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
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.
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
PIKASO Trial
Rationale & Design
This manuscript outlines the rationale, study design and implementation of the PIKASO trial, which aims to prevent the onset of post-traumatic osteoarthritis after ACL repair.
Read ManuscriptClinical 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
- University of Iowa, Iowa City, IA
- Site Principal Investigator: Donald D. Anderson, 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
Osteoarthritis Research Program
The Arthritis Foundation’s osteoarthritis (OA) program aims to accelerate the development of effective, evidence-based solutions to improve outcomes for people living with OA.
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