Preventing Injured Knees From osteoArthritis: Severity Outcomes
Key facts
- Who runs it
- Brigham and Women's Hospital
- Where
- Atlanta, Boston, Chapel Hill, Cleveland, Columbus, Iowa City, Lexington, New York, and Omaha, United StatesSee the 9 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 512 people, planned
- Started
- 6 May 2024
- Expected to end
- Dec 2030
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Metformin
- Placebo
- Record updated
- 15 October 2026
Who can take part
- Age
- 18 years to 45 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- Age 25-45 or Age 18-24 with preoperative KOOS Pain <80 (0-100, 100 best) recorded at least 14 days after the day of ACL injury
- Plan to undergo ACL reconstruction within 12 months of injury
Who cannot take part
- History of prior ACL tear on the index knee, with or without reconstruction
- Applying for or receiving Workers' Compensation for their knee injury
- Concomitant avulsion fracture of index knee that will be treated surgically
- Concomitant posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament injury on index knee requiring surgical repair/reconstruction
- Insufficient time for recruitment and drug titration: Surgery scheduled for <14 days from the time of screening
- Diabetes mellitus or diabetic ketoacidosis
- Acute or chronic renal insufficiency
- History of ACL tear on the contralateral knee within the past 12 months
- Diagnosis of cognitive impairment or otherwise unable to provide informed consent
- Presence of a condition or abnormality that in the opinion of the surgeon investigator would compromise the safety of the patient or the quality of the data
- Inflammatory arthritis
- Pregnancy and/or lactation, or plans to become pregnant in the next 12 months
- Known contraindication to metformin
- Current use of metformin or topiramate
- Joint space narrowing AND definite osteophyte(s) on weightbearing radiograph on index knee
- Tibial plateau fracture on index knee
- Contraindication to MRI
- Unable to speak and understand English
- Date of injury more than 6-months ago, relative to date of screening
- Plan for allograft at time of consent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Where in United States
- Emory UniversityAtlanta, United StatesContact: Gregory D Myer, PhD (principal investigator)Taking people
- Brigham and Women's HospitalBoston, United StatesContact: Rachel LovejoyTaking people
- The University of North Carolina at Chapel HillChapel Hill, United StatesContact: Joe M Hart, PhD (principal investigator)Taking people
- Cleveland ClinicCleveland, United StatesContact: Kurt Spindler, MD (principal investigator)Taking people
- The Ohio State UniversityColumbus, United StatesContact: Laura C Schmitt, PT, PhD (principal investigator)Taking people
- University of Iowa Hospitals and ClinicsIowa City, United StatesContact: Don D Anderson, PhD (principal investigator)Taking people
- University of KentuckyLexington, United StatesContact: Austin V Stone, MD, PhD (principal investigator)Taking people
- Hospital for Special SurgeryNew York, United StatesContact: Scott A Rodeo, MD (principal investigator)Taking people
- University of Nebraska Medical CenterOmaha, United StatesContact: Elizabeth A Wellsandt, PT, PhD (principal investigator)Taking people
About the trial
What the trial wants to find out
This study is being done to find out if metformin is effective at reducing pain by delaying the onset of post-traumatic osteoarthritis (PTOA) after anterior cruciate ligament (ACL) reconstruction. This research study will compare metformin to placebo. The placebo tablet looks exactly like metformin, but contains no metformin. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.
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Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat type II diabetes. Notably, it also has anti-inflammatory effects, suggesting it could benefit people who have an ACL injury and are undergoing ACL reconstruction.
The 2 groups in the trial
- MetforminTreatment being tested
3x500mg metformin hydrochloride (HCl) extended-release (ER) tablets taken orally once a day for 1 year
- PlaceboPlacebo, for comparison
3x metformin placebo tablets matching metformin extended-release taken orally once a day for 1 year
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Preventing Injured Knees From osteoArthritis: Severity Outcomes (PIKASO)
- Fit questions
- Built from NCT06096259, who can take part
- Publications
- Record updated
- 15 October 2026