovative biomechanics measurements. Positive results from this trial could enable surgeons to immediately prescribe the drug before a patient undergoes surgery to slow the disease progression or fully prevent PTOA. 

The trial is 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 conduct randomized clinical trials in osteoarthritis under a common master protocol. 

In addition to the UI, the institutions involved in the trial include: 

• 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 Kentucky 
• The Ohio State University 
• Emory University 
• Hospital for Special Surgery