PIKASO Clinical Trial

PIKASO (Preventing Injured Knees from Osteoarthritis Severity Outcomes) is a collaborative, double-blind, placebo-controlled, randomized clinical trial testing whether metformin can slow or prevent osteoarthritis progression in people with major knee injuries.

Trial Overview

Over 32 million people in the U.S. have clinically-diagnosed osteoarthritis. Leading the efforts to find a cure for this debilitating, degenerative joint disease, the Arthritis Foundation, along with experts in clinical practice and academia, has launched the PIKASO clinical trial. This randomized phase II study will test if metformin, a drug widely used for managing Type 2 diabetes, can slow or even prevent post-traumatic osteoarthritis progression.

What type of study is the PIKASO trial?

PIKASO is a prevention study. It tests whether metformin, a drug commonly used to treat Type 2 diabetes, can prevent or delay the onset of osteoarthritis in people who have had an ACL tear and are scheduled for surgery.

Why study the medication metformin?

Metformin is very safe, even for people without Type 2 diabetes. It is low-cost and has mounting evidence of delaying the onset of osteoarthritis. Studies of metformin in animals and humans show potential for disease-modifying benefits in people diagnosed with osteoarthritis. PIKASO is testing whether metformin can prevent or delay the onset of post-traumatic osteoarthritis after a knee injury.

Are there risks associated with the study medication?

Metformin has known side effects, including abdominal or stomach discomfort, decreased appetite, diarrhea, lightheadedness, nausea and dizziness. These side effects are usually temporary and resolve with time as the body adjusts to the medication.

What happens when a patient is enrolled?

Patients will receive standard-of-care postoperative physical therapy. In addition, they will receive assessments of thigh muscle strength and how well they move, and advanced MRI imaging. Patients will complete questionnaires to monitor the status of the knee joint (e.g. pain, function). They will be given either metformin or a placebo, and their outcomes will be assessed regularly over two years.

For Providers:
National Clinical Trial No. for the PIKASO clinical trial
NCT06096259

Scientific Publications

PIKASO Presentation

Jason Kim, PhD, vice president of Osteoarthritis Programs, shares a technical overview of the PIKASO trial and its progress. Check back often for updates to the presentation as new data comes in.

Download Presentation

Clinical Trial Sites

Mass General Brigham, Boston, MA
- Study Co-Principal Investigators: Morgan Jones, MD, MPH, and Cale Jacobs, PhD, ATC
University of Nebraska Medical Center, Omaha, NE
- Site Principal Investigator: Liz Wellsandt, PT, PhD
University of Kentucky, Lexington, KY
- Site Principal Investigator: Austin Stone, MD, PhD
The Ohio State University, Columbus, OH
- Site Principal Investigator: Laura Schmitt, PT, PhD
Emory University, Atlanta, GA
- Site Principal Investigator: Greg Myer, PhD
Hospital for Special Surgery, New York, NY
- Site Principal Investigator: Miguel Otero, PhD
Cleveland Clinic, Cleveland, OH, and Weston, FL
- Site Principal Investigator: Kurt Spindler, MD
University of North Carolina at Chapel Hill, Chapel Hill, NC
- Site Principal Investigator: Joe Hart, PhD, ATC

Clinical Trial Core Sites

Brigham Coordinating Center (BriCC)
- Brigham and Women’s Hospital, Boston, MA
- Site Principal Investigator: Elena Losina, PhD
Osteoarthritis Imaging Center (OIC)
- Cleveland Clinic, Cleveland, OH
- Site Principal Investigator: Xiaojuan Li, PhD, and Carl Winalski, MD
The Biomechanics and Functional Outcomes Center (BFUNC)
- University of North Carolina, Chapel Hill, NC
- Site Principal Investigator: Brian Pietrosimone, PhD

Joint Matters

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Meet the PIKASO Researchers

Get to know the researchers inside the PIKASO trial, the first Arthritis Foundation-directed clinical trial aimed at preventing post-traumatic osteoarthritis (PTOA).

Learn More

PIKASO Launch

The Arthritis Foundation’s Osteoarthritis Clinical Trials Network (OA-CTN) is a $20 million infrastructure investment to launch and execute randomized clinical trials in osteoarthritis.

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