๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-25

Preventing Injured Knees From osteoArthritis: Severity Outcomes (NCT06096259)

Preventing Injured Knees From osteoArthritis: Severity Outcomes (PIKASO)

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Brigham and Women's Hospital

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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. 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.

Who can join: Review the eligibility criteria below.

Location: Emory University โ€” Atlanta, Georgia

Age range: 18 Years to 45 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (9 Sites)

  • Emory University โ€” Atlanta, Georgia
  • University of Iowa Hospitals and Clinics โ€” Iowa City, Iowa
  • University of Kentucky โ€” Lexington, Kentucky
  • Brigham and Women's Hospital โ€” Boston, Massachusetts
  • University of Nebraska Medical Center โ€” Omaha, Nebraska
  • Hospital for Special Surgery โ€” New York, New York
  • The University of North Carolina at Chapel Hill โ€” Chapel Hill, North Carolina
  • Cleveland Clinic โ€” Cleveland, Ohio
  • The Ohio State University โ€” Columbus, Ohio

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 525-8617

Email: fselzer@bwh.harvard.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—