PIKASO Clinical Trial

PIKASO (Preventing Injured Knees from Osteoarthritis Severity Outcomes) is a collaborativedouble-blindplacebo-controlledrandomized clinical trial testing whether metformin can slow or prevent osteoarthritis progression in people with major knee injuries.

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Trial Overview

Over 32 million people in the U.S. have clinically-diagnosed osteoarthritis. Leading the efforts to find a cure for this debilitatingdegenerative joint diseasethe Arthritis Foundationalong with experts in clinical practice and academiahas launched the PIKASO clinical trial. This randomized phase II study will test if metformina drug widely used for managing Type 2 diabetescan slow or even prevent post-traumatic osteoarthritis progression.

What type of study is the PIKASO trial?

PIKASO is a prevention study. It tests whether metformina drug commonly used to treat Type 2 diabetescan 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 safeeven 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 effectsincluding abdominal or stomach discomfortdecreased appetitediarrhealightheadednessnausea 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 additionthey will receive assessments of thigh muscle strength and how well they moveand advanced MRI imaging. Patients will complete questionnaires to monitor the status of the knee joint (e.g. painfunction). They will be given either metformin or a placeboand their outcomes will be assessed regularly over two years.

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

Keeping Trials on Track

Lily Waddell coordinates clinical trialsincluding Arthritis Foundation-funded osteoarthritis researchto make sure they stay on course.

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Helping to Prevent Osteoarthritis

As part of the PIKASO research teamDr. Matthew Tao hopes to help improve patients’ quality of life.

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Sports Injuries Drive Researcher’s Work

Orthopedic surgeon Scott Rodeo brings clinical and research insights to arthritis prevention trial.

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Solving the Puzzle of Post-Traumatic OA

Don AndersonPhDbrings his expertise in osteoarthritis research to the PIKASO trial.

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Cracking the Case for OA

Janet L. Huebner has spent her career seeking answers to the mysteries of osteoarthritis.

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Scientific Publications

PIKASO Presentation

Jason KimPhDvice president of Osteoarthritis Programsshares a technical overview of the PIKASO trial and its progress. Check back often for updates to the presentation as new data comes in.

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PIKASO Trial

Rationale & Design

This manuscript outlines the rationalestudy design and implementation of the PIKASO trialwhich aims to prevent the onset of post-traumatic osteoarthritis after ACL repair.

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Clinical Trial Sites

Mass General BrighamBostonMA
- Study Co-Principal Investigators: Morgan JonesMDMPHand Cale JacobsPhDATC
University of Nebraska Medical CenterOmahaNE
- Site Principal Investigator: Liz WellsandtPTPhD
University of KentuckyLexingtonKY
- Site Principal Investigator: Austin StoneMDPhD
University of IowaIowa CityIA
- Site Principal Investigator: Donald D. AndersonPhD
The Ohio State UniversityColumbusOH
- Site Principal Investigator: Laura SchmittPTPhD
Emory UniversityAtlantaGA
- Site Principal Investigator: Greg MyerPhD
Hospital for Special SurgeryNew YorkNY
- Site Principal Investigator: Miguel OteroPhD
Cleveland ClinicClevelandOHand WestonFL
- Site Principal Investigator: Kurt SpindlerMD
University of North Carolina at Chapel HillChapel HillNC
- Site Principal Investigator: Joe HartPhDATC

Clinical Trial Core Sites

Brigham Coordinating Center (BriCC)
- Brigham and Women’s HospitalBostonMA
- Site Principal Investigator: Elena LosinaPhD
Osteoarthritis Imaging Center (OIC)
- Cleveland ClinicClevelandOH
- Site Principal Investigator: Xiaojuan LiPhDand Carl WinalskiMD
The Biomechanics and Functional Outcomes Center (BFUNC)
- University of North CarolinaChapel HillNC
- Site Principal Investigator: Brian PietrosimonePhD

Osteoarthritis Research Program

The Arthritis Foundation’s osteoarthritis (OA) program aims to accelerate the development of effectiveevidence-based solutions to improve outcomes for people living with OA.

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